Clinical Resume Samples

The Guide To Resume Tailoring

Guide the recruiter to the conclusion that you are the best candidate for the clinical job. It’s actually very simple. Tailor your resume by picking relevant responsibilities from the examples below and then add your accomplishments. This way, you can position yourself in the best way to get hired.

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O Price

Ozzie

Price

147 Fannie Cove

Philadelphia

+1 (555) 441 2592

147 Fannie Cove

Philadelphia

Phone

p +1 (555) 441 2592

Experience Experience

New York, NY

Clinical Trial Coordinator

New York, NY

Gerhold Group

New York, NY

Clinical Trial Coordinator

Perform other duties as assigned by management
Assist with management of study-level IP shipment to sites as necessary
Assist in implementing process improvement solutions/plans
Manage study databases and clinical trial management systems
Performs job duties with minimal supervision
Provide general administrative and coordination support to the clinical operations department and the development and continuous improvement of departmental procedures
Performing data entry into research databases

New York, NY

Clinical Trials Specialist

New York, NY

Dach-Gutkowski

New York, NY

Clinical Trials Specialist

Coordinate and perform a variety of duties involved in the collection of data in support of clinical trials research studies, through clinical assessments, interviews and observation to include interpretation and documentation of data
Follow established guidelines in the collection of clinical data and/or administration of clinical trials; assist in the determination guidelines for new protocols
Confer with site coordinators and physicians to explain protocol and to elicit compliance with regulations; ensure adherence to FDA and protocol guidelines
Prepare a variety of reports, documents and correspondence for regulatory agencies, participating clinical trials sites and internal purposes to assist in the ongoing monitoring and evaluation of the clinical trial's progress
Assist principal investigators and/or other members of the research team in the development of plans and protocols for clinical research studies
Review work of lower level personnel within designated areas and assist in training new personnel
Perform other related duties incidental to the work described herein

present

Houston, TX

Clinical Document Specialist

Houston, TX

Crooks Inc

present

Houston, TX

Clinical Document Specialist

present

Assist in writing and editing SOPs to keep current with industry changes on TMF management, quality and archival
Works with physicians and medical staff to improve clinical documentation for more accurate code assignments and a more accurate case mix
Establishes and maintains a system to track and analyze outcomes of documentation improvement program
Performs ongoing medical record review using documentation improvement guidelines to evaluate overall quality and completeness of clinical documentation
Assist with User Acceptance Testing during product development and release
Assists with Quality Management to ensure compliance of pathways and quality initiatives
Assist senior document specialists for performing internal audits

Education Education

Bachelor’s Degree in Nursing

Kaplan University

Bachelor’s Degree in Nursing

Skills Skills

Comprehensive health care, dental, vision, life and disability plans
Proficiency in hospital pharmacy practice, patient-centered care, advanced pharmacy practice, medication therapy management, and evidence-based medicine
Previous management or project management experience with demonstrated leadership ability
Excellent communication; interpersonal skills and influencing skills
Ability to determine the people, funding, materials and support to meet project goals and timelines
Proficiency with hospital computer systems, pharmacy technology, and pharmacy automation
Able to work in ambiguous, fast-paced environment
Able to work independently
Excellent time management skills (timelines, schedules, task prioritization)
Willing and able to travel up to 30% of time

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15 Clinical resume templates

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Manager of Clinical Pharamcy Services Resume Examples & Samples

5+ years of experience as a Clinical Pharmacist, 3 of which must have been in a hospital
Rph
Critical care, drug information and clinical experience

Clinical Unit Coordinator Resume Examples & Samples

5+ years community health or ambulatory clinic experience
Strong clinic background working with adults 18+
BSN / RN
Spanish-speaking

Clinical Assessment Temp Trainers Resume Examples & Samples

Preferred Licensed Psychologist
Minimum 5 years of experience with administration and interpretation of Clinical Assessments
Proficient in MS Office Suite
Proficiency with applications that run across the Worldwide Web
Overnight travel required
Effective Time Management
Professional and polished demeanor
Personal laptop ownership and use required
Please note: This is a temporary opportunity, billed through a third party
This is not an active opening, so you will not be immediately contacted. Thank you for your interest with HMH

Temporary Clinical Examiners Resume Examples & Samples

Administer and score a battery of individually administered tests
Ensure all tests and forms are completed accurately and submitted in a timely manner
Keep accurate records of assigned cases and examinees
Some travel may be required. Job Requirements
Minimum of Master's degree in Special Education, Psychology, Educational Psychology or Speech Language Therapy
Familiarity with a variety of individually administered clinical assessments and observational instruments
Access to a wide range of potential examinees, based on various demographic characteristics
Proficient in MS Office Suite (Word, Excel)
Proficiency with email and internet
Personal computer ownership and use required
Ability to work evening/weekend hours as needed

Head of Clinical Data Systems Resume Examples & Samples

BS/BA in a scientific or programming discipline
Minimum 12 years experience as a Clinical Data Manager in a CRO or pharmaceutical/biologics/biotechnology company with increasing scope of responsibility demonstrated
Experience in a pharmaceutical/biologics/biotechnology company must include management of outsourced CDM and clinical programming activities
Expert knowledge of eClinical processes, efficient design/build of an EDC data management system (Rave, Oracle RDC) and other Clinical Trial data/Data Management Systems
Intimate knowledge of regulations and industry adopted data standards, such as CDISC-SDTM and CDASH and other associated clinical data submission deliverables
Demonstrated advanced expertise with clinical programming in SAS (at least 5 years)

Director of Campaign Marketing, Clinical Resume Examples & Samples

Lead generation and revenue creation for field sales team and direct selling
Channel Support in the form of selling and marketing tools and training
North American campaign planning for Clinical solutions including school. and healthcare/non-school markets including Talent Assessment
Create, implement, and monitor marketing plan, campaign plan & budget for responsible area for new product launches and portfolio
Drive Pearson brand in responsible market segment
Events strategy for responsible area in alignment with North American Geography strategy
Competitive analysis & distinction, win loss analysis for responsible area
Customer segmentation
Support for Customer relationship management
Creation and successful implementation of marketing plan for responsible area
Identify customer needs and market trends and recommend pricing strategies

National Account Executive for Clinical Assessments Resume Examples & Samples

Designs strategies that address customer needs and issues while meeting assigned quota; targets and prioritizes accounts and activities; analyzes competitors' activities and adjusts appropriately; utilizes area, national and Per Diem resources effectively
Strategically plans sales calls by outlined objectives and action steps
Reads the market, recognizes trends, and communicates that information to the Area Management; Demonstrates knowledge of account history, the processes and procedures specific to each district, and the key issues for each account
Responds to customers requests and problems with appropriate timeliness and concern; Develops professional credibility and trust with the customer
Provides timely and complete information needed for consultants and outside resources to perform effectively in the territory; Uses voicemail and email appropriately; Updates Salesforce.com regularly
Knowledge of each clinical assessment to converse comfortably with customers and understand their needs; effectively communicates the major features, advantages, and benefits of each product; Displays a thorough knowledge of state and national clinical assessment and early childhood trends and movements in order to be at the right place at the right time

Senior Non-clinical Study Coordinator Assoc Resume Examples & Samples

50% Administrative oversight and management of operational aspects of outsourced studies at Shire approved CROs from study initiation (study time lines, budgets, protocols, test article availability & shipment) to report finalization. Coordinate internal (Shire NCD) and external (CRO) protocol review. Monitor study activity and data to ensure time lines are adhered to. Primary Shire point of contact with CRO
20% Administrative oversight of program finances (PO requisitions, invoices, vendor management), track study timelines and budget. Work with legal affairs and Global Procurement to ensure that requisite vendor contracts (MSAs, SOWs, CDAs, etc.) are created and maintained
10% Ensure alignment of Shire Internal Compliance/Quality Assurance Units and corresponding functions of CROs during all phases of regulated nonclinical work
10% Review study data on an ongoing basis and provide toxicologists with data summaries. Coordinate internal (Shire NCD) and external (CRO) report review. QC nonclinical sections of regulatory submissions
10% Ensure best practices are in place for operational efficiency within the department and externally with CROs

Clinical Trial Transparency Manager Resume Examples & Samples

50% Internal and External Transparency and Data Sharing Project Support
In collaboration with other members of the CTT team, the manager contributes to the public disclosure of clinical trial protocol information and results for clinical studies in line with regulatory requirements and Shire public disclosure policy and strategy
Transparency manager is responsible for preparing or managing the preparation of the content to be posted on external websites
The manager needs to interact closely with the clinical/statistical study team as well as with other key functions such as regulatory, compliance, corporate communications, legal, etc
Provide operational support to ensure the alignment of posted information across all external websites
Redacts and/or coordinates the redaction of patient sensitive or commercially confidential information
Assists with development and maintenance of processes and systems to optimize efficiency, maximize content reuse and ensure quality. Evaluates trends and identifies areas for improvement
Participates in industry working groups (e.g. DIA Disclosure Community) to ensure a firm understanding of the activities affecting transparency. Monitors the clinical trial transparency landscape, including regulatory requirements and industry trends
Supports CTT team for coordinating updates of on-going studies following protocol amendments or changes in monitoring information
Oversee/manage the review process to ensure timely and accurate postings, and to ensure that information is posted on appropriate public clinical trial registries and updated as required per regulations and internal SOPs
Responsible for managing/overseeing the management of external requests for access to Shire Clinical Trial Data including, but not limited to

Clinical Programs Lead Resume Examples & Samples

Bachelor’s degree or nursing qualification is required. Scientific/health care field preferred but not required. Advanced degree preferred
Significant clinical research experience (8+ years) with evidence of increasing responsibility within a pharmceutical company or CRO
Global clinical trial research experience
Experience leading cross functional teams
Participation in marketing application review and submission is preferred
Experience managing financial budgets is preferred
Must be able to design drug development programs as well as create program and/or study level documents
Strong knowledge of applicable computer and project management software packages
Demonstrated ability to present information to Shire management, CROs and external audiences (as applicable)
Ability to oversee and/or manage and communicate effectively with research vendors including negotiating contracts, reviewing request for proposals, analyzing scope of work, responding to inquiries and complaints
Strong interpersonal skill set necessary to create and maintain external collaborator relationships (e.g. Key Opinion Leaders)
Demonstrated ability to prioritize across program / study demands ensuring overall quality
Requires strong attention to detail and the ability to establish priorities schedule and meet deadlines
Ability to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands
Ability to work independently, take initiative and complete tasks to deadlines
Demonstrated ability to motivate & mentor staff
Displays a high level of professionalism with internal and external stakeholders
Develops project plan(s) to achieve long-term goals based on higher business level drivers and strategies
Demonstrated ability to create and manage program and/or study budgets including communication of overspend /underspend risk and mitigation efforts
Communicate with key internal and external stakeholders to ensure success and looks for opportunities for collaboration
Respectfully challenges current practices, decision or ideas to uphold quality or ethical standards

Clinical Document Specialist Resume Examples & Samples

Records management experience
Familiarity with various aspects of clinical trials and regulatory submissions. Current awareness of regulatory requirements for clinical trials (ICH/GCP)
Sufficient knowledge of regulatory requirements and guidelines (ICH/GCP to support records management
Ability to communicate effectively with external vendors, including issue escalation, and responding to enquiries and concerns
Must be able to work in a fast paced environment with demonstrated ability to prioritize multiple competing tasks and demands
Demonstrated ability to be flexible and to adapt quickly to chang

Director of Clinical Programs Resume Examples & Samples

Ensure performance standards are realistically set and attained for internal and external resources
Oversee management of sites and vendors to issue resolution if necessary
Align with team members from other functional areas regarding plarming, implementation, tracking, analysis and reporting of milestones

Clinical Trial Transparency Team Lead Resume Examples & Samples

40% Leads Internal and External Transparency and Data Sharing Projects and Strategic Transparency Initiatives
Leads internal core team and/or subteams in support of strategic transparency initiatives
Assesses impact, identifies action required, and communicates needs to applicable functions and senior management
Participates in industry working groups (e.g. DIA Disclosure Community SIAC) to ensure a firm understanding of the activities affecting transparency
Actively participates in external initiatives to represent the company position in support of transparency activity and development of industry standards
Delivers presentations to key functional areas and at all levels of the organization
Proposes and leads activities that support evolving strategy for clinical trial transparency
30% Process and System Development
Acts as owner of Clinical Trial Transparency processes
Lead Committees and cross-functional Working Groups to establish strategy and policy, develop and implement processes, and ensure compliance with global requirements
Evaluates trends and identifies areas for improvement. Leads process analysis efforts and identifies opportunities to improve efficiency and effectiveness
Represents Clinical Trial Transparency Group on internal and external work streams related to automation systems and other proposed changes that may impact policy and procedures related to clinical trial transparency
20% Operational oversight and overall strategy for Aggregate Spend Reporting
Collaborates with Corporate Compliance to develop department-specific data collection processes
Oversees data collection and formal reporting activities for Global Clinical Development Operations
Oversees monthly submission into Shire’s reporting database
Works closely with internal support functions including Finance, Supply Chain, and IT to ensure proper mechanisms are in place globally to capture required information
Promotes accurate reporting by ensuring GDCO meets or exceeds industry standards for recording and managing HCP payment requirements
Stays abreast of all international, federal and local reporting requirements
Advises leadership on changes to requirements as required
10% Resource Management
The Lead is responsible for oversight and development of internal and external resources
Oversees transparency operations to ensure requirements and timelines are met while maintaining high quality and continuously improving process efficiency
Works with the Transparency staff members to ensure alignment across all areas of transparency, including other related functional areas, business units, and global locations
Builds capabilities through mentoring/coaching
Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the teams and stakeholders in an open, balanced and objective manner
Development and maintenance of team budget
Sponsors training programs for department staff
Bachelor's degree in scientific or related field is required; advanced degree is preferred
Minimum 10 years pharmaceutical / biotechnology or relevant industry experience
Experienced in leading global cross-functional teams in a matrix organization
Ability to effectively represent the department internally, as well as the company externally
Excellent negotiation skills, conflict resolution, decision making skills, communication (oral and written) and presentation skills
Ability to interact well with all levels of the organization
Coordination and planning of budgets, people and time management
Problem solving at a strategic level, working with others to reach a resolution
Ability to discuss strategic and sensitive issues
Confident and influential approach

Lead Clinical Standards Specialist Resume Examples & Samples

30% - Delivering Excellence: Takes leadership role in coding and standards project implementation
Acts as Standards area project manager for selected standards / coding projects
Mentors team members via matrix relationships in standards and coding implementation and optimal usage
Owns, governs and maintains designated GCDO developed standards models (including but not limited to: SDTM ,CDASH, Terminology, ADaM, TFLs, document templates, questionnaires). Includes periodic assessment of standards content with respect to compliance and industry impacts
Lead assessment, implementation, integration and governance of systems and tools to support, manage, govern and report on standards
Ensure enforcement and assessment of standards compliance
Collaborates closely with data management service providers to ensure appropriate management, training and deployment of Shire’s standards within the service providers infrastructure
Represents Shire and Global Clinical Development Operations as a member of industry content development groups (e.g. CDISC)
Leads a R&D Standards Area Working Group/Team
Supports standards library, knowledgebase/governance portal and other applications. Coordinates with IT where necessary
Develops or assists in the development of tools to manage standards
Contributes to budget forecasting and resourcing requirements
20% - Accountability and Ownership: Drives accountability at every possible level
Collaborates with Standards Team lead to identify and resolve issues impacting goal attainment
Develops and delivers training programs to affected internal and external staff
Ensures CROs and Shire are deploying standards / coding guidelines and leveraging them across the organization at an enterprise level
As designated, ensures a consistent strategy of adverse event and concomitant medication coding across programs and impacted functions
Ensures timely communication of new and/or revised standards. Provides timely feedback to user inquiries
May manage contract staff
20% - Judgment and Decision Making: evaluates immediate business impact and takes decisive action
Maintains currency with changes in the external standards landscape and assists in development of recommendations for actions
Reviews standards deployment strategies and activities at the CRO to ensure optimal benefit for Shire
Keeps current with industry developments and strategies related to standards
As designated assesses and communicates impacts of MedDRA and WHO Drug dictionary updates to Shires Coding guidelines as they are released
As designated, coordinates with IT to manage MedDRA and WHO Drug upgrades
15% - Serving Customers: Partnering with customers as a trusted consultant and becoming an integral part of customer’s decision making
As designated, coordinates with Pharmacovigilence & Risk Management (PVRM) & Physician groups to manage updates to Shire’s Coding Guidelines
Consults within and across Global Clinical Development Operations, and the data management service providers to identify gaps, risks and inefficiencies and works with Standards Team lead on solution development
Ensures overlaps and conflicts are resolved and continuity of “end to end” standards is maintained
Represents Global Clinical Development Operations in cross-functional standards and coding project teams
Collaborates with Global Clinical Development functions to ensure optimal process design leveraging standards infrastructure and scope
15% - Building Authentic Relationships: Building trusting relationships that will enhance current and future needs
Coordinates with Standards Team Lead and peers to prioritize and deliver standards related initiatives
Guides and supports activities of standards management vendors
B.S. degree in Scientific or related field is preferred
Minimum 5-7 years in Data Management/Programming/Statistics or other Clinical Research related fields
Experience with at least one of the CDISC standards
Optionally, exposure to and understanding of MedDRA / WHO Drug coding Dictionaries

Head of Clinical Operational Excellence Resume Examples & Samples

15%
Bachelors Degree required, preferably in a scientific field; MBA or other advanced degree preferred
Minimum of 12 years clinical research experience in pharmaceutical or biotechnology field
Minimum 9 years management experience in clinical research setting
Education, experience and documented results in providing clinical operations support

Clinical Auditor Resume Examples & Samples

Utilizes encoders and various coding resources
Maintains strict patient and physician confidentiality and follows all federal, state and hospital guidelines for release of information
Maintains current working knowledge of ICD-9 coding principles, government regulation, protocols
Ability to travel 10% or less of the work year for training, team meetings, possible onsite audits opportunities and implementation needs
RHIA, RHIT, or CCS credentials
Inpatient auditing experience
3+ years coding experience
Demonstrated ability to exercise solid judgment and discretion in handling and disseminating information
Customer-service focused and exhibit professionalism, flexibility, dependability, desire to learn, commitment to excellence and commitment to profession
Excellent writing, editing, interpersonal, planning, teamwork, and communications skills
Associate's Degree in relevant field preferred
Nurse Coder Background
ICD-10 Trainer certification from AHIMA a plus
Training with inpatient coding

Clinical Guidance Specialist Resume Examples & Samples

Prior Call Center experience
Ability to work 9am to 6pm central time zone; Monday through Friday
Prior Heatlhcare experience with knowledge of billing or pre-authorization approval process

Clinical Messaging Portfolio Consultant Resume Examples & Samples

Develop and implement a robust, dynamic project portfolio management process for the evaluation and prioritization of messaging projects with the ability to influence and drive consensus with both internal and external team members
Lead intake and strategic review of new initiatives to challenge and review submissions, and to provide content, preparation and prioritization of the funding requests for projects by ensuring alignment with organizational objectives
Support development of consumer clinical messaging strategies with clear understanding of the business problem, view of the system, strategic proposals and plans to specific business partners as aligned
Creates and oversee current department processes and recommend new approaches for process improvement and re-engineering to ensure optimal allocation of resources
Manage department budget and resource model
Supports portfolio assessments by working with business leads and consultants to prioritize new and existing projects based on strategic priorities, compliance requirements, and customer demand
Ensures effective performance and status reporting to leadership for all programs and projects within the portfolio
Collaborate and partner with key stakeholders from enterprise messaging, consumer marketing, data analytics and consumer experience teams
Establish and maintain relationships with individuals at various levels of the organization, such as peers, internal/external stakeholders, business partners, and senior level managers
Oversee and maintain departmental process discipline requirements for Internal Quality and Audit
Ability to develop and implement criteria for evaluating projects ability to build project portfolio as well as strategic roadmaps
Experience managing large-scale projects (3-5 years or more)
Experience working with multiple stakeholders to deliver key business goals and objectives
Ability to oversee multiple cross-functional projects simultaneously
Excellent communication and consultation skills
Possess an understanding of business metrics and reporting, communications and processes
Ability to manage budgets and review financial data
Experience using project management tools
Experience in using Microsoft Office and PowerPoint
Experience with operations and technology
Previous experience in healthcare
Experience with Project management/PMP, Process improvement /Six Sigma and Program Management

Clinical Messaging Campaign Management Consultant Resume Examples & Samples

Be the subject matter expert on enterprise campaign management for Proactive Care Strategies
Consult with business partners both inside and outside of Proactive Care on capabilities within campaign management
Partner with other members of Proactive Care, business and IT partners in order to develop the optimal campaign build for the given communication / situation
Providing expertise in the optimization, measuring and monitoring of campaigns
Capitalizing on Next Best Action, Multi-Variant testing and Test/Adjust opportunities
Self-starter and problem solver
Proficient with SQL
Demonstrated ability to function in a consultative capacity
Experience building campaigns in a campaign management system and/or working with CRM solutions (ideally 2+ years)
Campaign Management experience with IBM Campaign (Unica)
Familiarity with Humana core systems
Previous IT development experience
Consumer behavior or direct response marketing experience

Clinical Innovations Specialist Resume Examples & Samples

Knowledge of CGX and CCP2
Excellent both verbal and written communication skills
Associate’s or Bachelor’s Degree in Business
Experience with CIT and CCRT

Internal Audit Clinical Consulting Leader Resume Examples & Samples

Bachelor’s degree in nursing is required. Only candidates with an RN license will be considered
4 to 6 years of process, risk management, consulting or clinical experience
Likes to focus on the "big picture" and thrives in a fast paced, multi-project work environment
Computer literate (MS Word, Power Point, Excel)
Knowledge of Humana’s internal policies and procedures

Clinical Performance Improvement Consultant Resume Examples & Samples

Strong analytic skills and the ability to use data to drive improvement activities
Previous management and operations experience leading teams focusing on operational improvement and performance management
Executive-level communication skills, written and verbal that can be applied to external audiences as well as internal audiences
Excellent PC skills (including MS Word, Access, Excel and PowerPoint)
Strong database software proficiency
Comprehensive knowledge basecrossing all areas within quality and HEDIS programs
Strong analysis and problem solving skills
Strong relationship building and communication skills

Clinical Technical Lead Resume Examples & Samples

Work closely with the Architecture team in understanding the Architecture and the future direction for the application
Work closely with the Development team and provide design specifications that align with the Architecture to deliver on the business requirements
Build a standards-driven, scalable, secure and dynamic portal for managing claims authorizations
Occasionally develop enhancements, resolve issues, coordinate testing of statement releases and oversee regular production efforts
Partner with other business areas within Humana to understand application requirements and develop programming specifications for development staff
Bachelor’s Degree in Computer Science, Information Systems or equivalent experience
Expertise in object-oriented programming concepts, design patterns and service-oriented architecture
Good understanding of web development architecture and design
Strong C#.net programming experience
Experience in the areas of software development and support
Development experience using Visual Studio, ASP, XML, HTML, WCF and SQL
Comprehensive understanding of SDLC, waterfall and/or agile methodologies
Strong experience in web development with C#/.net, MVC
Knowledge of Microsoft Biztalk 2009 or higher
Experience leading a development team (4+ developers)
Health Care Industry experience
UML documentation knowledge

Clinical Audit Consultant Resume Examples & Samples

Process improvement and development experience
Must be able to present to upper leadership
Experience in creating work-flows
Comprehensive knowledge of Microsoft Word, Excel, Visio, Powerpoint and Access
PMI certification

Client Strategist Clinical Rules Portfolio Resume Examples & Samples

Manage multiple, complex initiatives, developing successful partnerships with a strong customer focus
Provide clinical subject matter expertise in consultation with clients and leverage voice of the customer to help shape the development of population health tools and services
Engage clients to demonstrate the value of our population health, clinical analytics, interoperability tools and services and advocate for adoption with clinical workflows
Leverage a deep understanding of market conditions and client needs to plan the clinical rules roadmap and ensure existing rule assets are renewed to stay current with clinical specifications
Partner with clients to ensure that the value proposition of deployed solutions is being realized
Experience in a clinical setting (hospital, primary care, specialty, etc.)
Working knowledge of clinical data types and data sources (Claims, Rx, Labs, CCD, etc.) and data standards (CDISC)
Knowledge of clinical quality measures (CQM) and industry standard measure sets such as HEDIS, Stars, ACO, or MU
Understanding of industry regulation and familiarity with accrediting agencies and government agencies (NCQA, NQF, CMS, etc.)
Minimum of a Bachelor's Degree (B.S or B.A) in nursing, biological sciences or related discipline
Understanding of MSO and ACO risk relationships, shared savings, and delivery networks
Experience with Medicare, Medicare Advantage, and Medicaid regulatory and quality requirements
Experience with electronic medical records (EMR), health information exchanges (HIE), health information technology (HIT)
Experience working within a dynamic startup or software product company in health information technology or related industry
Advanced degree (M.S., Nurse Practitioner, MPH or Ph.D.) or licensor/certification (CCM, APRN) is a plus

Sun Quest Clinical Application Analyst Resume Examples & Samples

Participate as a team member in supporting the various aspects of healthcare Clinical workflow processes such as OE, Lab, Radiology, OR, ER and query report writing as well as ancillary departmental systems
Provide laboratory application technical support for multiple sites
Responsible for the execution of projects and enhancements within clinical environment to support the business needs of the departments
Provide level 2 support in response to user problems and questions regarding functionality, operations, input/output, reporting and general operating procedures
Perform modifications and/or enhancements to systems including changes to profiles, master files, reports, screens, systems design, conversion requirements and documentation requirements
Provide/recommend innovative ideas, processes and/or procedures for enhancements, additions, modifications to improve the existing systems
Perform specific work relevant to the service delivery area that meets/exceeds key performance criteria, SLAs and customer expectations
Prepare status reports for assigned projects
Perform troubleshooting and analysis
Analyze business and regulatory requirements and applies these requirements to systems programming
Create/modify queries and reports
Work on a variable, rotating on-call duty
Undergraduate degree and 0-2 years of relevance experience
2+ years of clinical application experience in the healthcare environment
Strong analytical and communication skills
Knowledge of clinical and ancillary departmental systems, query report writing and integration and system implementation skills
Experience with SunQuest Laboratory, McKesson HRM Radiology, Clinicomp Labor and Delivery, Radiology, Medical Records and other ancillary systems

Clinical Systems & Technologies Lead Resume Examples & Samples

40% - Delivering Excellence: Takes Leadership Roles in Projects and Project Implementations
25% - Leading and Managing
8+ years experience in Data Management, Clinical IT, or other Clinical Research related fields

Clinical Audit Analyst Resume Examples & Samples

Proficient knowledge of Microsoft Word, Excel
Microsoft Access (having the ability to create a query and launch theoretical claims in the system)
Process documentation and workflows
Strong analytic skills
Strong written and verbal communication Skills
Self-Starter—high level of initiative
Works well with ambiguity
MTV and/or CAS Platform experience
Proficient in Microsoft Visio, PowerPoint

Clinical Innovations Specialist Peoria Resume Examples & Samples

Professional appearance and attitude
Proficiency in Microsoft Office Word and Excel
Previous healthcare or health insurance experience preferred

Metrician Clinical Intelligence & Analytics Resume Examples & Samples

Bachelor’s Degree in Math, Statistics, Economics or a related field
Prior statistical experience
Ability to communicate statistical and technical concepts in a manner that is easy to comprehend
Experience using SQL and/or SAS
Graduate Degree in Applied Mathematics or Statistics
Experience with large data sets and/or the analysis of patient-level healthcare data
Experience with propensity score matching techniques and ROI analysis
SAS programming certification

Frontline Leader, Non-clinical Specialists Resume Examples & Samples

Administrative experience in call center environment
Prior experience in supervisor or mentor/SME capacity
Valid drivers license and/or dependable transportation necessary
BSN or Bachelors degree in a related field

Clinical Reimbursement Manager Resume Examples & Samples

Bachelor of Science in Nursing required
MDS and PRI experience required
RACC certification preferred
Long term care experience required, preferably within a CHHA
Knowledge of Medicaid and Medicare

Clinical Sample Coordinator Resume Examples & Samples

Certification as a Medical Laboratory Technologist, MLT (ASCP) or CLS (ASCP) preferred
Experience working in a biomedical or clinical research organization
Experience in procuring and managing bio-specimens and automated specimen processing
Experience in core facility operations and laboratory information management systems
Exposure to database platforms and programs preferred

Clinical Performance Improvement Consultant Resume Examples & Samples

Bachelors degree in a health related field and/or business or work equivalent experience
Proven track record in provider education, performance improvement/Quality Improvement work in health- with associated professional degree
Experience in completing efficient health-related research, with associated analysis and conclusions
Previous operations experience coordinating teams focusing on operational improvement and performance management
Comprehensive knowledge base crossing all areas within quality and HEDIS programs
Certified Coder/Coding Educator is highly desirable

SVP & GM, Clinical Reference & Workflow Resume Examples & Samples

Manage a team of 50+ FTEs and be responsible for more than $150m of revenue
Create the product/portfolio vision and manage the entire product life cycle
Own, champion and manage the development and execution of product/portfolio business plans that solve customer needs
Seek new market opportunities within the company's distinctive competence
Develop and manage the portfolio budget
Specify market requirements for current and future products by conducting market research supported by on-going visits to customers and non-customers
Work and ensure tight alignment with key stakeholders including Sales, Business Development, and Marketing to develop go to market strategies, sales and usage targets, pricing, packaging, etc
Analyze and identify potential partner relationships and acquisition candidates for the product and channel
Continuously monitor market and competitor trends and develop plans to proactively address
Measure, monitor, and report the success of the solution based on defined goals
Develop and refine action plans to ensure success
Represent Elsevier and evangelize, both internally and externally, the product offering
Drive a solution set across development teams (primarily Development/Engineering, and Product Marketing and Customer Marketing) through market requirements, product contract, and positioning
Interface with internal customers (IT, Production, Operations Groups) to ensure the needs of the business are understood and incorporated into the vision
Minimum of 10+ years in healthcare market
Experience in managing cross-functional teams a plus
Experience in product development and workflow solutions
University degree and MBA required
Strong strategic perspective and driving results
Experience in marketing, business development and developing and launching new products is critical
Entrepreneurial skills and good in starting up new initiatives

Clinical Guidance Specialist Resume Examples & Samples

Excellent oral and written communications skills in both English & Spanish
Proficiency in Microsoft Office applications, including Word, Excel and Power Point
Previous inbound call center experience
Knowledge in Medical Terminology (ICD-9, CPT, HCPC's)

Clinical Interoperability Process Consultant Resume Examples & Samples

Identify and resolve barriers to performance from determining root cause analysis, creating process mapping and resolution – implementation
Oversee the improvement process
Ensure standardization of processes within and between all service centers
Promote the implementation of best practices
Prior demonstrated experience with process improvement or process design and implementation roles
Comprehensive knowledge of all Microsoft Office applications, including Word, Project and Visio
EMR subject matter expertise
Provider facing experience
Must be able to travel a minimum of 25% and maximum of 100%
Epic subject matter expertise and willingness to learn other EMR’s as needed
Clinical Degree

Clinical Guidance Consultant Resume Examples & Samples

Associates or Bachelor’s in Nursing (RN or LPN)
Active LPN/RN in state of residence and can work without restrictions
Certified Professional Coder (CPC)

Clinical Metrics Analyst Resume Examples & Samples

Design, development, and deliver of operational reports, dashboards, and adhoc requests
Develop and establish strong and effective working relationships with clinical program leadership and other departments
Derive observations and insights from metrics to support and improve clinical operations
Bachelor’s Degree in Business, Information Technology, Mathematics, or equivalent work experience
2 to 3 years or more of reporting experience
Must have the following experience with Microsoft Access: building tables and querying tables
Must have the following experience in Microsoft Excel: build pivot tables, GETPIVOTDATA function, math functions, VLOOKUP, and building graphs
Ability to interview business owners to define the need/problem/desire of a request and understand how best to fill the request to drive value
SQL/SAS knowledge a plus
Strong problem solving and troubleshooting skills, especially around data acquisition, transforming data into information, and delivering information effectively
Assist team consultants and business leaders in understanding the “story” contained within or behind the data/report
Ability to see trends and provide advice regarding root cause(s) of any trend (positive and negative)
High collaboration and consensus building skills (assuring that reports align with stated operational goals and/or strategy initiatives)

Clinical Innovations Analyst Resume Examples & Samples

Builds Trust: Consistently models and inspires high levels of integrity, lives up to commitments, and takes responsibility for the impact of one's actions
Collaborates: Engages others by gathering multiple views and being open to diverse perspectives, focusing on a shared purpose that puts Humana's overall success first
Customer Focus: Connects meaningfully with internal customers to build emotional engagement and internal customer advocacy. Simplifies complexity and integrates internal efforts to deliver an optimal customer experience
Work with business users to define and document requirements for analytics projects
Develop analyses, on-demand reports, and scheduled reports using database queries and business intelligence tools
Facilitate communication between business users and IT partners
Prior experience working in healthcare system analytics and/or data warehousing environment
Advanced SQL knowledge
Advanced degree in Business, Engineering, Math, Statistics, Health Administration, Public Health, Finance or other health related field preferred
Prior experience using Base SAS or SAS EG

Clinical Auditor Resume Examples & Samples

Certified Medical Coder with at least one of the following credentials: CPC, CCS, RHIA, RHIT
3+ years prior coding experience and outpatient auditing experience
Proven proficiency across a wide range of services, which include evaluation and management, anesthesia, surgical services, radiology, pathology and medicine
Strong written and verbal communication skills; strong analytical, organizational and time management skills

Market Clinical Strategies Analytics Manager Resume Examples & Samples

Identify gaps in current reporting abilities or packages and pursue enhancement opportunities for new or established reporting packages
Utilize Clinical Datamart knowledge to identify and communicate system related enhancements to key stakeholders within Humana’s managed care departments
Bachelor’s degree in Business or Information Technology or related field
Minimum two years of experience with SQL reporting (SQL Server Enterprise Manager, SQL Server Management Studio, etc)
Minimum two years of experience with health care data reporting
Proven experience analyzing very large data sets
Proven experience developing metrics to track large programs
Proven experience presenting outcomes and data to executive team
Strong organizational and multi-tasking skills required
Previous experience with Humana clinical systems (i.e. CCA, CCP2, CGX, Atlas/QSM)

Clinical Auditor Resume Examples & Samples

Performs Verint validation reviews
Utilizes audit tool
Conducts reviews to ensure compliance with guidelines and provides reports to manager/leader as directed
Maintains strict patient health information confidentiality and follows all federal and state guidelines
Maintains current working knowledge, principles, government regulation, protocols
An RN with an active nursing license
At least 3-5 years nursing experience
Computer proficient with MS Office products including; Excel, Word and Outlook
Prior auditing experience
Previous experience working in a skilled nursing facility (SNF)
Prior experience in SNF review

Clinical Need Intern Resume Examples & Samples

Understand current status of research and development in the laboratory
Work closely with the team of engineers and researchers to assess and prioritize clinical unmet needs
Review medical and scientific literature to draft a clinical need statement
Review market research and competitive landscape to evaluate business opportunities and define value proposition for innovative medical technology
Educate colleagues about human anatomy and current clinical practice for relevant technology areas
Education: Current medical student, preferably in the final years of the joint MD/MBA program

Proactive Clinical Strategies Director Resume Examples & Samples

Bachelor’s Degree in Business, Marketing and Communications or a related field
Prior work experience in the health solutions industry with demonstrated success directing and leading teams
Experience creating strategy and executing the strategy to achieve the business goal
Experience working with internal and external partners
Proficiency in analyzing and interpreting trends
7 years or more of professional experience
Comprehensive knowledge of all Microsoft Office applications, including Word, Excel and PowerPoint
Demonstrated success in large scale collaborative efforts
Customer Service or Member Experience background
Marketing or member communications background
Experience working with Voice Activated Technology vendors and/or call centers

Clinical Specialst San Juan Resume Examples & Samples

Capacity to manage multiple tasks
Excellent oral and written communications skills in Spanish
Ability to work under tight schedule and under pressure
Excellent oral and written communications skills in English

Clinical Document Manager Resume Examples & Samples

6+ years in the pharmaceutical, biotechnology or medical device industry with at least 3 years of experience in Clinical Trial Master File management
Demonstrates thorough knowledge and understanding of regulatory authorities, GCPs, ICH guidelines and regulatory requirements for TMFs
Demonstrates a high level of knowledge of clinical operations’ methodologies and organizational capabilities
Strong record of delivering process improvement projects
Strong verbal, written, presentation and interpersonal skills
Additional experience in GCP Quality Assurance
Knowledge of eTMF systems

HPS Clinical Formulary Management Analyst Resume Examples & Samples

Builds new formularies and drug lists in Humana’s formulary management system
Performs weekly maintenance and updates of formularies and drug lists
Completes formulary submissions to Medicare and Commercial Plans
Becomes an expert in Humana’s formulary management system and prescription drug data
Performs extensive formulary analysis and reporting
Partners with pharmacists, healthcare professionals and operations staff in a team environment
Develops appropriate analysis and metrics to deliver process improvements and business results
Creates documented processes and training materials
Excellent data analysis and experience working with MS Access and Excel
Knowledge/experience working with SQL (via MS SQL Server, Oracle, PL/SQL or other)
Three years’ experience in a health services or technical field
Pharmacy or pharmaceutical related background
Familiarity with MS Word and Visio

Clinical Audit Supervisor Resume Examples & Samples

Bachelor’s Degree in nursing
Five years varied clinical experience
Two years of management experience
One year managed care experience
Registered Nurse with current in-state RN license
UM or Case Management Certification
Interqual knowledge
Microsoft Access knowledge

Market Clinical Strategies Process Consultant Resume Examples & Samples

Model business consultation capabilities to align required needs with executable business solutions
Act as subject matter expert for Corporate Clinical Strategies Internal and External customers
Will manage oversight for Corporate Medicare Clinical Strategies programs: design, implementation, measurement and evaluation with internal customers, such as Provider operations. Humana Cares, and Regional Medicare Markets
Experience in leading health care initiatives
Progressive business consulting experience
Experience with process design and process improvement
MBA/MHA desirable
Business Development skills for Health Care Operations
Proven Track record with business development design/implementation

Market Clinical Strategies Process Consultant Resume Examples & Samples

Provide process management support for HGO Clinical teams assigned to the Medicare markets
Provides support for business plan and long range forecasting model production by developing custom tools and reports
Develop a thorough understanding of Managed Care practices and procedures from a Medical Management perspective
Develop and maintain key working relationships across all HSO regions, HGO Corporate team and other departments to ensure consistent data tracking and reporting
Further the HGO’s vision for continuous improvement by assisting in identifying best practices in Humana’s Medicare Regions and formulating proposed solutions to address identified barriers
Identify and communicate system related enhancements to key stakeholders within Humana’s managed care departments
Bachelor's Degree in business related field
High level proficiency with Microsoft Office applications, including Visio
Excellent communication skills, written and verbal
Self-starter with a high level of accountability and a strong desire to excel in a fast-paced, high-demand environment
Previous health insurance industry experience working
Six Sigma Green Belt
Qlikview experience
Previous experience with Measurement Development

Clinical Programs Lead Resume Examples & Samples

50% Oversight with an emphasis on strategic planning, implementation and execution of relevant team and work stream plans for therapeutic indication(s) or company initiatives in keeping with corporate and department goals
Assess decisions from other functions and their impact on team and work stream plans
Provide updates and direction to Sr. Management when conflicts, key developments and program scope/ direction changes are identified
Work cross functionally to drive the strategy and oversee implementation for clinical programs or company initiatives
Identify and evaluate fundamental issues with multiple variables for major functional areas, and provides solutions and direction
Ensure document and operating standards are established and maintained locally and globally
Oversee selection of study sites and vendors
Participate in/ or lead cross-functional teams at corporate or global level
20% Responsible for the creation and management of budget & forecast for specified therapeutic areas or company initiative
Overall responsibility for assigned clinical program budget(s) and LRP planning and implantation
Oversee budget activities
20% Align skills and resources needed for success; work closely with internal and external stakeholders to leverage and optimize resources
Review and evaluate resource needs and influence for appropriate prioritization of clinical programs
Provide general direction to cross functional team representatives, as needed
Oversee management of sites and vendors to issuer resolution if necessary
Oversee identification, qualification and selection of CROs and vendors needed to conduct clinical trials and other relevant out-sourced activities including approval of Master Services Agreements and Task Orders with CRO
Align with team members from other functional arears regarding planning, implementation, tracking, analysis, and reporting of milestones
5% Participate in business development and process improvement activities as needed
Under direction of Sr. Management, participate in due diligence activities
Establish/ identify the initiatives that will be targeted for improvement/ revision locally and globally
Participate in the development of corporate or organizational policies and authorizes the implementation
5% Participation in Research and Development, a department and/ or corporate wide task forces as appropriate

Clinical Guidance Specialist Resume Examples & Samples

Make outbound calls to providers in order to coordinate reviews/scanning of medical records of our Medicare Advantage members
Document all appointments scheduled and sending of fax
Assist the department with various clerical and administrative tasks
Assist in special projects as assigned by the department manager
Proficiency in Microsoft Office applications Word, Excel and Powerpoint
Puerto Rico Driver’s license
Reliable transportation
Ability to travel the island
Associate in a health related field

Clinical Global Development Team Lead Resume Examples & Samples

Lead the multidisciplinary Global Development Team(s) (GDT) and, if applicable, closely collaborate with the Product Strategy Team (PST) and the Product Strategy Team Lead (PSTL) to provide and execute strategic development plans to rapidly address key unmet medical needs and meet the strategic imperatives of the appropriate business unit (BU)
Matrix management of GDT members
Ensure all clinical documents have proper accuracy content,, CSR’s, Regulatory Documents, as the individual is ultimately responsible for overall strategy, tactics, and deliverables for the program
May lead one or two less complex development programs, and broadly contribute to strategic thinking at the Therapeutic Area level
Engagement and communication across business units and functional lines, including impact on strategic thinking at the Development Steering Committee (DSC) and the Pipeline Committee (PLC)
Partnership with Program Management (PM) representative on the GDT to ensure consistent high quality output from the team, and engagement with PM with regard to exploring opportunities to enhance speed and/or project value
Overall Development Strategy and Plan
Accurate and effective budget management for Development Programs, addressing issues as they arise
Assessment of Business Development opportunities which could impact on Development Programs, monitoring external scientific information and competitor activity related to Development Programs and modifying program strategy as appropriate
Tracking progress against project goals and composing monthly reports for senior management and Shire Leadership teams outlining key strategic events for projects. These documents contain program milestones, strategic imperatives, and financial information regarding projects
Responsibilities likely to include postmarketing commitments and lifecycle management initiatives
As an experienced Clinical Development professional, take a hands-on role in establishing a detailed clinical development plan, possibly working with a less experienced Clinical representative on the team
Be a lead clinical representative at key external business meetings (e.g. with regulatory authorities) and if appropriate, a presenter at regulatory Advisory Committee meetings
Line management and/or mentorship of less experienced GDTLs and/or Clinical research staff on GPTs
Be key point of contact for external key opinion leaders, and potentially media
M.D. preferred, or PhD, with experience managing Clinical Development projects in pharmaceutical or biotech company. Experience in small and large pharma and in different business models preferred
>8 years experience in the pharmaceutical/biotechnology industry
Experience of drug development in the TA where the position is focused, rare diseases, neuroscience, GI, or hematology would be preferred
Knowledge and understanding of regulatory requirements for product approval and compliance in US and Europe, experienced in global drug development
Aware of changing trends in pharmaceutical drug development, and experience in applying new approaches
Experience of team leadership in a matrix management environment
Experience with drugs at all stages of Clinical Development and presenting data to regulatory agencies/Advisory Committees. Experience in taking drugs to market preferred
Experience in modifying project plans and defining creative solutions to meet business needs
Troubleshooting and solving problems under very challenging timelines while maintaining standards of quality
Experience as an effective mentor. Line management experience preferred

Consultant for Clinical Audits Resume Examples & Samples

Maintains current working knowledge of ICD-9 and ICD-10 coding principles, government regulation, protocols
RHIA or RHIT or CCS credentials
3+ years Acute Inpatient Hospital Coding experience
Demonstrated ability to lead process/project initiatives
MS Office proficient
Proficient 3M Coding and Reimbursement Systems
Preferred coding skills: prospective payment methodologies, auditing experience

Clinical Programs Lead Resume Examples & Samples

Expected to resolve and/or escalate issues raised by assigned GCOL(s)
Collaborates with project physician, statistician and relevant functional areas on clinical trial designs
May attend advisory panel meetings and regulatory agency meetings related to strategy of program, indication, and studies
Presents program overviews/status to senior management, cross functional team, and external partners as necessary
Significant experience (10+ years) of clinical research and organizational management within the pharmaceutical industry, a CRO or similar organization
Demonstrated ability to present complex information to Shire management, vendors and external audiences
Ability to manage and communicate effectively with vendors including negotiating contracts, reviewing request for proposals, analyzing scope of work, responding to inquiries and complaints
Strong interpersonal skill set necessary to create and maintain internal and external collaborator relationships. Strong attention to detail and the ability to establish priorities for team
Aability to work independently, take initiative, complete tasks to deadlines and support assigned GCOLs in doing the same
Ability to work and influence others within a cross-functional team
Demonstrated ability to lead, motivate and mentor staff and teams
Develops project-plan(s) to achieve long-term goals based on higher business level drivers and strategies
Ability to work effectively wihtin a cross functional team
Demonstrated ability to create and manage 1 more program budgets including communication of overspend/underspend risk and mitigation efforts
Ability to communicate and influence key internal and external stakeholders to insure success while looking for opportunities for collaboration
Proven ability to removes barriers to success
Demonstrated ability to respectifully challenge current practices, decision or ideas to uphold quality or ethical standards
A demonstrated knowledge of the skills needed to deliver effective line management

HPS Clinical Formulary Management Analyst Resume Examples & Samples

Bachelor’s degree or several years of experience in a healthcare profession
Excellent data analysis and experience working with MS Excel
Familiarity with MS Access, Word and Visio

Mckesson Horizon Clinical Application Analysts Resume Examples & Samples

Horizon Expert Orders (HEO)
Horizon Order Management (HOM)
Horizon Emergency Care (HEC)
Horizon Clinicals Infrastructure (HCI)
Horizon Expert Documentation (HED)
Horizon Expert Notes
Horizon Expert Plans
Horizon Meds Manager
Admin RX

Clinical Innovation Consultant Resume Examples & Samples

Bachelor’s or Master’s Degree in Health Education
Current Bachelor’s or Master’s valid license
Proven successful experience in completing efficient research, with associated analysis and conclusions
Excellent PC skills (including MS Word, Excel, Publisher and Power Point) required
Excellent oral presentation, written communication and organizational skills required
Ability to travel Puerto Rico Island and Virgin Island
Personal car in good conditions and valid license
Team player, ability to work with tight schedules, extended hours, weekends, night shifts and multiples priorities
Ability to develop wellness programs, health conference, client presentations and experience in the health promotion impacting communities or diverse population
Bilingual
Master’s Degree in Public Health Education
Certified Health Education Specialist (CHES)
Certified Childbirth Educator
Certified Lactation Consultant or Certified Lactation Educator
Experience in managed care or health insurance setting desired
Experience in CCMS and SPSS Programs

Clinical Document Specialist Resume Examples & Samples

Responsible for high quality clinical document deliverables across multiple, global assigned studies in support of CDO ensuring effective life cycle management of the clinical section of the Trial Master File (TMF)
Key contributor to the clinical study team
Monitors completeness and quality of the Clinical TMF, including elements outsourced to CRO
Oversees consolidation and archive preparation of clinical TMF, liaising with CRO partners to ensure compliance with company SOPs and timelines throughout the process
Ensures compilation of CSR appendices in accordance with Shire’s process
Collaborates with R&D contributors to define study specific TMF roadmap. Oversees the consolidation of the TMF across functions and external vendors at the end of the study
Supports inspection readiness for GCDO through periodic quality assessment of clinical records
Supports assigned TMF corrective action plans under direction of Snr CDT/Manager
Supports CDT led initiatives to enhance efficiencies in document management
Supports Managers in training efforts for new personnel
Demonstrated ability to be flexible and to adapt quickly to change

Clinical Guidance Specialist San Juan Resume Examples & Samples

Receive inbound calls to the providers in order to coordinate the pre authorization/discharge planning or concurrent review process
Work with providers to maintain updated of the pre authorization/discharge planning or concurrent review process
Work with the Clinical Advisor RN and support the pre authorization/discharge planning or concurrent review process
Complete provider outreach within specified timeframes to obtain standard patient clinical information for all patients identified for review, per program workflow and protocols
Complete updates to letters using the letters templates to support nurses and clinical leadership in sending the proper, timely correspondence to patients and providers
Complete required documentation and perform other responsibilities as necessary
Ability to quickly learn new systems
Proficiency in Microsoft Office applications Word, Excel and PowerPoint
Ability to work independently under general instructions
Good presentation and communication skills
Associate/University Degree

Clinical Strategies Analytics Consultant Resume Examples & Samples

Develop skills needed to access data from various internal systems and reports
Work closely with business subject matter experts to compile and track managed care metrics
Develop methods and criteria for summarizing metrics into appropriate reporting format
Communicate and lead strategy discussions across various departments around Medicare operational reporting
Complete special projects as needed
Advanced Microsoft Access skills
Clear written and oral communications skills
Previous experience with Medicare line of business preferred
Experience in using SAS, SPSS or Oracle preferred
Building dashboards using Qlikview
Ability to Reverse-Engineer a report in order to understand the process
Advanced SQL skills including the use of temp tables, data aggregation, linking multiple source tables, working with star-schema, synonyms and views

Clinical Auditor Resume Examples & Samples

Bilingual – English/Spanish
3 or more years’ experience in the health industry, to include knowledge of CPT code billing
At least one year of continuous service in current role

Clinical Technical Lead Resume Examples & Samples

Develop an understanding of Humana’s business needs and translate those needs into technological systems, design specifications and solutions
Partner with other associates to analyze, design, develop, implement and integrate moderate and complex business systems that will optimize business outcomes
Bachelor’s Degree in Computer Science, Information Systems or equivalent experience (minimum of 3-5 years of experience)

Clinical Medicare Case Manager Resume Examples & Samples

Recommend services for Humana Plan members using care alternatives available within the community and nationally
Examine clinical programs information to: manage our members on an outpatient basis and develop strategies to prevent readmission; mine health risk assessment data reports to identify potentially high-risk membership; identify and refer members to Disease Management Programs; conduct discharge planning; coordinate Behavioral Health management
Coordinate: in versus out-of-network movement; care in out-of-network facilities; care with specialty networks; care with DME providers; transfers to SNF and back
Conduct post-discharge calls and discharge planning
Current RN or LMSW or LCSW license
2-5 clinical experience preferably in an acute care, skilled or rehabilitation clinical setting
Valid drivers license and/or dependable transportation necessary (variable)
Special Certifications: Case Management Certification
Health Plan experience Previous Case Management experience
Medicaid/Medicare experience

Clinical Programs Lead Resume Examples & Samples

Provides functional input into the clinical development plan that aligns with Business Unit and product strategy
Provides strategic clinical programs input to Global Development Team (GDT) and Product Strategy Team (PST) as required
Presents program/study(ies) overviews/status to senior management, cross functional team, and external partners as necessary
30% Oversees or is responsible for
Program and /or study level document generation (e.g., synopses, ICFs, submission modules)
Presentations at relevant internal and external meetings
Alignment of program for cross functional team regarding execution
Reporting of program / study milestones including mitigation
Works closely with Global Development Team Lead (GDTL), finance business partner, and/or study team(s) to generate and review forecasts and accruals for clinical studies
Ensures clinical program/study(ies) finances align with agreed development plan, and budget variances are escalated to management as appropriate
May assess long-range resource needs and make recommendations and allocations across program(s)
Mentors junior staff
May be involved in interviewing, hiring, and training employees
Provides feedback on employee performance
Promotes Clinical Programs achievements within and across department(s)
Reviews and contributes to strategy for operational efficiency
Collaborates on SOP development
Ensures implementation and standardized use of Global Clinical Development Operations (GCDO) and/or other R&D tools.

Clinical Trial Budget Analyst Resume Examples & Samples

Interacts with faculty, University offices and external funding agencies to facilitate the exchange of information and provide services associated with pre and post-award administration of contracts and grants to assigned department(s)
Acts as University representative to sponsoring agencies
Resolves pre and post-award administrative problems related to sponsored projects
Provides post-award administrative support including expenditure approvals, accounting detail and reporting requirement information. Monitors for allowability on contracts, submits interim reports, and reviews and approves closeout documents
Advises on specific agency requirements and guidelines to assist faculty in the preparation and submission of proposals
Composes and procedures a variety of business correspondence, reports, confidential documents and/or forms, and related materials or guides the work of other staff who produce these, materials. Reviews and signs, as authorized
Ensures confidentiality and controls access to sensitive information such as faculty or staff personal files
Assist in budget preparation by gathering historical data. Tracks and monitors assigned budget expenditures and/or special actions and reports on variances

Clinical Scientific Expert Resume Examples & Samples

Advanced Degree in Life sciences, Healthcare or a Clinically relevant field
Basic knowledge in planning, executing, reporting and publishing global clinical studies in a Pharmaceutical company or contract research organization
Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and clinical development process
Exceptional Medical / Scientific Writing skills
Experience in Clinical Operations

Clinical Business Process Analyst Resume Examples & Samples

Technical experience in a Pharmaceutical or Clinical environment
Familiarity with associated tools such as Informatica Data Quality, JIRA ticket system and others
Experience in testing and validation system enhancements and bug fixes; responsible for associated documentation
Experience in identifying report issues and ability to troubleshoot and fix
Experience leading workgroups to gather business requirements
Solid analytical thinking skills
Prior experience managing clinical data within a Clinical Trials Management Systems
Experience working with Research & Development, especially Clinical Research & Development

Clinical Innovations Consultant Resume Examples & Samples

Bachelor Degree in health or relevant working experience
Experience with utilization management of Medicare and/or Medicaid population/plans
Proven successful experience in completing efficient health-related legal, compliance or regulatory research, with associated analysis and conclusions
Experience with Medicare and Medicaid compliance and regulatory requirements
Registered Nurse with at least 3 years clinical experience with Medicare and Medicaid populations
Master’s degree in health- or business-related field

Clinical Audit Analyst Resume Examples & Samples

Likes to focus on the “big picture” and thrives in a fast paced work environment
Able to work interactively with internal and external business partners
Self – starter and problem solver
Intermediate knowledge of Microsoft Word, Excel, PowerPoint
Ability to utilize analytical thinking in determining root cause
Exhibit high level of emotional intelligence
MS Access reporting experience
Knowledge of CAS and or MTV claims system including processes and adjustment experience

Stars Clinical Task Force Data Analyst Resume Examples & Samples

Analyze and monitor production data in comparison with aggregate and contract goals
Analyze data to "Tell the story"; identity trends and key areas of improvements for clinical Stars measures
Develop timely clinical measure reporting
Compile geographical and contract level insights to inform initiative planning and/or revisions
Manage special projects supporting Stars Clinical Taskforce initiatives
Maintain Stars process discipline from Clinical Task Force team (manage SharePoint, maintain project plans, update initiative briefs, etc.)
Maintain strong working relationship with internal stakeholders
Plan all Stars related events including quarterly Stars Planning Meetings
Coordinate Task Force Tuesday meetings
Comprehensive knowledge of all Microsoft Office applications such as Microsoft Word & PowerPoint
Must be able to do the following in Excel: Must be able to analyze large data sets
Excellent communication skills due to high exposure across Humana
Experience interpreting and leveraging data in effective decision making
Ability to self-motivate and provide self-direction/self-starter
Ability to do the following in Access: Must be able to run complex queries in Access, such as Cross Tab Queries and Query Joins
Experience with database queries
Prior work experience in the healthcare industry
Process mapping and process management experience
Visio / Process Mapping

Clinical Modeling Consultant Resume Examples & Samples

Degree in mathematics, biostatistics, computer science, engineering, public health or equivalent work experience
3-5 years of coursework and/or commensurate professional experience with analysis and outcomes
3-5 years of experience using technical and analytical tools (e.g. SAS/SQL) to manipulate and draw insights from large, complex data sets
Previous experience creating a research/analytical plan, completing in-depth analysis on large data sets, and communicating the outcomes or findings to others
Clear verbal and written communication with the ability to communicate analytical data and insights to a wide variety of consumers
Ability to work efficiently to manage multiple competing projects and initiatives
Flexible, dynamic personality who works well in a team environment and is also an individual contributor
Masters’ degree in health services research, statistics, quantitative social science or related analytical focused field
Advanced understanding of medical claims data including the use of medical coding to identify relevant populations based on clinical criteria
Experience reporting on the healthcare utilization patterns of discrete populations from claims data
Project management experience or demonstrated skills managing large projects and pulling together multiple resources
Understanding of managed care data, benefit design and how it applies to clinical research
Experience in forecasting and predictive modeling techniques

Clinical Assessment Developer Resume Examples & Samples

Participate in developing and refining test items and working with the Research Director and others on test content and format
Develops item art specifications and works with the Design, UX, and Production teams to ensure that visual and verbal item stimuli meet both print and software specifications and usability standards
Conducts literature reviews, compiles references, and collects supporting face pages
Responsible for preparation of scoring materials, training scorers to accurately score test protocols, monitoring the accuracy of the scorers’ work, and retraining if necessary
Executes different research phases of the project which may include finalizing record forms, stimulus books, and manuals, writing chapters of the final manual using standard text templates, providing necessary content information for scoring and reporting software programs, and checking for consistency across different components of the test
Works with the project team to ensure that all test kit materials and deliverables, both in print and digital mediums, are prepared in a timely manner to meet the publication schedule
Masters in School Psychology, or PhD or PsyD in clinical, counseling, or school psychology
Must have demonstrable expertise, training, and clinical experience in the area of psychological assessment, as well as interest in applying aforementioned expertise, experience, and skills to the development of published print and digital clinical assessments
Must have a minimum of 1 year clinical/educational/research experience involving administration and interpretation, and/or development of clinical assessment instruments
Must have strong oral and written communication skills, good planning and organizational skills, interest and training and/or basic graduate level skills in research methods and statistics, ability to work as part of a team, flexibility, and desire to learn the test development and publishing process
Good familiarity with basic computer software programs (e.g., Word, Excel) and the ability to use or learn digital communication tools such as video conferencing
Subject Matter Expertise:Expertise in psychological assessment, training and/or experience in research, and practical experience in both psychological testing and intervention
Teamwork: ability to work collaboratively as part of a multidisciplinary project team with software engineers, designers, user experience experts, editors, marketing professionals, etc
Critical Thinking: ability to recognize assumptions, evaluate arguments, and draw conclusions that are clear, consistent, sound, and fair and result in positive outcomes for the business
Comfortable with technology in business, with experience, skills, and/or demonstrated ability to utilize and/or teach others to utilize technology, mobile and web applications, and software in everyday life and in business
Experience creating an app or prototype
Experience creating digital assessment tasks or games
Experience conducting research with digital tests or games
Basic knowledge of XML or HTML

Epic Certified Clinical Specialty & Ancillary Analyst Resume Examples & Samples

Current Certification in one or more of the areas listed above with at least 1 year of hands on build experience
Actively participated in all phases of the Epic deployment process (Design, Build, Validate, Implement, and Optimization)
Will be responsible for managing and leading automated system projects through all phases of the system development life cycle. This includes design, development, implementation, modification, planning, estimating, feasibility testing and evaluation of automated systems
Will make recommendations and provide input to the Client concerning software evaluations
Provide best solutions to identified needs, meeting operational and business objectives, and technology capabilities
Maintain the ongoing service relationships between the Information Technology Department and its direct application customers, and is a liaison to other departments and entities
Will provide after-hours support and other duties as directed by Client
This position supports one or more Epic module/tool/add-on system. The Analyst will take the lead role in the project planning, design, build, implementation and ongoing support for the new Epic use at the client facility or facilities
Both clinical workflow and technical build experience required
Bachelor’s Degree preferred or equivalent professional experience
1 - 3 years relevant healthcare information systems experience required
Strong knowledge of project management methodologies and experience managing multiple projects

Clinical & Technical Specialist Mena Resume Examples & Samples

Maintains open and effective communication with all personnel, customers and other Company employees
Contributes to the completion of milestones associated with specific projects at the regional level
Ensure personal understanding of all quality policy/system items that are personally applicable. Follow all work/quality procedures to ensure quality system compliance and high quality work

Clinical Trial Transparency Lead Resume Examples & Samples

50%:Assists Team Lead in Internal and External Transparency and Data Sharing Projects and Strategic Transparency Initiatives
To develop a sustainable, end-to-end process to fulfill Shire’s commitment to responsible and ethical approach to trial disclosure and transparency across the organization
Supports and Consults with internal core team and/or sub-teams on strategic transparency initiatives
Provides compliance expertise and technical guidance to internal staff and senior management on an ongoing basis
Maintain awareness of changes in the Transparency landscape, including both regulatory requirements and industry trends
Assesses impact, identifies action required, and communicates needs to CTT management
Collaborates with CTT team to ensure a firm understanding of the activities affecting transparency
Assists CTT Team Lead in external initiatives to represent the company position in support of transparency activity and development of industry standards
Develops materials targeted to various internal and external audiences to communicate the overall Transparency/Data Sharing Strategy
Creates Training materials and presentations for key functional areas and at all levels of the organization
Proposes and assists in activities that support evolving strategy for clinical trial transparency
40%: Process and System Development
Supports the CTT Team Lead in preparation of materials for committees and cross-functional Working Groups as needed
Assists CTT Team Lead to establish strategy and policy, develop and implement processes, and ensure compliance with global disclosure requirements
Develops and maintains processes and systems to optimize efficiency, maximize content reuse and ensure quality
Evaluates trends and identifies areas for improvement. Supports CTT Team Lead in process analysis efforts and identifies opportunities to improve efficiency and effectiveness
Works cross-functionally and collaborative to evolve global transparency processes, procedures, performance measures, systems and communication
Develops global training strategy for transparency processes
Mapping of “as-is” processes and proposal of “to-be” processes
Develops policy based on Shire corporate position on Transparency
Develops best-practice processes to centralize, expand and optimize each area
Develops workflow and updating SOPs to support new processes
Establishes a communication plan to bring awareness and cooperation across contributing functions
10%:Support operational oversight and overall strategy for Aggregate Spend Reporting
Collaborates with required cross functional team to develop department- specific data collection processes
Supports data collection and formal reporting activities for Global Clinical Development Operations
Coordinates monthly submission into Shire’s reporting database
Bachelor's or Masters degree in scientific or related field is required; advanced degree is preferred
Knowledgeable of Global Clinical Trial Transparency and Data Sharing requirements preferred
Strong comprehension of GCP, ICH guidelines, and applicable regulatory requirements

Clinical Project Associate Resume Examples & Samples

1+ year of experience with Clinical Study planning, execution, reporting or publishing activities
Bachelor's Degree or equivalent education / degree qualification in Life Science / Healthcare
Previous experience at a local Medical organization, Investigational Site, Pharmaceutical company / CRO, or Clinical Fellowship Program

Integrated Clinical Solutions Resume Examples & Samples

Manage a team of project managers, consultants and analysts who are responsible for the project management, resource allocation and pipeline management of all projects related to Clinical Systems development
Engage with leadership in all functional areas, driving integrated IT planning throughout the business
Present professional communications to executive leadership in order to educate and influence opinions
Serve as a program expert across multiple projects, planning, managing, monitoring and implementing technology solutions in a variety of business contexts and maintaining a forward-looking perspective with regard to technological developments
Management/leadership experience with multiple accountabilities for budget and operations across diverse organizations, managing direct reports, including building human capital, managing daily workload, performance evaluations and timesheets, managing career development for employees
Business and technical product selection, and practical implementation of IT solutions
Collaborating and successfully fostering relationships with business executives, both internal and external, in order to achieve desired results, communicating with high level senior leadership, and problem resolution under tight deadlines
PowerPoint, Excel, Word, MS Project, and Visual Source Safe
Program and Project Management - Configuration Management, CMM/CMMI methodologies
Software testing and software releases, release management and release oversight
Oversight of testing, including compliance , testing, and verification of claims within multiple large scale environments and projects
UAT Processes and Procedures; and
Maintaining longevity with vendors and managing vendor expectations

Clinical Programs Group Lead Resume Examples & Samples

Accountable as the group lead by providing oversight to one or more Global Clinical Operations Lead(s) (GCOLs) and/or their associated programs,
Provides direction on strategic and operational issues in support of these programs
Serves as the point of contact for the Head of Clinical Programs for all clinical programs assigned
Provides functional input into the clinical development plans that aligns with R&D and Business Unit strategy
Provides strategic clinical programs input to the development/strategy team as required
Co-leads the Development Operations Team (DOT) with the Global Clinical Development Lead (GCDL)
Has in-depth knowledge of global regulatory/industry guidelines (e.g. ICH/GCP, promotional guidelines and labeling) to drive the clinical trial application process
Effectively represents the interests and perspectives of GCDO
Co-leads inspection readiness activities, and acts as subject matter expert during regulatory inspections
Bachelor’s degree or nursing qualification is required. Scientific/healthcare field preferred but not required. Advanced degree preferred
Previous line management or direct management (3+ years) of team members
Participation in marketing application review and submission
Experience managing financial budgets

Clinical Guidance Analyst Resume Examples & Samples

Experience in analyzing data and making recommendations to aid in decision making
Degree in Business, Engineering, Math, Health Administration, Accounting or related field
Excellent programming skills desired (SAS or SQL preferred)
SQL, SAS, Qlikview experience
Experience in HEDIS data analytics desired
Prior experience working with physician practice management systems desired
Certified medical billing coder desired

Clinical Systems & Technologies Analyst Resume Examples & Samples

10%: Maintain and administer Clinical systems as needed
20%: Vendor set up and CRO oversight
35%: Provide analysis in support of process improvement of Clinical Systems. Participate in projects to enhance clinical systems/processes. Define end user requirements and support. Provide administration support; manage permissions and security and recommendations for all issue/enhancement requests. Hands-on training support as required
30%: Collaborate with Process Optimization team and IT on system enhancements and roll out of changes/enhancements, including development of training materials/user manuals/learning solutions
5%: Responsible to interact with various levels in the organization including IT support for Senior Management
Bachelor’s degree (scientific, business or technical degree)
A total of 5 years of related work experience of which 3 should be in the pharmaceutical industry
Prior experience with Clinical Systems is highly preferred
Experience working as a liaison between IT and Clinical
Experience with IVR/IWR technologies
Understanding of Clinical data and how to present the data in a meaningful way
Experience with SDLC
Strong team, computer and analytical thinking skills
Individual must be self-motivated, effective follow-up skills and a demonstrated ability to respond to issues of a global nature is important
Strong organization skills and attention to detail are critical
Ability to work with changing priorities
Ability to communicate technical concepts with all levels of the organization

R&D IT Head for Clinical & Pharmacovigilance Resume Examples & Samples

Develop and deliver support in accordance with Service Level Agreements based on business requirements. Work closely with business partners in understanding and responding to both long-term and short-term R&D Clinical and Pharmacovigilance goals and strategy
Strengthen the delivery of transverse R&D Clinical and PV services, building or leveraging shared applications services
Deliver transverse analytics capabilities and leverage to support the mission of the R&D Clinical and PV organizations
Collaborate and negotiate with external partners to support system operations development / integration, ensuring reliability, competence, flexibility and cost effectiveness
More than 10 years relevant IT/Business experience managing and / or directing technology projects, including technology operations and the management and delivery of technology solutions. (required)
More than 10 years relevant IT experience managing/overseeing a Pharmaceutical R&D functional systems domain (i.e. Clinical, Regulatory, PV) and strong knowledge of IT Computer Systems Validation processes. (required)
More than 8 years of IT management experience and familiarity working in complex, global matrix organization (preferred)
M&A Experience (required)
Experience with Clinical and post marketing safety suites and specifically Oracle/Argus and including safety database, case processing, periodic submissions and also safety signal management (required)

Lead Clinical Standards Specialist Resume Examples & Samples

30%:Delivering Excellence: Takes leadership role in standards project implementation
Acts as Standards area project manager for selected standards projects. Establishes and maintains project plans and effectively articulates them; defines risks and recommends contingency plans as required
Mentors team members, junior staff or contractors via matrix relationships or direct supervision, in standards implementation, optimal usage and by directing work, resolving problems and/or providing guidance
Owns, governs and maintains designated GCDO developed standards models (including but not limited to: SDTM, CDASH, Terminology, ADaM, TFLs, document templates, questionnaires). Includes periodic assessment of standards content with respect to compliance and industry impacts
Leads assessment, implementation, integration and governance of systems and tools to support, manage, govern and report on standards
Conducts standards compliance review and works with functional areas and strategic service providers to reinforce content and interpretation of Shire standards.Collaborates closely with CROs/Strategic service providers to ensure appropriate management, training and deployment of Shire’s standards within the service provider’s infrastructure
Represents Shire and Global Clinical Development Operations as a member of SDOs or Standard Support Groups (e.g. CDISC, PhUSE)
Leads the assessment of updates and/or suggested enhancements to the standards library, standards knowledgebase/governance portal, OpenCDISC and other applications. Coordinates with IT where necessary
Contributes to the GDCO metadata standards management strategy and leads associated projects or initiatives
Contributes to budget forecasting and resourcing requirements. Reviews proposals and participate in the selection of service/technology providers. Manages contracts and statements of work
20%: Accountability and Ownership: Drives accountability at every possible level
Collaborates with Standards Team lead to identify and resolve issues impacting goal attainment. Leads resolution efforts
Contributes to the standards education and training strategy both internal and external. Develops and delivers training programs to affected internal and external staff
Ensures CRO/strategic service providers and Shire are deploying standards and leveraging them across the organization at an enterprise level
20%:Judgment and Decision Making: evaluates immediate business impact and takes decisive action
Stays current with changes in the external standards landscape and strategies, including requirements from regulatory authorities and agencies, and leads the development of recommendations for actions. Co-ordinates responses to provisional regulatory agencies standard requirements or requests for input or provisional SDOs documents
Continually assesses and makes recommendations on the standards deployment strategies and activities at the CRO/strategic service providers to ensure optimal benefit for Shire
15%: Serving Customers: Partnering with customers as a trusted consultant and becoming an integral part of customer’s decision making
Actively works with R&D functional areas to develop and manage standard documents and the reporting of related standards
Consults within and across Global Clinical Development Operations, and the CROs/strategic service providers to identify gaps, risks and inefficiencies and works with Standards Team Lead on solution development. Leads the implementation of the agreed solutions
Represents Global Clinical Development Operations in cross- functional standards and coding project teams
Interfaces with Global Clinical Development functions to ensure optimal process design leveraging standards infrastructure and scope
15%: Building Authentic Relationships: Building trusting relationships that will enhance current and future needs
Establishes and fosters strong collaborative relationships with strategic partners and service providers around performance, delivery, quality, innovation, and value
Coordinates with Standards Team Lead and peers to prioritize, and lead standards related initiatives
Manages the activities of standards management vendors. Ensures adherence to agreed specifications, timelines and budgets
Minimum 8-10 years in Data Standards or Data Management or Programming or Statistics. Strong working knowledge of CDASH, SDTM or ADaM, and CDISC controlled Terminology
Knowledge of XML preferred
Experience with leading teams and/or organizations

Clinical Innovations Analyst Resume Examples & Samples

Experience with SQL coding
Excellent organizational skills required
Advanced degree in Business, Health Administration, Computer Science, Accounting or related field
Resides within the New York Metropolitan area
Team Player with experience working with Clinical Associates

Clinical Guidance Technology Consultant Resume Examples & Samples

Offer second tier support for issues arising from the use of enterprise standard applications such as Microsoft Office and Project
Assist in the administration of routine tasks including zoning, masking and space monitoring, and new initiatives such as remote data replication and policy-based archiving
Create the documentation necessary to distribute applications to the desktop and server platforms
Provide ongoing technical advice, assistance, and training to fellow associates and to customers
Bachelor’s Degree in Information Technology or Computer Science, or equivalent experience
Working knowledge of the database technologies
Experience in MS-Access and SQL
Microsoft certification

Clinical Due Diligence Team Lead Resume Examples & Samples

Leads the GCDO team strategy and approach for in pre-due diligence and due diligence for both in-licensing and merger and acquisition opportunities
Build and sustain a highly respected GCDO due diligence team that works cross functionally and across therapeutic areas aligning strategy and operational execution, to support Shire in making informed decisions on business opportunities
Lead GCDO due diligence team in close partnership with GCDO internal teams to ensure seamless knowledge transfer and integration of acquired assets
40%: Pre-Due Diligence
Oversee GCDO participation and inputs for the pre Due Diligence Team, to evaluate target opportunities up to the decision point of progression to due diligence
Lead GCDO sub team in the generation of scenario generation consistent with the target product profile (TPP), generating clinical costs, enrollment assumptions, statistical assumptions, trial designs consistent with regulatory and commercial strategies, GCP and vendor assessments, operational feasibility and data analysis
Lead or co-lead the R&D sub team in the generation of visual development plans, project assumptions, key findings, probability of success estimates and full R&D costs
Oversee the request and review FTE inputs
Ensure the quality and consistency of all inputs provided to corporate finance in support of the valuation
Conduct pre-DD site visits as needed
Ensure concise written reports are provided as needed
Ensure endorsement and alignment with GCDO leadership for all assumptions and activities
40%: Due Diligence
Oversee GCDO participation and inputs for the Due Diligence Team, to evaluate target opportunities up to the decision point termination or progression to a business transaction
Lead GCDO sub team in the generation of scenario generation consistent with the target product profile (TPP), generating clinical costs, enrollment and statistical assumptions, trial designs consistent with regulatory and commercial strategies, GCP and vendor assessments, operational feasibility and data analysis
Lead or co-lead the clinical sub-team to refine trial designs, data analysis and other clinical issues
Support program management in the generation of visual development plans, project assumptions, key findings, probability of success estimates and full R&D costs
15%: Integration
Participate and provide inputs to the Clinical Integration Team, to ensure seamless knowledge transfer for all acquired assets
Ensure GCDO provide timely, high quality inputs for: human resource, IT, transition cost and portfolio decisions
Ensure continuity of all core expertise for key products, people and technologies
Communicate and support Integration team to facilitate synergies as quickly as feasible without compromising development or commercial performance
5%: Build and maintain GCDO Due Diligence Department
Assess short-term and long-range capabilities and resource needs
Develop and sustain quality feedback mechanisms to ensure the GCDO team is delivering consistent high quality outputs and working collaboratively on all teams
Make recommendations and allocations across projects
Serve as a role model for Shire Brave values within Clinical Operations
Line management of Clinical Due Diligence staff
Minimum Bachelors degree in a scientific discipline is required
Minimum 15 years experience of clinical research and organizational management within the pharmaceutical industry, a CRO or similar organization is required
Experience in problem solving, negotiations, presentation and collaborative team-building with non-direct reports required
Previous line management or direct management of team members required
Experience of global regulatory requirements required
Valuation, Commercial Assessment, Financial and business understanding required

Clinical Trial Project Associate Resume Examples & Samples

Solid mathematical, statistics and/or analytical skills
Degree in Mathematics / Statistics and or Computer Science / Information Technology
Experience in Clinical Research / Regulatory processes
Knowledge of Process Improvement Methodology

Clinical Engineering Manager Resume Examples & Samples

Hires, places and trains technicians and other staff within the CE department, and administers coaching, delivers performance feedback and issues discipline to direct reports
Establishes work priorities and provides daily supervision and support to all assigned staff
Ensures compliance with all Joint Commission/DNV and OHSA regulations and other local, state, and federal government regulations
Provides counsel to client regarding purchases of new capital equipment
Minimum of 5 years experience in related field, with at least 3 years of supervisory experience

Clinical Engineering Director Resume Examples & Samples

Requires a minimum of a bachelor’s degree in Biomedical Engineering, Electronically Engineering Clinical Engineering, Mechanical Engineering, or Information Technology w/concentration in Security or Physics
Master’s degree strongly preferred
5 years minimum experience required
Certifications or license desirable in one or more of the following: PM, CISM, EIT, PE and CCE
Requires proficiency with a PC and all Microsoft Office software, including PowerPoint, Excel, Access, Project, and Word, as well as mathematical analysis packages, etc

Clinical Resume Examples & Samples

Market level development, implementation and oversight of Clinical Innovation Outreach Specialist staff
Coordination of management efforts with other Humana departments including, but not limited to Health Services Onsite Staff, Case/Disease Management, Quality Improvement, and Provider Relations
Collaborate with Health Services Manager for data collection, reporting and Quality Improvement initiatives on all programs, including evaluating ongoing effectiveness and improvement opportunities
Provides daily oversight and guidance to non-clinical support staff
Maintain proactive communication with other departments to ensure efficient, accurate and timely responses to internal/external customer needs
High School Diploma or current LPN license in state of Florida with no restrictions
Sales and/or Customer Service experience
Proficiency in all Microsoft Office Programs, e.g. Word, PowerPoint, Excel, Access, etc
General understanding of economic, financial and operational concepts
Medical Terminology knowledge or Clinical experience

R&D IT Head for Clinical Resume Examples & Samples

Develop and deliver support in accordance with Service Level Agreements based on business requirements. Work closely with business partners in understanding and responding to both long-term and short-term R&D Clinical goals and strategy
Strengthen the delivery of transverse R&D Clinical services, building or leveraging shared applications services
Deliver transverse analytics capabilities and leverage to support the mission of the R&D Clinical organizations
Bachelor's Degree in the field of Information Technology, Engineering, Computer Science or a related study. (Master’s degree preferred)
More than 8 years working in the Pharmaceuticals or Life Sciences industry (preferred)
Experience with Clinical systems (e.g. Trial Mgmt, Data Mgmt, Medical Writing, Clinical Supplies, Biostat/Statistical Programming, Analytics and Reporting, eTMF, investigator portal, etc…) (required)
Experience with budgeting, planning, ROI/NPV model development, and IT governance

Clinical Intelligence & Analytics Associate Actuary Resume Examples & Samples

Associate of Society of Actuaries (ASA) designation
Meets eligibility requirements for Humana’s Actuarial Professional Development Program (APDP)
Advanced Technology Skills
Ability to certify statements of Actuarial opinion
Ability to translate technical issues to staff and manager
Project management capability - able to plan and organize work for self and others on a team
Experience in more than one discipline (e.g., modeling, pricing, rate filing, reporting & analysis, reserving or trending)

Biostatistics Team Lead-registries & Clinical Resume Examples & Samples

Serves as therapy area leader within biostatistics; interacts with project and product strategy teams and communicates therapeutic area plans and strategy to subordinates
Directs activities for selection of appropriate statistical methods for analysis of clinical study data; provides input into clinical development plans, approves clinical study reports and integrated summaries of safety and efficacy
Responsible for interacting with FDA personnel on clinical trial statistical issues in the design, analysis of clinical trials, design of other study types, and data presentations
Reviews regulatory documents such as CSRs, as well as summary documents
Consults with the Medical Writer and Physician on the interpretation of efficacy results
Contributes to the publication plan. Reviews abstracts, posters, and manuscripts to support Medical Affairs
Lead departmental process improvement initiatives and contribute to SOPs
Contributes to the establishment and maintenance of common formats and templates for key Biometrics documentation (e.g., statistical section of protocol, standard CRF pages, Statistical Analysis Plans, Tables, Figures and Listings). Contributes to the design of standards for SAPs
Directs outsourcing activities in collaboration with preferred vendors. Provides strategic and tactical input in the contracting with Global Biometrics preferred providers
Identifies the need for contractors and supervises contractors to support projects
Responsible for hiring, planning and assigning work, setting objectives and development plans, appraising performance, giving performance related feedback and rewarding and recognizing employees
M.S. in Biostatistics or closely related field is required
Ph.D. in Biostatistics or closely related field is strongly preferred
Generally has 10+ years of relevant pharmaceutical experience with 5+ years of supervisory experience
Strong background and working knowledge of statistical methods that apply to all phases of clinical trials and other study designs. Must have a working knowledge of statistical analysis plans including the report outline, mockup tables, graphs and data listing shells and appendices
Must have a working knowledge of all appropriate relevant regulatory guidance documents (e.g. ICH, FDA and EMEA)
Direct regulatory filing experience is required
Some people management experience strongly preferred
Proficiency in SAS is strongly preferred
Ability to help others understand the broader business and organizational context (inspiring and motivating others)
Demonstrated ability to deliver excellence by integrating planning efforts across departments or organizational boundaries to ensure organizational effectiveness (delivering excellence)
Demonstrates a customer focus by partnering with customers as a trusted consultant and serves as an integral part of customer’s decision-making process (serving customers)
Demonstrated ability to reinforce a culture in which partnering is a norm (global and cross-boundary communication)
Demonstrated ability to accept responsibility for individual and team performance (accountability & ownership)
Demonstrated ability to evaluate the business impact of decisions and remains committed to following through on agreed upon decisions yet remains flexible should priorities change (judgment and decision making)

Clinical Intelligence Actuarial Analyst Resume Examples & Samples

Apply expertise and technical support, under the guidance of seasoned associates, in matters related to the successful and financially sound operation of the company’s business to the department’s external and internal customers
Develop a library of metrics, methods, processes and reports in support of clinical strategy and development
Research and identify trend drivers
Collaborate with fellow team members as well as build productive cross-functional relationships within multiple areas of the organization
Working knowledge of Microsoft Excel, Visual Basic, and some database application (e.g., Access or SQL)
Leadership in extracurricular activity
Demonstrated learning agility

Clinical Intelligence Associate Actuary Resume Examples & Samples

Ownership of our Medicare Outpatient Early Indicator Report. This involves advanced SAS coding knowledge and an understanding of how to create completion factors and apply them to the claims data. This report drives our emerging trend findings to senior leadership
Maintenance of the completion model and reviewing monthly restatements
On point for any drilldown analysis related to this report that could involve claim line level research
Communicating results to our customers, which could include any number of people ranging from regional analysts to senior leadership
Handling ad hoc requests as necessary
MAAA
Advanced technology skills, including Excel and computer programming language such as SAS or SQL
Team building skills
SAS Coding Experience

Clinical Engineering Technician Resume Examples & Samples

Works with an experienced BMET in the installation, maintenance, and repair of biomedical equipment
Consults with higher level authority for resolution of difficult issues
Conducts departmental rounds with customers to promote communication and learn operations
Repairs, tests and calibrates equipment according to manufacturers’ recommendations and other established guidelines
Performs assigned duties in accordance with current policies and procedures, including equipment inspection, minor repairs and planned maintenance, all under the appropriate supervision
Assists in the ordering of parts and supplies necessary for the servicing of medical equipment
Completes assigned work in a timely manner
Prioritizes work load effectively
Shows initiative, follows established procedures, and works in a safe manner
Maintains timely, accurate and thorough documentation required by management, as outlined in current policies and procedures
Demonstrates initiative and concern for planning, time utilization and cost containment
Possesses knowledge of electrical safety theory, and performs electrical safety testing on biomedical instrumentation
Computer skills (MS Word, Excel, Outlook required)

Clinical Market Intern Resume Examples & Samples

Explore application of medicine to engineering, to understand key requirements in medical device development
Review medical and scientific literature to refine clinical needs
Participate in product concept generation activities, and conduct expert interviews
Review market research and competitive landscape to evaluate market size and define value proposition for innovative medical technology
Education: Medical related discipline, preferably in the final years of MBA program
Knowledge: understanding of medicine and management, with clinical experience
Skills: Able to interact with a multidisciplinary team of engineers and researchers. Excellent oral and written communication skills with the ability to communicate clearly to others in different functions, at various levels

Stars Clinical Task Force Consultant Resume Examples & Samples

Implement member and provider initiatives to improve Clinical Stars and Medicaid Quality scores
Work with Stars Divisional Consultants to determine the appropriate approach with the markets and identify recommendations/plays to drive rate improvement
Collaborate with vendors and other key stakeholders to develop relationships, resolve issues, and promote mutually beneficial strategies and processes
Activate coordination and engagement with key internal stakeholders that provide services and support to Humana and/or directly to members
Identify and evaluate data trends and determine the impact to Quality rates
Demonstrate ability to "tell the story" of each initiative demonstrating action plans and results
Ability to interpret and leverage data to improve strategy
Ability to use data to create, implement and track new initiatives
Excellent PC skills (including MS Word, and Excel)
Experience managing medium to large scale projects and or initiatives in a fast paced environment
Experience viewing data utilizing ClikView

100

Clinical Auditing Analyst Resume Examples & Samples

RN, LPN, or Certified Coder
Training/Facilitation experience (classroom and virtual)
Experience in guideline creation to include Visio flows
Excellent organizational skills desired
2+ Years broad clinic experience
3 or more years’ experience in the health industry, to include knowledge of
CPT code billing
Experience in quality auditing

101

Clinical Trial Operations Manager Resume Examples & Samples

10+ years of experience in pharmaceutical industry or clinical-related discipline
7+ years clinical research experience
4+ years of strong trial operations management experience

102

Clinical Programs Lead Resume Examples & Samples

Responsible for the strategic and operational oversight, management, and delivery of a clinical development program or study in support of Shire’s project strategy team
Authors, provides input, and/or oversees program and/or study level documents
Manages clinical outsourcing and may represent Clinical Programs on vendor oversight committees
Manages financial aspects of asssigned clinical program or study(ies) and provides to Development Team Lead
Responsible for strategic initiatives for process and business improvements
30%: Oversees or is responsible for
Significant clinical research experience (8+ years) with evidence of increasing responsibility within a pharmaceutical company or CRO

103

Clinical Evaluation Manager Resume Examples & Samples

3+ years of Utilization Review experience at a Managed Care Organization or Health Plan
Bachelor's or Master's Degree in Nursing
Exceptional documentation and clinical skills
Excellent communication skills (written and verbal
Certified Case Manager
Knowledge of Medicaid and/or Medicare regulations
Knowledge of Milliman criteria (MCG)

104

Clinical Evaluation Manager Resume Examples & Samples

3+ years of previous experience working within a Managed Care or Health Plan organization
Microsoft Office/Suite proficient (Excel, PowerPoint, and Word)
2+ years of experience in Utilization Review
Certified Case Manager certification
Strong cost containment / case management
Knowledge of Medicare/Medicaid and/or commercial regulations

105

Clinical Programs Lead Resume Examples & Samples

50%: Oversight with an emphasis on strategic planning, implementation and execution of relevant team and work stream plans for therapeutic indication(s) or company initiatives in keeping with corporate and department goals
20%: Responsible for the creation and management of budget & forecast for specified therapeutic areas or company initiative
20%: Align skills and resources needed for success; work closely with internal and external stakeholders to leverage and optimize resources
Align with team members from other functional areas regarding planning, implementation, tracking, analysis, and reporting of milestones
5%: Participate in business development and process improvement activities as needed
5%: Participation in Research and Development, a department and/ or corporate wide task forces as appropriate
Bachelor’s degree in life sciences, nursing, medical device –related area or equivalent college program required; Master’s preferred
Minimum 10 years clinical research or medical device/IVD program experience
Minimum 3-5 years project management experience in clinical research or medical device programs, including leading and/or managing staff directly
Advanced understanding of the design, development, and execution of clinical and development programs related to medical devices/IVD’s. Works on abstract problems
Demonstrated ability to handle multiple programs and/or therapeutic areas associated with a high degree of complexity; known as effective resource for organization on clinical methodology issues, drug development, process improvement initiatives and people management
Ability to synthesize complex medical and scientific information through demonstration of effective written, verbal and presentation skills to all levels of the organization
Demonstrated budgeting, forecasting, and fiscal management skills
Proven highly developed leadership skills with ability to supervise, mentor and objectively evaluate internal or external resources; resolve conflict, and collaborate effectively
Exert knowledge of FDA, ICH, and GCP guidelines

106

Outpatient Clinical Auditor Resume Examples & Samples

Certified Medical Coder with at least one of the following credentials: CCA, CPC, CCS, RHIA, RHIT
3+ years prior coding experience
Experience in prospective payment methodologies
Knowledge and experience in health care environment/managed care
Strong knowledge of Microsoft Office products (Word, Excel)
3M Coder/EncoderPro experience

107

APC Clinical Auditor Resume Examples & Samples

Ability to work independently and manage work load
Strong knowledge of Microsoft Access
Strong knowledge of ICD-9 coding

108

Clinical Guidance Specialist Resume Examples & Samples

Proficiency in Microsoft Office applications, including Word and Excel
Previous call center or customer service experience
Must be available to work any shift as required to meet business needs
Previous experience in the healthcare field

109

Market Clinical Strategies Process Analyst Resume Examples & Samples

Bachelor's Degree in business related field or equivalent work experience
High level proficiency with Microsoft Office applications (Word, Excel, Power Point)
Strong background data analysis and analyzing large sets of data
Experience in completing efficient analysis of data with associated conclusions and recommendations for improvement
Strong organizational and effective time management skills
Ability to work cross-functionally to achieve results
QlikView
Previous health insurance industry experience
Previous experience with Process Improvement methodologies

110

Clinical Assessment Developer Resume Examples & Samples

Bilingual – Must be able to speak, read, and write fluently in both English and Spanish
Masters in School Psychology or Bachelors in Speech-Language Pathology
Must have demonstrable expertise, training, and clinical experience in the area of psychological and/or speech-language assessment, as well as interest in applying aforementioned expertise, experience, and skills to the development of published print and digital clinical assessments
Must have strong oral and written communication skills in Spanish and English, good planning and organizational skills, interest and training and/or basic graduate level skills in research methods and statistics, ability to work as part of a team, flexibility, and desire to learn the test development and publishing process
Subject Matter Expertise: Expertise in assessment in the area of psychology or speech-language disorders, training and/or experience in research, and practical experience in both psychological/speech-language testing and intervention
One or more of the following skills are highly desirable

111

Clinical Innovations Analyst Resume Examples & Samples

2 years of Quality Assurance (QA) or Compliance experience
Strong analytical, organizational and time management skills
Comprehensive knowledge of Microsoft Word and Excel
Team Player, ability to work within stringent deadlines, multiple priorities, as well as work independently
Excellent interpersonal, written, and verbal communication skills
Bachelor’s or Associate’s Degree
Previous Medicare, commercial, and legislative/regulatory experience
Knowledge of Access
Knowledge of CMS guidelines
Quality audit background desired
Experience in project management
Bilingual (English and Spanish), preferred; must be able to read, write and speak English

112

Clinical Audit Data Consultant Resume Examples & Samples

Proficiency in advanced functions of Microsoft Excel and PowerPoint, Visual Basic and macros
Ability to gather data from multiple sources and compile it into a user-friendly format and present data, concepts, processes, and ideas to teams and leadership
Demonstrated skill in development of recommendations and implementation of solutions based on financial and other project data
Ability to develop new reporting based on an in-depth understanding of different types of reporting needs
Ability to absorb and retain information readily, prioritize tasks to meet fluctuating demands, and work under deadline constraints
Proven experience leading and supporting projects
Bachelor’s degree in Math, Economics, Statistics, Computer Science, or relevant industry experience
Intermediate knowledge of Microsoft Access, PLSQL, SAS, or TOAD
Ability to utilize analytical thinking in determining root cause from result data
Gifted in creative thinking and root cause analysis
Experience in the health insurance industry

113

Integrated Clinical Solutions Resume Examples & Samples

Bachelor’s Degree in Business or Healthcare field
Excellent PC skills required. Specific expertise with MS Word, Excel and Sharepoint required
Excellent communication skills - written and verbal
Previous budget and/or financial reporting experience
Previous data analytics experience

114

Clinical Disputes Analyst Resume Examples & Samples

Excellent communicate skills, both written and verbal
Ability to collaborate with multiple teams at various levels
Strong organizational/problem solving skills with ability to handle multiple priorities
Working knowledge of Excel and Access
Clinical experience/knowledge

115

R&D Clinical Trials Finance K-k-kb Resume Examples & Samples

Work with the senior management team to create long range financial and strategic plans
Drive strategic planning and work closely with other business groups to develop alternatives and strategies
Manage all inputs from cross-functional groups to the P&L models
Develop cost estimates for product development and research activities such as preclinical and clinical studies activities/accruals
Manage timeline and total project deliverables (develop presentations for senior finance management, final deck and model output summaries, etc)

116

Clinical Audit Analyst Resume Examples & Samples

Ability to handle multiple tasks with attention to detail
Strong collaboration, organizational, and problem-solving skills
Possess self-drive and strong initiative
At least 2 years’ experience with claim payments/processing
Microsoft Access
Associates or Bachelor’s Degree of Art or Science
Sharepoint Site Owner and/or Designer Training completed

117

Frontline Lead Non-clinical Team-intermountain Region Resume Examples & Samples

Report trends
Develop system-view recommendations
Implement appropriate actions to control trend
Create and conducts provider outreach initiatives
Ensure compliance with regulatory requirements
Recommend alternatives if appropriate using your knowledge of clinical protocols
Identify members for specific case management and / or disease management activities
Monitor multiple departmental activities, coordinating functions across utilization management and case management teams that drive positive outcomes for Humana members, Humana providers, and to Humana
Clinical experience in an acute care, skilled or rehabilitation clinical setting
May substitute equivalent education and/or experience for degree

118

Temporary Clinical Handscorer, Wisc Spanish Resume Examples & Samples

Apply judgment to score subjective data. Specifically, score brief verbal responses to questions that involve critical thinking, reasoning, recall of information, or providing definitions of words
Score subtests that require visual discrimination (e.g., evaluate marks that indicate examinee’s response to visually presented problems)
Score subtests that require objective data entry
Must be proficient in written and spoken Spanish and English
Critical thinking skills to apply basic scoring rules
Ability to perform independently without consulting others (i.e., willing to perform quiet work without discussing scoring decisions with co-workers)
Available to work at least 7.5 hours per day, Monday through Friday
Accept and respond to supervision from the Development Team, Team Leaders, and/or Scoring Supervisor
Flexible and willing to perform other clerical duties as needed (e.g., photocopying and filing)

119

Clinical Assessment Developer Resume Examples & Samples

Masters in School Psychology or Bachelors in Speech-Language Pathology (or related field)
Must have demonstrable expertise, training, and clinical experience in the area of psychological and/or speech-language assessment (or a related field), as well as interest in applying aforementioned expertise, experience, and skills to the development of published print and digital clinical assessments
Clinical/educational/research experience involving administration and interpretation, and/or development of clinical assessment instruments
Bilingual: ability to speak, read, and write fluently in both English and Spanish is preferred, but not required

120

Clinical Intelligence & Analytics Actuarial Analyst Resume Examples & Samples

Perform root-cause analyses to support leaders in answering the “why’s”
Meets requirements for Humana’s Actuarial Professional Development Program (APDP)
Prior experience with data analysis and reporting

121

Clinical Formulary Management Process Manager Resume Examples & Samples

Serves as the Clinical Formulary Process Manager overseeing the Medicare and Medicaid lines of business
Leads the development, maintenance and improvement of formulary processes. Ensures processes, policies and procedures are efficient and compliant with Medicare-CMS requirements
Manages the creation of new formularies and maintenance of existing formularies and drug lists in Humana’s formulary management system
Ensures accuracy and compliance of formularies and associated formulary data with Medicare-CMS regulations
Manages associates and grows staff talent
Prior formulary management and/or pharmacy claims processing systems experience
Expertise in Medicare-CMS regulations
Excellent data analysis and experience working with Access, SQL and Excel
Highly proficient with MS Word and Visio
Experience in a health services or technical field

122

Clinical Authorization Rep-pre-arrival Resume Examples & Samples

2 years of experience in a hospital, medical office/doctor’s office or working for a health insurer required
Oncology experience is preferred
Knowledge of the health insurance industry and claims processing a plus

123

Clinical Consulting Practice Resume Examples & Samples

Apply internal processes and enforce project standards
Review expectations/deliverables prepared by senior leadership/ business owner
Coordinate deliverables with business owner
Coordinate project plan and drive towards deliverables
Develop clear and concise documentation
Provide strong organization and effective communication skills (oral and written)
Facilitate regular status meetings with business owner/project teams/steering committees
Manage task/action item priorities
Report progress of project deliverables and milestones
Manage timely decisions to support project
Proficiency in communicating effectively with project stakeholders up to and including leadership
Obtain additional knowledge by asking questions, exploring different options, being creative and thorough, and open to new ideas
Regular use of Microsoft PowerPoint, Word, Excel, Project, Outlook, SharePoint and Visio
Have knowledge of and ensure completion of departmental intake forms when applicable
Adoption of Process Discipline philosophy and utilization of project management related support material
Project Standards: (Charter, RACI Model/Roles and Responsibilities, Governance Structure, Project Plan, Risk/Issues Tracking)
Bachelor’s Degree in business or related field or 10 years equivalent work experience
Ability to manage stakeholders and hold them accountable for deliverables
Ability to facilitate meetings with multiple participants capturing all relevant information
Ability to execute tasks captured in a project plan
Ability to manage deliverables from third party vendors
Project Management Institute certification - PMP
Prior experience in a clinical setting
Previous experience planning and managing large projects
Prior experience in the health solutions industry

124

Clinical Assessment Developer Resume Examples & Samples

Support various U.S. and international teams with the ingestion of test content onto digital platforms
Participate in user acceptance testing of digital and print materials to ensure all content and scoring requirements are met prior to market release
Train and support team members on use of digital tools for the creation, entry, and quality assurance of test content
Train and support Field Research Examiners on the use of digital tools for test administration
Document and provide detailed description of technical defects, and work with engineers and other development staff to resolve them
Develop item art specifications and work with the Design, UX, and Production teams to ensure that visual and verbal item stimuli meet both print and software specifications and usability standards
Participate in developing and refining test items and working with the Research Director, UX, Engineers and others on test content and format
Work with project teams to ensure that all test kit materials and deliverables, both in print and digital mediums, are prepared in a timely manner to meet the publication schedule
Manage scorers hired to score the verbal responses received on tests in development
Work with RDs and CADs from each team to determine future scoring needs, as well as the budget for those scoring needs
Work with Human Resources to hire individuals to score the verbal responses received on test research protocols
Work with department Administrator to obtain workstations and computers for scorers to do their work
Monitor the work of the scorers to ensure accuracy and reliability of scoring
Determine if scorers are meeting expectations, provide corrective feedback if they are not, and monitor progress towards goals
Work with other CADs to ensure scorers receive proper training and retraining as needed
Masters in Psychology, Experimental Psychology, School Psychology, or a Bachelors in Speech-Language Pathology. Related field acceptable
Must have strong oral and written communication skills, good planning and organizational skills, interest and training and/or basic skills in research methods and statistics, ability to work as part of a team, flexibility, and desire to learn the test development and publishing process
Good skills using basic computer software programs (e.g., Word, Excel) and the ability to use or learn digital communication tools such as video conferencing
Demonstrable expertise, training, and clinical experience in the area of psychological and/or speech-language assessment, as well as interest in applying aforementioned expertise, experience, and skills to the development of published print and digital clinical assessments
Digital Aptitude: Familiar with many coding languages and interested in learning new ones. Knowledge of HTML, XML, SAS, JSON
Proficiency with Adobe Creative Suite and the ability to create design specifications or test mock-ups
Familiarity with UX design principles and User-centered design
Experience creating an app or prototype (Axure, Bootstrap, HTML, CSS, JavaScript, etc.)

125

Clinical Innovations Data Analyst Resume Examples & Samples

Identify and document data quality issues and data capture gaps in order to identify analytical opportunities
Prior experience creating and delivering executive level presentations
Bachelor in Business, Math, Statistics, Public Health, Finance or other health related field preferred
Experience in managed care or health care administration preferred

126

Clinical Handscorer Resume Examples & Samples

Enter data from subtests into Scoring Assistant software
Organize, and electronically file protocols
English is the applicant’s first language. Proficient in written and spoken English

127

Clerical Specialist, Clinical Team Resume Examples & Samples

Professional experience in healthcare
Ability to multitask in a professional manner
Proficient in MS Office applications and a demonstrated technical aptitude to quickly learn new systems
Associate’s advanced degree

128

Clinical Messaging Consultant Resume Examples & Samples

Lead and drive the execution of Proactive Care Strategy initiatives, programs and projects associated with messaging and interventions
Develop interventions, programs and messaging for members in all lines of business
In partnership with various internal and external partners, the Clinical Messaging Consultant will evaluate operational feasibility, define operational strategies, develop implementation plans, oversee day to day performance monitoring and operations, and project evaluation completion
Manage strategic partnerships to drive successful roll-out of proactive strategy initiatives and define in flight modification and identify key insights for future strategy development
This position will provide oversight of flawless execution of initiatives and the management of performance, risks and issues for the following key areas: (1) Quality and Stars maximization, Clinical Trend and Pharmacy programs and services (2) Program engagement activities for targeting members for self-care programs for those newly diagnosed or those with low acuity chronic diseases, and (3) Complex multi-channel outreach programs to members and providers to close gaps in care, address non-compliance, and educate about chronic disease
Bachelors Degree in Nursing, communications, health education/promotion or any field
Process experience and/or Project Management experience
Experience working with vendors to deliver solutions that meet business objectives
Ability to manage/oversee multiple projects with cross-functional stakeholders
Excellent PC skills (including MS Word and Excel)
Experience working external vendors
Knowledge of healthcare and/or clinical concepts and conditions

129

Clinical Handscorer Celf-temporary Resume Examples & Samples

Score subtest that require objective data entry
Transport, organize, and file protocols
Photocopy, type, and perform miscellaneous clerical tasks
Available to work required schedule within Monday - Friday
Must anticipate reliable daily attendance with punctuality (e.g., arrive on time, leave and return from scheduled breaks/ lunch at appropriate times)
Accept and respond to supervision from Development Team, Team Leaders, and/or Scoring Supervisor
Be able to recognize questionable or problematic protocols that require attention from supervisors (e.g., cases with missing or unusual data, numerous cases with questionable data from the same examiner)
Experience Preferred: Prior experience scoring psychological tests

130

Clinical Optimization Technology Consultant Resume Examples & Samples

Derive observations and insights from metrics to support and improve clinical operations
Conduct independent research necessary to fully understand and correctly utilize the required clinical data
Continually identify ways to improve and enhance current reports, increasing value and usability
Highly proficient with reporting and query tools including MS Office (Access (develop/create queries) and Excel (building pivot tables, create tables, charts, graphs))
SQL, ability to build code to query database
Assist business leaders in understanding the “story” contained within or behind the data/report
Assist others on how to more efficiently code
Ability to build summary tables
SAS, ability to code queries
Strong mathematic and/or statistical skills

131

Clinical Innovations Specialist Resume Examples & Samples

Flexibility to work between 7 a.m & 7 p.m EST and occasional weekends, as needed
Previous healthcare/customer service experience in a clinical setting
Ability to communicate and collaborate with internal/external physicians, nurses and support staff through multiple mediums

132

Clinical Finance Consultant Resume Examples & Samples

Manage departmental activities to ensure accurate and timely financial and statistical reports and data are delivered
Develop methods and criteria for measuring and summarizing financial data and preparing complex analyses
Ensure departmental adherence to corporate guidelines, performance standards and all applicable laws and regulations
Strong financial reporting skills (expenses, profit)
Knowledge of Hyperion Smart View
Strong Excel proficiency (as defined by creating complex formulas within a cell, pivot tables, v-look ups, etc.)

133

Clinical Formulary Management Resume Examples & Samples

Bachelor of Science in Pharmacy or PharmD Degree
Active pharmacist license in the state(s) in which you are required to practice
3 years clinical experience in managed care
Previous experience with pharmacy benefits management
Previous Medicare and/or Medicaid experience
Strong organizational skills and ability to stay on schedule
Proven problem-solving and troubleshooting skills
Ability to work independently and within a team setting to achieve goals and meet deadlines
Excellent verbal and written presentation skills with ability to communicate effectively across all levels of the organization
Ability to take initiative, multi-task, and work in a fast-paced environment
Comprehensive knowledge of Microsoft Office applications, including Word, PowerPoint & Excel
Ability to manage end-to-end-processes
Understand Humana’s business processes, systems, tools, regulations and structure and how they interrelate to provide products and services that create value for Humana members
Previous management experience and ability to lead teams
Previous program or project management experience
Proven success in leading teams (both direct and indirect) with multiple accountabilities
Lean, 6 sigma experience and/or certification

134

Clinical Finance Analyst Resume Examples & Samples

Maintain the general ledger to include preparation of journal entries, account analysis and reconciliation, supports the month end close process
Prepare and present financial data to management for review and decision making
Research and analyze financial information necessary to support internal and external audit activity
Bachelor’s Degree in Finance, Accounting, Business or related field
Highly proficient with MS Office (Access and Excel)
Team player with strong interpersonal relationship, team building, collaboration and facilitation skills
Must have ability to work closely within a small team or independently
Experience assimilating data and information to make prompt decisions and share results with colleagues
Must possess strong data analysis skills
Strong problem solving and troubleshooting skills, especially around data acquisition and delivery
Ability to effectively communicate with co-workers, other departments, and leadership through written and verbal communication in the highest professional manner
2-3 years or more of professional work experience
ESSBASE experience

135

Clinical Assessment Test Data Entry Resume Examples & Samples

Assist various departments in typing correspondence and legal documents
Perform database work and data entry
Responsible for other administrative tasks such as filing, scanning, copying/binding
Edit and proof documents as necessary

136

Clinical Handscorer Wisc-v Spanish Resume Examples & Samples

Apply judgment to score subjective data. Specifically, score brief verbal responses to
Receive and respond to training in the aforementioned responsibilities
Spanish is the applicant’s first language. Proficient in written and spoken Spanish
Sufficient computer skills to perform data entry (e.g., basic word processing, web browsing, Excel)
Achievement of a scoring accuracy rate of at least 90% after training and maintenance of that level throughout the scoring assignment
Ability to perform independently without consulting others (i.e., willing to perform

137

Clinical Sciences Leader Shanghai Resume Examples & Samples

Rigorous
Multi-tasking - Capacity to manage several activities in parallel with respect to established schedules
Good communication skills (verbal, written and presentation skills)
Managerial skills

138

Clinical Formulary Management Resume Examples & Samples

Provides clinical operational leadership for build, maintenance, submissions and updates of formularies and drug lists
Ensures accuracy of formularies and utilization management (UM) criteria in the Centralized Formulary System
Evaluates new medications and accurately incorporates them into Humana’s formularies if appropriate
Researches and resolves member benefit inquires
Understanding of UM criteria for step therapy, prior authorization, and dispensing limits
Partners with other functions to operationalize formularies and related products
Actively participants in Pharmacy and Therapeutics Committee and Drug Utilization Review team meetings
Collaborates with other pharmacists and healthcare professionals in a team environment
Manages and communicates line of business priorities
Performs formulary analysis and reporting
Provides excellent service to our customers and key stakeholders
Develops and leads metrics discussions to deliver process improvements and business results

139

Senior Director of Clinical Engineering Resume Examples & Samples

Hires, places and develops management and supervisory staff within the CE department, while maintaining a strong focus on retention and team development
Maintains an active succession plan for key roles within the system
Oversees implementation of human resources polices and procedures, including regular performance reviews and effective performance management, in a corporately responsible manner
May manage multiple-site systems and multiple client relationships
Establishes productive business relationships within the C-suite
Schedules and documents communication with client on a monthly basis, to include Quarterly Joint Reviews and Annual Performance Reviews, that focuses on marketing the accomplishments of Aramark
Makes sound decisions, independently, to drive service delivery outcomes to the satisfaction of key client stakeholders throughout the hospital
Maintains departmental policy and procedure manuals ensuring 100% compliance with Aramark Healthcare Technologies standards
Seeks out new business opportunities for Aramark within account
Master’s degree in biomedical equipment technology, electronics, or engineering preferred
Minimum of 10 years experience in related field, with at least 8 years of supervisory experience

140

Cerner Clinical Strategist Resume Examples & Samples

Bachelor's degree in Nursing or in a related field
5 years of experience as a Registered Nurse
Current active Registered Nurse license
Have not been censured or forced to relinquish license due to impropriety
Ability to travel up to 100%
Inpatient (acute and critical care) nursing experience
Four years of healthcare management experience

141

Clinical Interaction Specialist Resume Examples & Samples

Conducts calls with patients, reviews the case file and completes a medical interview to obtain the required information as designated by the TeleMed interview system
Uses a consultative approach supported by medical knowledge and defined policies and procedures to uncover and collect information regarding conditions, treatment, medication usage, recovery etc
The CIS has a focus on providing an excellent customer service experience to all patients, acting as an advocate for them by providing information about preventative care available through their insurance carrier
Acts as a courteous, professional medical representative and customer advocate to obtain necessary information, document collected information efficiently and credibly to ensure a complete and accurate medical interview is completed and filed with the insurance carrier. Demonstrates empathy and compassion when needed
Responsible for following defined policies, procedures and standards for professional conduct, the CIS must perform within Quality standards to ensure consistent, accurate, professional patient interactions
Acts in compliance with all HIPAA guidelines and standards of care in patient interactions. Uses good judgment, tact and compassion to handle the delicacy of exchanging personal health information and the nature of sensitive medical information
Maintains a consistent knowledge of all Client programs which he/she has been trained on. Willingly accepts additional training to expand skills to become capable of servicing a higher number of patients across varying client programs
Accepts responsibility for actions and executes transactions with the knowledge that every interview is confidential and information obtained requires extreme accuracy as the information collected generates legal documents which are filed with the insurance carrier
HS Diploma/GED is required
Must have completed a degree in an approved accredited program as a Medical Doctor (MD), Registered Nurse or Licensed Practical Nurse
Must have strong customer service skills
Medical Terminology is required
Typing 25 wpm
Proficient with computer/internet research skills
Strong oral communication skills
MUST BE ABLE TO WORK MONDAY - FRIDAY 12:30 - 9 P.M

142

Clinical Excellence Practice Leader Resume Examples & Samples

Bachelor's degree or equivalent experience required plus 10 years of relevant experience in the clinical consulting field plus software application experience in the healthcare industry
Experience in health care quality management, administrative case management, public health administration or other research based outcomes evaluation necessary.&#8217
Ability to regularly interact with senior management or executives on matters concerning several functional areas, divisions and/or customers
Requires the ability to change the thinking of, or gain acceptance from others in sensitive situations, without, while maintaining productive relationships
10 years experience in growing and developing professional teams to deliver new offerings
Knowledge of healthcare software
Knowledge of software development process
Knowledge of product integrity matrixes
Time management and Organizational skills
Ability to communicate effectively, both verbally and written, with customers, co-workers and business contacts in a courteous and professional manner
Strong analytical ability
Ability to establish effective, professional working relationships with clients and co-workers
Experience in Six Sigma

143

Clinical Site Director Resume Examples & Samples

Active New York State Registered Nurse license
Background in any surgical specialty
MSN

144

Clinical Guidance Specialist / Vsp-san Juan Resume Examples & Samples

Associate’s or Bachelor’s Degree in clinical related field
Familiarity with medical terminology and/or ICD-10 codes, CPT’s , HCPCs
Bilingual English/Spanish

145

Clinical Evaluation Manager Resume Examples & Samples

3+ years of experience in a managed care organization or acute inpatient hospital experience in chronic or complex care
Strong computer and typing skills
2+ years' experience in utilization review with strong cost containment/case management

146

Manager, Market Clinical Strategies Analytics Resume Examples & Samples

Lead a team of associates to develop and produce reporting packages the support HSO operations and Medicare clinical programs
Maintain and enhance current Medicare clinical operations dashboards for tracking and reporting of key business indicators
Support rollout of new system functionality, including responsibility for operational readiness validation, post production validation and triage of issues encountered
Further the Market Clinical Strategies vision for continuous improvement by assisting in identifying best practices in Humana’s Medicare Regions and formulating proposed solutions to address identified barriers
Develop team members to meet the goals of the organization (Enhancement tracking, Training and Communication, Issue tracking and resolution)
Bachelor’s degree in Business, Information Technology or related field
Minimum two years of recent experience with SQL reporting (SQL Server Enterprise Manager, SQL Server Management Studio, etc)
Proven experience utilizing technology to facilitate data automation/report creation
Proven experience with very large data sets
High-Level proficiency with Microsoft Office suite (Advanced Excel and Access proficiency)
Excellent organizational and multi-tasking skills required
Previous experience with Medicare line of business

147

Clinical Auditor Resume Examples & Samples

1 year outpatient auditing experience
Strong knowledge of CPT/HCPS coding
Proven proficiency for APC and observation coding

148

Clinical Applications Leader Resume Examples & Samples

Contribute to the definition, design and refinement of software products and services to address customer needs
Establish and maintain close contacts and collaboration with external Key Opinion Leaders and researchers (directly and through sales organization) to build a network of high profile customers by developing advanced applications with them and create or sustain Reference sites, establish credibility and drive clinical strategy
Participate in Medical Advisory Board meetings to build application roadmap and provide input to Product Marketing
Assist with the reporting of data at scientific congresses, customer seminars and internal training events
Support the development, maintenance, improvement & implementation of working routines/standards for experimental procedures, reporting of consultancy projects, contracts with customers
Identify opportunities to use the results of process development projects in sales situations or marketing material. Facilitate and support the transfer of this information into the corresponding marketing and product management teams
Responsible for the clinical evaluation of new software, options, and systems prior to release
Establishes link between Global Clinical Insights and local Sales and Applications team
Bachelor’s degree in a relevant scientific or clinical area, or current Sonography credential(s) and/or Medical degree
Highly qualified in multiple clinical ultrasound applications
Experience working with Customers
Experience in communicating scientific data (lectures, posters, papers)
Ability and willingness to travel, including international travel

149

Clinical Marketing & Applications Specialist Resume Examples & Samples

Provides
Monitor customer
Interface
Communicate
Required active professional clinical/technical certifications/registries necessary to perform ultrasound scanning on live patients in a clinical environment (General Imaging)
Willingness to travel extensively within your specified geographic region as well as to occasional nationwide or international sites. Representation in meetings and tradeshows may additionally be required
Experience in communicating scientific data (talks, posters, papers)
Innovation – develop new ideas through collaboration and execute on creative ideas
Teaching ability: present complex material/ techniques in comprehensible terms
Fluency in English (spoken and written)

150

Clinical Trial Materials Manager Resume Examples & Samples

Responsible for developing strategies for investigational product packaging design in support of early and late stage development clinical studies conducted by client
Serve as liaison with Clinical Operations for investigational medicinal product (IMP) supply needs and timelines, including clinical supply forecasting, supply strategy development and implementation
Coordinate and oversee IMP packaging and labeling activities at contract manufacturers, including review and approval of packaging and labeling documentation and batch records
Utilize project management and interpersonal skills to deliver packaging products to deadlines and within budget
Generate and review packaging, labeling and storage sections of relevant clinical and regulatory documents; ensure cGMP compliance in packaging, labeling and distribution activities
Manage shipment and storage of bulk drug product and finished drug product for development phase programs; track the import and customs clearance of supplies being shipped to study sites and depots
Coordinate return and destruction of clinical supplies from study sites

151

Clinical Intelligence & Analytics Metrician Resume Examples & Samples

Bachelor’s Degree in Math, Engineering or a related field
Experience using Structured Query Language, SAS and/or SPSS
Graduate Degree in Applied Sciences or Statistics
Actuarial background, preferably near Actuarial Sciences Associate level
Experience with large data sets and/or the analysis of patient-level healthcare
Knowledge of Oracle

152

Clinical Application Engineer Resume Examples & Samples

Design input for the requirements of customers in respect of C-Arm product work flow, user interface, operational usability, good practice …… to translate all of these requirements into interaction design concepts
Responsible for the external evaluation or clinical trial of the newly developed products. It includes the clinical site choice, agreement with the hospital as evaluation site, clinical support during all process of the evaluation, collection of the clinical data and drafting the clinical evaluation report eventually
Enhance the clinical experience within engineering team. Contact hospital to organize engineers to participate in clinical observations in real surgery operation, manage the expertise to give clinical class training for all develop engineers
Clinical validation for the newly developed products. Verify all workflows of the newly developed product, posing as an end-user. It includes drafting the validation procedure/plan, conducting the validation, evaluating the acceptance of the product from an end user viewpoint, and give the finally validation report as program required
Risk assessment to the product quality complaint in respect of clinical applications, to find the potential hazardous situation from the user-using standpoint and give the mitigation proposal
IB support, to give customer high quality clinical operation training to enable them to use the new product better. And help them to have some trouble shooting ability related with product operation
Create or innovate new application concept, which could be highly accepted by customers and bring much benefit once integrated into product

153

Clinical Trial Management Resume Examples & Samples

A minimum of a Bachelor’s degree or equivalent University degree is required
Minimum of 8 years clinical trial management experience in the pharmaceutical industry or CRO is required, however, other relevant experiences and skills may be considered
Clinical research operational knowledge is required
Prior global clinical experience is required
Knowledge and familiarity of ICH Guidelines; familiar with FDA regulations and the EU Clinical Trial Directive and other applicable GxP regulations
Thorough understanding of current Clinical R&D processes, practices and systems
Experience or ability to work cross-functionally and in a matrix environment, with ability to liaise with key customers is required
Excellent Presentation and facilitation skills is required
Able to transfer knowledge to others in team or department applying knowledge of how to deliver training sessions for maximum impact and retention is required
Able to independently plan, organize, co-ordinate, manage and execute assigned tasks is required
Strong networking and relationship building skills
Ability to create an open and inviting environment
Ability to Embrace generational differences
Exceptional written and verbal communications skills
Proven coaching skills
Proficiency in English language (both oral and written) is required.Clinical Trial Coordination

154

Clinical Franchise Leader Vaccines Resume Examples & Samples

ICH-GCP
Company SOP/WI relevant to the job
Minimum 5-10 years industry experience in drug/vaccine development

155

Clinical Product Analyst Resume Examples & Samples

Acts as the Product Owner within an Agile scrum team performing the following
Troubleshoots in support of issues that come up from Services Team
Provides training on the product to other groups and may support training efforts with Customers
Works closely with Product Management to understand the strategic roadmap and provides input
Keeps current with industry trends and domain expertise
Establish a commitment to quality and communicate the importance of meeting statutory, regulatory and customer requirements. Ensure quality policy is understood, implemented and maintained at all levels of the organization. Establish and communicate quality objectives that are measurable and consistent with the quality policy
Maintain adequate organizational structures and adequate resources of sufficiently trained personnel. Ensure qualified personnel relative to assigned responsibilities. Ensure appropriate responsibility, independence and authority of all personnel who manage, perform and assess work affecting quality
Bachelor’s Degree in Product Management, Marketing, Engineering, Business Administration, healthcare or related field
5+ years’ experience in product management, product development, or related field
Clinical background is a MUST
MBA or MBBS, BDS or equivalent degree related
5+ years’ experience in product management, product development or related field
Healthcare product/industry/technical acumen
Demonstrates ability to problem solve
Proven ability to influence and negotiate internally and with customers

156

Clinical Trial Financial Analyst Resume Examples & Samples

Invoice industry sponsors in a timely manner to ensure payment
Reconcile and monitor of clinical trial expenditures and payments
Review research expenditures to ensure accuracy and appropriateness prior to billing sponsor
Prepare monthly reports using SAP accounting software, BRAIN, QuickBooks, Clinical Trial Management System (CTMS) and/or contract tracking data
Maintain budget section in clinical trial management system
Track all revenue and expenditures related to studies in QuickBooks/CTMS
Maintain Investigator efforts and communicate effort with Investigator
Interact with outside affiliates to obtain pricing related to research costs
Analyze and manage clinical trial budgeting, billing and revenue processes
Manage the process of opening, closing and maintaining clinical trial accounts in related financial systems
Assist with creation and reconciliation of internal/external billing policy ensuring compliance with applicable federal regulations
Develop and maintain SOPs and procedural guides
Maintain data of all active, pending, and closed RRO clinical trials
Prepare detailed cost assessments for industry sponsored clinical trials and investigator-initiated studies
Serve as an information resource related to contracts for faculty, fellows, and staff. Maintain calendar for quarterly meetings with investigators
Ability to understand and manage the complexities of research contracts including issues related to informed consent, access to data, and conflict of interest
Excellent interpersonal skills, including the ability to work with faculty members, co-workers, support staff throughout the institution, and pharmaceutical company representatives
Direct experience in the financial planning of clinical trials strongly preferred
Strong attention to detail and data quality
Independent self-starter and leader, with a strong sense of ownership of driving for results

157

Clinical Trials Specialist Resume Examples & Samples

Coordinate and perform a variety of duties involved in the collection of data in support of clinical trials research studies, through clinical assessments, interviews and observation to include interpretation and documentation of data
Follow established guidelines in the collection of clinical data and/or administration of clinical trials; assist in the determination guidelines for new protocols
Confer with site coordinators and physicians to explain protocol and to elicit compliance with regulations; ensure adherence to FDA and protocol guidelines
Identify potential problems and/or inconsistencies and inform supervisors as needed
Prepare a variety of reports, documents and correspondence for regulatory agencies, participating clinical trials sites and internal purposes to assist in the ongoing monitoring and evaluation of the clinical trial's progress
Assist principal investigators and/or other members of the research team in the development of plans and protocols for clinical research studies
Recommend modifications to existing procedures and techniques to meet the needs of the particular clinical trials research study
Ensure distribution and maintain inventory of appropriate forms, supplies, equipment, laboratory samples and drugs required for execution of research protocol(s)
Review work of lower level personnel within designated areas and assist in training new personnel

158

Adjunct Clinical Supervisors Resume Examples & Samples

Ph.D. or Psy.D. in clinical psychology from an APA-accredited program
Completion of an APA-accredited predoctoral internship
Licensed as a psychologist in the commonwealth of Virginia
Prior experience in clinical supervision; and
Prior experience with evidence-based interventions

159

Clinical & Advanced Course Manager Resume Examples & Samples

Overseeing the administrative operations of courses, including creation and management of complex schedules; reservation and preparation of classroom and clinical space for course sessions; and creation of faculty and student assignments
Implementing innovative educational technology solutions with an ability to acquire proficiency in emerging applications
Addressing educational technology requests from faculty and directing them to the appropriate resources in OCS and/or IT
Collaborating with clinical site administrators and coordinators
Planning and implementing clinical exercises, including those with patients
Tracking and providing faculty teaching effort data to inform the teaching compensation process
Delivering online curriculum materials in a newly adopted learning management system,
Organizing and actively participating in course and clerkship meetings, including setting agendas, presenting logistical and policy updates and action item follow up
Implementing the course and faculty evaluation process, and managing student assignment distribution/submission
Providing statistical and informational course data as required
Actively participating in, and providing ongoing senior staff support to, curriculum redesign and continuous improvement initiatives
Delegates tasks to and provides performance feedback for Clinical Courses Staff Assistant

160

Clinical Instructional Fellow Resume Examples & Samples

A short statement (no more than 1000 words) describing relevant experience
Writing sample (10 – 15 pages preferred)
List of at least three references; and
Law school transcript

161

Clinical Reseach Specialist Resume Examples & Samples

Participate in the evaluation of the protocol, study design and risk to subject population. Access and extract information for protocol development from medical library and online databases. Participate in protocol development or review of risk assessment for investigator-initiated trials. Assist in determination of staff availability and assessment of study population/availability. Participate in the preparation and negotiation of study budget. Determine facility/equipment availability. Participate in critical evaluation and make comment on contracts/agreement. Compose and supervise preparation of regulatory documents including updates to Informed Consent forms
Schedule study-related meetings and training sessions. Schedule and/or coordinate pre-study visit of sponsor/s
Identify potential subjects from review of existing protected health information based on Inclusion/Exclusion criteria. Recruit subjects according to IRB/protocol approved methodologies. Consent subjects including discussion of treatment and intervention alternatives and ensure that Informed Consent forms are properly signed before the start of the study. Determine appointments per protocol. Schedule and/or call subjects for appointments. Coordinate subject visits with support services
Will conduct study related assessments; provide or create source documentation tools; maintain files of drugs and oversee the proper handling of lab specimens

162

Clinical Laboratory Specialist Resume Examples & Samples

Position maintains both research and clinical diagnostic test environment
Performs a variety of technical procedures, including but not limited to: bloods, bone marrow, fresh, frozen, plastic, or paraffin specimens in the assigned laboratory
Maintains divisional compliance with all regulatory standards and adheres to all established QA/QC procedures. Documents results under quality assurance guidelines and provides recommendations to technical staff
Following standard operating procedures for preparing samples developed for molecular assays in support of patient care and research
Troubleshoots implementation of new venues or protocols to the lab SOP's. Develops new quality standards for molecular assays
Works closely with Laboratory Manager and Medical Directors to understand their scientific questions/aims, and offer support, implementation, and analysis of any type of molecular assay to reach their goals
Performs literature search and review, orders necessary supplies; in preparation for development
Ensures that data is accurately maintained and organized. Records timelines, status reports, and logs. Maintains laboratory notebooks
Works with laboratory support staff and assists in the training of technical personnel
Strict compliance with patient care and confidentiality policies. HTPAA regulations

163

Director of Clinical Finance Resume Examples & Samples

Clinical finance or academic medical center experience
Demonstrated knowledge of Stanford financial and decision support systems
User knowledge of Microsoft Office Suite
Advanced knowledge of Oracle or other business financial systems
Advanced understanding of financial principles
Ability to clearly and effectively present information to internal and external audiences, client groups and all levels of management
Strong analytical skills to review and analyze complex financial information
Strong leadership and management skills with previous experience managing people, delegating workload and providing direction/corrections as necessary
Knowledge of property management requirements related to Stanford or non-Stanford title of equipment and fabrications
Demonstrated competency in project management of a high volume of work, some of which is cyclical
If managing sponsored projects, ability to manage post and pre award administration for sponsored projects within his/her unit. Knowledge and fluency of governmental regulations and Cardinal Curriculum level I and II
Knowledge of procurement needs, including sole-sourcing, cost analyses, vendor requirements, and small business reporting
Experience working successfully with PIs, their administrative staff, the office of sponsored research and external sponsors
Demonstrated success in performing meticulous, high quality and compliant work
Ability to interpret complex research and fiscal policies, assimilate information from a wide range of resources and act like a mentor and resource to others

164

Clinical Trials Disclosure Manager Resume Examples & Samples

Biostatistics or scientific background preferred
Stanford University or Academic Medical Center knowledge preferred
Strong knowledge of NIH regulations, and ClinicalTrials.gov
Bachelor’s degree and five years of related experience including two years of supervisory experience or a combination of relevant education and experience
Experience in a lead role and interactions with federal agencies, i.e. FDA
Expert knowledge of regulatory affairs, including IRB review and approval process and Good Clinical Practice
Knowledge of International Conference on Harmonization (ICH) standards
Experience in developing and implementing multifaceted projects

165

Assoc Clinical Dept Admin Resume Examples & Samples

In conjunction with Chair and Administrator, analyzes opportunities to develop programs within the department
Develops and maintains weekly, monthly and annual reports to monitor activities and expenditures in the department
Directly supervises one Unit Manager and indirectly supervises the Unit Manager's subordinate staff; directly supervises surgery scheduling team and billing and coding team
Prepares/compiles/writes complex reports that summarize department's goals and accomplishments. Develops policies and procedures for administrative functions in the department
Assists the Medical Director in development and marketing plan for new services and referral sources
Acts as representative of the clinic at community events, professional meetings and conferences. Supervises clinic personnel who may be participating at these events
Serves as purchasing liaison for BA and PO related purposes; applicable towards agreements, and vendor set-ups
Assists with Inventory tracking within the clinic
Experience with reviewing and submitting contracts

166

Clinical Document Specialist Resume Examples & Samples

Responsible for QC and review of study documentation for Trial Master File (TMF) quality for sponsor and/or CRO studies
Responsible for resolving queries of the QC1 and QC2 reviewers before they are escalated to the PM and senior document specialists
Be proactive in researching eTMF or available resources to find answers to the queries of QC1 and QC2 reviewers
Assist senior document specialists for conduction trainings for new joinees, re-training for team members as required on an ongoing basis
Assist study leads to ensure smooth functioning of assigned projects from start to end
Assist study leads for managing Q&As for assigned projects
Coordinate with PMs for requirements of updates in system configurations or mapping documents
Assist the PMs for client meetings or provide them required data on assigned projects as required by the clients
Assist senior document specialists for performing internal audits
Review audit plans before finalizing with the client and ensure the internal audits are performed as per Audit plan
Perform random QC checks on assigned projects to ensure eTMF quality
Come up with valuable suggestions for improving the processes and performances of fellow team members
Be able to take up mentorship role for fellow team members as required
Coordinate with all the team members across the globe and ensure that all the teams function in a similar way across a project to ensure consistency
Assist with User Acceptance Testing during product development and release
Work on cross functional teams including Project Management, Business Development Client Services, Development and IT on the implementation and management of client projects
Gather and provide feedback on features and enhancements that may be needed on an ongoing basis to development team
Serve as part as the Project team on client projects
Participate and become an expert in the TMF Reference Model and stay current on regulatory changes
Become an expert in Trial Interactive features and functionality and work with GM, Life Sciences Solutions, Project Management and Development to recommend new features and functionality to improve the product and reduce manual activities
Respond to client requests for new project initiatives. Collaborate with various members of the production and sales teams to assess the scope of work and produce cost estimates
Take a proactive role in learning about clients’ industry, business needs and company culture, educating the project team, identifying new business opportunities and providing a high level of service
Set and fulfill client expectations
Perform other special projects or duties when required
Minimum Bachelor’s Degree from a 4-year college or equivalent
Minimum of 4-6 years of experience in the life sciences industry
Previous employment in Pharmaceutical, CRO, Medical Device, Investigative Site or eTMF preferred
Experience with essential documents and other study documentation
Knowledge of clinical development phases and processes including GCP and ICH regulations
Experience in a leadership role preferred
Proficiency in Microsoft Office (Word, Excel, Outlook), and knowledge of eClinical technologies
Proficiency in Document Management, (Adobe professional, knowledge of Scanning, indexing, using of ISI Tools and Capture Perfect)
Must be able multitask in a fast-paced environment, work well with people from a variety of different backgrounds and cultures, build relationships with clients and co-workers, work independently and as part of a team, take active measures to solve problems and commit to a high level of service

167

Clinical Document Scanner Resume Examples & Samples

Proof of high school diploma or GED required
File and/or scan/uploading experience
1 - year clinical or medical records experience
Prior office or clerical experience
Able to multitask in a fast-paced environment
Prior experience in the Life Sciences industry (pharmaceutical, biotechnology or CRO experience preferred)

168

Clinical Document Specialist Resume Examples & Samples

Responsible for Trial Master File (TMF) quality for sponsor and/or CRO studies
Assist in Periodic audits of client TMFs as well as internal TMF audits
Prepare, process and track paper & electronic documents received as per project guidelines in a timely manner
Ensure documents are scanned, imported, coded, and indexed into the (e)Trial Master File and reviewed for quality on an ongoing basis
Archive all paper files and maintain an ongoing inventory list of all received files as per guidelines
Liaison with internal and regional teams to ensure completeness and quality of documents
Plan and perform periodical quality checks of (e)Trial Master Files & the Paper TMF Files to identify any filing issues experienced by the Clinical Trial Teams to ensure that both (e)Trial Master Files and Paper TMF Files meet internal and external quality standards
Assist in writing and editing SOPs to keep current with industry changes on TMF management, quality and archival
Assist in Training team members as well as other TransPerfect Life Sciences Production teams on essential documents and regulatory requirements
Participate in and become an expert on the TMF Reference Model and stay current on regulatory changes
Take a proactive role in learning about clients' industries, business needs and company culture, educating the project team, identifying new business opportunities and providing a high level of service
Ultimately responsible for submission and inspection readiness of the TMF
Minimum Associate Degree in Science, Preferred BS from 4-year college or equivalent
Minimum 3 years experience in the life sciences industry
Previous employment in Pharmaceutical, CRO or Medical Device industry
Previous experience overseeing TMF audits, internal and/or regulatory audits
Experience collecting, scanning and coding TMF documentation
Experience in overseeing and training employees on TMF SOPs and regulatory requirements
Proficiency in Adobe Acrobat Professional, ISI Tools and web-base document indexing and viewing application. Knowledge of scanning, extracting, uploading, OCR, rendering, bookmarking/linking, document verification and compiling
Proficiency in Microsoft Office (Word, Excel, Outlook), eTMF and eClinical technologies
Works well with people from a variety of different backgrounds and cultures
Builds relationships with clients and co-workers
Takes active measures to solve problems and commit to a high level of service

169

Ctrc Clinical Trials Operations Manager Resume Examples & Samples

Develops operational policies and procedures to standardize the responsibilities and communication between the research team and CTRC services to ensure operational compliance with Food and Drug Administration, National Clinical Investigator and other federal and institutional guidelines
Reviews and is familiar with all protocols that take place in the CTRC. Works to assure compliance with study related activities performed in the CTRC through protocol binders, training logs and delegation logs
Coordinates with PI’s and study teams and UCH CTRC Clinical Research Staff on administrative issues related to clinical research
Under the direction of the CCTSI Director of Operations, provides leadership, management and oversight to facilitate efficient and effective administrative operations including fiscal, information technology, facilities, personnel, contracts, Clinical Trial Management Systems (OnCore) and infrastructure management
Establishes and maintains high levels of bi-directional communication and collaboration between the CTRC Clinical Trials Support Services, UCD Clinical Research Support Center and UCH Research Support Services regarding issues relevant to active and pending clinical research protocols, patients participating in UCH CTRC clinical research protocols, coordination of support services, etc
In collaboration with CCTSI Director of Operations, the UCH CTRC Medical Director, and the CRSC education team, develops and implements trainings in clinical research for Investigators and their staff
Prepares reports and collects metrics for quality improvement and to support the grant. Also prepares regular reports of actual and projected utilization of the Clinical Trials Support Services
Collaborates with PI’s, UCD CRSC, and UCH RSS in developing accurate projections of protocol related budget items
Collaborates with CCTSI Administrative Director and the CCTSI Director of Operations, in developing accurate projections of expenses, budgetary, and staffing needs relating to clinical research services provided by the CTRC
Works with the leadership of the CCTSI to support NIH/NCATS Network clinical trials including the use of the NCATS SMART IRB model
Serve as the Clinical Trials Liaison to NCATS for UCD
Master’s degree in a health, science or research field
Experience working in an academic institution
Experience with research budget and grant development for sponsored projects
Experience with NIH-sponsored and industry clinical research studies, including multi-center clinical trials
Prior experience as a research coordinator
Advanced knowledge of all aspects of clinical trials implementation including Good Clinical Practices, FDA rules and regulations in relation to clinical trials, ICH regulations, and all other applicable areas of research compliance
Excellent interpersonal oral and written communication, organization skills, and ability to problem solve and multi-task
Knowledge of the academic center regulatory and clinical processes as related to clinical research
Ability to work with physicians and nurses in a clinical research setting
Must be able to work under pressure in a deadline oriented environment

170

Clinical Laboratory Information System Program Manager Resume Examples & Samples

Master’s degree in Laboratory-related Science, Informatics/Information Systems, or Computer Science
Three (3) or more years’ of experience as an Anatomic Laboratory System Analyst or equivalent position
Experience with building or managing Cerner CoPathPlus strongly preferred
Experience with integrating/interfacing an AP-LIS with an Epic EHR environment
Experience with SQL queries and report writing tools
Ability to analyze, evaluate and plan for the information technology support required by an organization in the present and future
Skilled in effective communication with University faculty, staff and students
Demonstrated ability to meet deadlines and to follow through with assignments in a timely and professional manner
Ability to quickly learn and apply new technologies
Demonstrated experience working with diverse populations in a multi-cultural environment that is committed to diversity and equality in education
Must be able to work effectively as part of a team and foster a positive team environment
Proven ability to take direction well and be a motivated self-starter
Experience creating and managing IT policies and procedures
Knowledge of college and university policies and environments

171

Academic Clinical Nephrologist Resume Examples & Samples

Substantial outpatient clinic time
Outpatient chronic dialysis shift(s)
Occasional attending on the inpatient renal consult and hospitalist services
Some holiday and weekend inpatient coverage
Didactic interaction with students, residents, and renal fellow’s clinics
Formal teaching such as attending morning report,
Renal Grand Rounds, clinical conference, and journal club
Attendance and participation at daily educational conferences
Board Certified in Nephrology
Strong medical knowledge in the diagnosis and management of CKD, ESRD, glomerulonephritis, and other common outpatient renal problems
Strong medical knowledge in acute kidney injury, electrolyte abnormalities, and acid-base disorders
Successful completion of Nephrology fellowship training
1-2 years of experience as a practicing nephrologist

172

Clinical Resume Examples & Samples

Directing the didactic and clinical aspects of the advanced education program in Prosthodontics, including recruiting, instruction, supervision and mentoring of postdoctoral students
Preclinical and clinical teaching of fixed, removable, implant prosthodontics, and implant surgery; and
Participation in the department’s intramural faculty practice
Education Requirement
DDS/DMD or foreign equivalent
Master's Degree or Certificate in Prosthodontics from an ADA-accredited dental school; and

173

Clinical Trial Operations Manager Resume Examples & Samples

Strong written and verbal communication and working with global teams - setting clear expectations, ensuring proper follow-up etc
Adept in eDC systems - RAVE
Data Management experience
Effective vendor management skills
Must have high level global experience
Strong interpersonal and communication/ presentation skills (verbal and written)
Ability to handle multiple tasks and to prioritize, strong organizational skills
Leadership & Project Management skills; positive, "can do" attitude, includes effective vendor and stakeholder management, risk management planning, active and effectual oversight of CROs,…
Decision-making and problem-solving skills
Good cross-functional team leader who fosters team spirit and team motivation (team work)
Understanding of database concepts preferred

174

Clinical Laboratory Tech Hmc Resume Examples & Samples

Associates or Bachelor degree in science
Experience in major medical hospital laboratory
Experience with laboratory information system
Ability to communicate effectively in, both verbally and in writing

175

Clinical Application Consultant Resume Examples & Samples

Review and assist customers with their protocols and assays on Ion Torrent / Thermo Fisher instrumentation at in-house facilities and at customer sites
Help customers design, conduct and analyse experiments to assist in evaluations of Ion Torrent / Thermo Fisher products, with strong focus on analysis and interpretation of data
Promote new products (clinical solutions) on customer sites and in conferences/user meetings
Work in collaboration with the Clinical Account Manager to set up best strategy for customer site
Build strong relationships with customers
Maintain consistent and structured communication with counterparts and articulate summarized communication to Manager on a periodic basis
Estimated 30-50% travel,

176

Clinical Trial Coordinator Resume Examples & Samples

Good written and oral communications skills with understanding of written and oral English
Self starter and proactive self learner
Strong knowledge of MS applications including (but not limited to) MS Project, Word, Excel, Powerpoint
Experience supporting teams highly desirable
Provide general administrative and coordination support to the clinical operations department and the development and continuous improvement of departmental procedures
Organize/maintain administrative activities/systems to support department members including compiling, analysis, tracking, filing and other functions as required
Open, sort and distribute mail, fax documents, keep files, order office supplies and maintain supplies
Responsible for scheduling, organizing, and coordinating logistics for on- and off-site staff meetings
Responsible for logistics of meetings with internal and external partners, including scheduling meetings and hosting the visitors
Coordinate agenda for, schedule and organize (including conference dial in) meetings as required
Manage staff calendars, updating monthly schedule, and arrange travel itinerary and related activities
Prepare presentation materials
Schedule interviews for candidates
Conduct additional tasks as may be required by the Clinical Operations Leadership team

177

Financial Analyst, Clinical Solutions Resume Examples & Samples

Personal drive: technical & professional expertise, practice self-development, ability to work in culturally diverse environment, intellectual curiosity
Interpersonal skills: excellent communication skills, collaboration and teamwork, ability to work with different levels of organization, critical & convincing
Drive change: champion change, seek to uncover issues and make improvements
Results oriented: customer focused, drives for results, problem solver, analytical and structured, ability to work to tight deadlines, planning and organizing skills, high level of resilience
Must be a quick study, have excellent business acumen, and be able to react quickly and effectively to changing circumstances
Bachelor's degree in Finance, Accounting or related area
Minimum 3 years relevant experience in an accounting and/or financial analyst role required
Strong analytical skills, a self-starter with "can do" mentality; quick learner in a complex and demanding environment
Excellent knowledge and understanding of financial and management accounting, process and systems
Must be precise and demonstrate strong attention to detail
Affinity with large and complex international working environment
Commercial and organizational awareness, ideally in a comparable industry
Must be an advanced level Excel user. Experience with manipulating large amounts of data and PowerPoint, Hyperion, and Oracle knowledge are required as well as the ability to quickly learn new systems/tools

178

Merchant Clinical Skincare Resume Examples & Samples

Developing and executing overall strategy for growth with new product introductions and strategic expansion of current brands
Establishing and managing brand relationships, inclusive of terms negotiations (margin, testers/damages, training support, co-op, RTV's, samples, and more)
Developing and leading assortment and plan promotions, launches, animations for brands within skincare category strategy
Analyzing all elements of the category to identify areas of opportunity
Sourcing and developing new brands that fill an important need gap within the category
Interpreting and communicating direction to team members within business unit to ensure that each initiative is developed within the desired timeline
Communicating brand and business opportunities to our stores
Leading fixture/plannogram planning and implementation with internal partners
Planning promotions, launches, animations and marketing activities with variety of internal partners
Communicating training needs to brand partners and Sephora education team
Managing brand fill rate and P.O. fulfillment with inventory management team
Constantly developing, mentoring, and training team
Championing a work environment that embodies the Sephora values (teamwork, innovation, expertise, work-life balance, respect for all, initiative, and passion)

179

Clinical Associate Resume Examples & Samples

Provide professional clinical support to new and existing customers (primarily physicians) on our three-dimensional mapping system, Carto 3 inclusive of electro-anatomical mapping. Support on the full BW product portfolio and hardware relating to Electrophysiology procedures will also be required
Act as the first point of contact to Biosense Webster customers for the territory covered
Demonstrate the ability to support the sales target and help manage the defined territory in a thoughtful and strategic manner in collaboration with the Product Specialist
Act as a technical resource through education and training relating to Carto 3, BW products, ablation, and electrophysiology procedures with new and existing customers (primarily physicians, nurses and technologist) in groups and 1-on-1
Build relationships with Key Opinion Leaders and other targeted customers in order to ensure delivery of high quality clinical support and to become an extension of a collaborative field force and Electrophysiology lab team
Technical Qualification in Cardiovascular Technology, RN, PA-C, CNP and/or University Degree preferably in Science or Business is required
Certification through the IBHRE “Cardiac EP for Allied Professionals” will be considered an asset
1-2 years of Clinical experience in the field of cardiology, electrophysiology, cardiovascular care, or medical device industry would be an asset
Willingness to work within a lab or operating room (OR) environment
Candidates must have a valid driver's license
Ability to travel up to 30% is necessary, which may include overnight and/or weekend travel as dictated by the customer and business needs
Candidates must possess superior written and oral communication skills that would allow them to communicate effectively with both technical and non technical audiences
Results and performance driven with a bias for action and sense of urgency on priorities
As driving is an essential requirement of the role, a safe driving record as per Johnson & Johnson SAFE Fleet guidelines

180

Clinical Team Asst-casual Resume Examples & Samples

Staffs all assigned schedules with appropriate personnel
Establishes/maintains work schedules
Process charts, orders, training sessions, team meeting information and other tasks as assigned

181

IC Clinical Resume Examples & Samples

Serves as primary resource for clinical support in the areas of case coverage, basic troubleshooting, specialty product usage and customer training
Educates customers on the merits and proper clinical usage of company products by giving presentations and demonstrations using a wide variety of formats and platforms. Provide supplemental training support during product launches and for high touch specialty products (filter wire / rotablator)
Responds to customer needs and complaints regarding products and service by developing creative and feasible solutions or working with other related personnel to develop optimal solutions (especially training, troubleshooting and general case support for iLab hardware / IVUS)
Previous Cath Lab or Cardiovascular experience
Strong clinical aptitude
Problem solving and the ability to be coached and directed by other teammates will allow collaboration and success in selling IVUS, DES, balloons and the full bag of specialty products

182

Clinical Trial Coordinator Resume Examples & Samples

Develop and maintain positive relationships both internal and external to project, including site personnel
Learn clinical project management processes and therapeutic area basics
Become familiar with and follow appropriate SOPs
Participate in clinical study core team meetings, and record, issue and file minutes of study-specific meetings
Support the CPM in collection of pertinent Regulatory documents from initial trial start-up through trial close out
Ensure central and site file documentation is appropriately tracked and filed, and support the CPM in ensuring that documentation complies with ICH/GCP, BSC and project specific requirements
Reconcile and inventory study documentation periodically and for archiving at study close-out
Utilize specified clinical project systems and tools for documentation management
Assist CPM in completing literature searches and reviews
Support the CPM in development and execution of clinical study contracts and budgets. Report relevant status updates/metrics to the study team as per study-specific requirements
Lead ongoing maintenance of study contracts and budgets
Support the CPM in initiating and tracking IRB/EC submissions, approvals and renewals
Prepare and distribute site Regulatory binders
Track and execute payments to investigational centers and vendors under supervision of the CPM
Initiate study device shipments to and returns from approved sites
Set up SAP for clinical trial shipments
Facilitate investigational device traceability and generate reports as needed
Prepare and ship study supplies to all study clinical trial sites as needed
Support data management and analysis activities as needed under guidance of the CPM
Support protocol adherence through clinical database review and follow-up with clinical trial sites as needed
Identify and Report complaints per Corporate SOP requirements
Ensure timely communication of the need for corrective action at clinical sites or with a BSC process to management
Ensure training (including project specific) is completed per the required timelines and project needs
Assist in implementing process improvement solutions/plans
Other Clinical administrative duties as needed
AA Degree or equivalent work experience in related discipline, Bachelor degree preferred
3 years of related experience, 1+ years relevant clinical experience required
Data related experience preferred
Therapeutic insight with regard pulmonary illnesses (e.g., asthma & lung cancer)
Minimum of 6 months experience in utilizing BSC’s controlled document management systems
Minimum of 6 months experience in administering study site payments (US and OUS) as triggered in BSC’s CTMS environment
The ability to support multiple pulmonary studies simultaneously
Demonstrated ability to maintain and develop clinical study master files for ongoing and new clinical studies

183

Clinical IT Liaison Manager Resume Examples & Samples

Investigates current issues and assists in understanding the impact to field Users IT system changes
Translate between IT and business/clinical teams
This position requires use ability to function at an advanced level in Microsoft Excel and Word and ability to learn additional IT systems quickly
Bachelor’s Degree in related field
Minimum of 5 years of clinical experience in dialysis/nephrology
Advanced level of proficiency in MS Office Suite (particularly MS Excel)
Ability to learn additional IT systems and software quickly
Travel requirement: up to 50 %

184

Senior Analyst, Clinical Programs Resume Examples & Samples

Create, maintain, and distribute reports related to clinical outcomes, surveillance, and risk mitigation on a regular basis
Provide critical insights and data trends to support and inform a multitude of projects and initiatives across the organization
Act as a thought leader and collaborative partner during strategy meetings
Independently drive multiple projects simultaneously
Present data to and work closely with a variety of stakeholders including senior-level operators and teammates in the clinics
Create cohesive presentations based on findings, summarizing insights from analyses
Coach junior analysts and assist in developing their analytical and professional skills
Advanced proficiency in MS Office applications required (MS Excel, PowerPoint, Word, and Outlook)
Intermediate level of proficiency/familiarity with SQL required
Familiarity with more advanced reporting tools (such as Tableau and Cognos) preferred, or willingness to learn
Experience in creating and leading presentations directed towards senior leadership
Knowledge of Business Intelligence and Data Architecture terminology/practices
Ability to quickly adapt to and pick up on new technologies and techniques
Competency in process and performance improvement
Travel required: up to 10%
Bachelor’s degree required; major in biostatistics, statistics, informatics, computer science, math, or relevant field a plus; Master’s degree a plus, but not required
Minimum of 2 years of relevant experience required
SQL, Microsoft Excel, PowerPoint proficiency required
VBA, R, Stata, Matlab, SPSS/SPSS Modeler, SAS, Programming language (Python, C++, C) experience a plus; willingness to learn required

185

Clinical Investigation Tech Resume Examples & Samples

Recruits and screens volunteers for studies
Advertises: following established guidelines and a study budget, creates and places advertising for study participants; helps devise recruitment strategies; explores new methods of participant advertising and recruitment
Screens: following study-specific steps and standard guidelines, answers telephone calls and emails, informs potential participants about the study, schedules screening visits with participants, laboratory facilities, and professionals, reviews screening questionnaires for completeness, scores questionnaires, ensures all screening steps are completed, seeks advice from appropriate study team member on questions related to inclusion/exclusion or appropriateness of participants for studies. May be required to perform clinical tests such as EKGs, vision tests, and/or psychological questionnaires
Schedules: schedules all screening visits for potential participants with laboratories, medical professionals, study investigators; schedules all study-related procedures with participants, investigators, laboratories, and others required to carry out study. Schedules and attends study team meetings, including preparing agendas, taking minutes, etc. Serves as overall coordinator for scheduling all aspects of study
Maintains records: following established procedures, responsible for maintaining screening records for each participant; responsible for maintaining necessary records and documents to meet regulatory (IRB, DHHS, DoD) guidelines. Assists investigators in preparing monthly and annual reports to meet regulatory requirements. Prepares and presents weekly reports for study team meetings
Interacts with human research subjects to administer tests, collect data, ensure adherance to protocol
Physiologic data collection: uses equipment and sensors to collect physiologic signals from study participants following standard or study-specific procedures. Able set up equipment, troubleshoot equipment and sensor problems, download data, with minimal supervision
Biological specimens: collects and prepares urine, blood and saliva samples from study participants for later assay; transports specimens between locations using standard procedures; ships specimens using standard procedures
Performance tests and questionnaires: monitors computer-controlled administration of neurobehavioral tests using central data collection systems; recovers computers after system failures according to standard procedures with minimal supervision. Administers written tests and questionnaires using standard procedures. Administers tests using stand-alone computers and software
Subject monitoring and protocol execution activities: ensures study protocol events are carried out as scheduled in study orders and/or event scheduling system and occur on time while following SOPs; uses data collection systems to collect and record key study information according to CCI, DSCD, and study SOPs; monitors study participants to ensure they comply with study protocol and they remain in good health; communicates any deviations in study protocol, equipment malfunctions, and participant discomfort or complaint to the appropriate CCI, DSCD, and study personnel; provides feedback on areas of workflow improvement and quality improvement
Organizes and processes study data
Creates and maintains databases/files containing study data using standard Division practices
Scores written tests and questionnaires using standard score sheets and criteria; enters scores into worksheets and databases
Compiles data from multiple testing sessions/subjects for data analysis
Reviews study records to determine whether specific tests, samples, or other data were not collected according to protocol, enters such information into tables, edits such information from dataset copies using standard Division practices
Performs statistical and graphical analysis
Assists Investigators and other study personnel in executing studies
Assists in preparation of IRB, CTSC, and other applications, as well as grants
Maintains and orders supplies, prepares equipment, and ensures other materials for conducting studies are available in the correct location at the time needed
Drafts and/or modifies written procedures for study-specific events/data procedures
Carries out standard and study-specific events as outlined in the study orders, DSCD/CCI SOPs, and other written documents
Acts as a liaison between Investigators, hospital staff, CCI technical staff, administrative staff, subject recruiters, and research subjects to identify areas for quality and workflow improvements
Assists Investigator in research activities
Maintains records, keeps inventories, prepares invoices, places purchase orders, and reconciles expenditures and income for specific projects
Performs literature searches, reviews literature, enters papers into reference database, compiles and checks reference lists for manuscripts, grants, and other written reports
Drafts text for reports, manuscripts, abstracts, grants
Assists in orienting and training new employees
Follows Infection Control, Electrical Safety, Radiation Safety and other guidelines as mandated by BWH, OSHA, or other regulatory agencies; follows HIPPA and Human Research guidelines as mandated by DHHS. Follows all standard operating procedures for the Chronobiology Core of the Division of Sleep Medicine, the Center for Clinical Investigation, and BWH; follows study-specific procedures
Performs all other laboratory duties and projects as assigned
Bachelor’s degree in health science, biology, neuroscience, psychology or related area, or equivalent experience preferred
Strongly prefer individual with prior experience working with subjects/patients, and working on a research team
Prefer individual with minimum of 3 months of experience as a technical staff member in the Division of Sleep Medicine, CCI, or equivalent research facility
Prefer individual with independent research experience (e.g., thesis project)
Excellent interpersonal skills, able to maintain positive working relationships with co-workers and to work cooperatively with peers, able to perform his/her role in a team effort
Excellent organizational skills, and ability to prioritize and manage time efficiently
Excellent reasoning skills. Ability to exercise initiative and sound judgment in unexpected situations
Highly competent with using and trouble-shooting computers and equipment
Physically able to assist with the moving of testing supplies and equipment
Willing to accept additional work (new projects, overtime) when required
Ability to continually learn new technical skills and update existing skills
Able to learn and use a variety of software programs
Ability to teach peers, graduate students, post-doctoral fellows, and other researchers technical knowledge and skills

186

Clinical Investigation Technicians Resume Examples & Samples

Coordinates the implementation of research studies both within the BWH community as well as with external vendors, professionals, and stakeholders
Develops, organizes and/or maintains participant information database for study to meet internal (department, Human Research Committee) and external (NIH, FDA, etc.) guidelines and requirements. Required to input and check data, and prepare and present weekly, monthly and annual reports
In conjunction with the Project Leader, develops and prepares materials necessary for the implementation of research protocols including study design, data collection systems, and methods, etc
Responsible for study specific equipment and for assisting Project Leader in testing, setting up, and training other staff on study equipment. Monitors study events and data collection activities during the study
Assists PL(s) in organization, cleaning/editing and analysis of data during and/or following the study
Assist the Principal Investigator/Project Leader with preparation of study generated information for presentations and manuscripts
Ability to work independently in a busy, open office setting with several other employees
Excellent interpersonal skills are required
Ability to learn and understand clinical research protocols and study goals
Ability to maintain good working relationships within the Division and with staff members in other departments
Knowledge of computer programs, database, etc
Excellent organizational skills and ability to prioritize a variety of tasks
Careful attention to detail
Ability to demonstrate professionalism and respect for subject rights and individual needs and to maintain confidentiality
Must be able to be HIPPA compliant at all times
Ability to learn new technical skills and perform them with competency

187

Clinical Performance Analyst Resume Examples & Samples

Bachelors Required in an informatics related field
Masters Preferred in an informatics related field
5 plus years working with complex data environments or systems
Critical thinking abilities
Experience/Understanding with SAS

188

Clinical Performance Assessment & Improvement Director Resume Examples & Samples

Responsible for oversight and assessment of clinical performance data and care delivery practices. Collaborates with administrators, physicians, clinical leaders and staff to identify improvement opportunities utilizing quantitative techniques, knowledge of health care operations and systems thinking. Obtains and uses literature, evidence-based practice and benchmark data whenever possible
Improves clinical performance: identifies causes of variation, serves as a subject matter expert and supports implementation of systems and processes to facilitate effective clinical practice. Leverages results from Peer Review, Regulatory, Patient Safety and others to align performance improvement opportunities with system and local teams
Facilitates prioritization of improvement activities with system and entity leadership. Conducts in- depth assessment of qualitative and quantitative data. Triangulates information to support administrative and clinical decision making. Collaborates with the appropriate process owner(s) to identify opportunities for improvement
Establishes and oversees the development and implementation of annual quality plans with administrative, service line and process owners. Strategizes with entity leadership to plan and coordinate local Quality Councils
Manages and coaches performance improvement activities and oversees projects in collaboration with project leaders and administrators. Serves as a resource and/or facilitates improvement teams to plan, implement, and coordinate entity activities to maximize clinical and operational outcomes. Participates on improvement teams, guiding teams on system defined improvement methodologies and processes
Maintains clinical performance assessment, performance improvement, change management and project facilitation expertise through independent study, internal development courses, attending education workshops, reviewing professional publications, establishing personal networks, and participating in professional organizations
In some settings, responsible for recruiting, selecting, developing, mentoring, supervision and assessment of staff. Also responsible for creating and managing departmental budgets

189

Clinical Delegation Oversight Auditor, Senior Resume Examples & Samples

Review of clinical functions and collaborates with other departments and/or delegated vendors to direct clinical compliance issues to appropriate channels for investigation and resolution. Consults with management, in-house counsel, delegated vendors, and/or the VP of Regulatory Compliance as needed to resolve difficult compliance issues
Regular interaction with all departments, management, associates, delegated vendors, and/or regulatory agencies regarding compliance issues
Review and evaluate the effectiveness of corrective action plans that address audit report findings and provide comprehensive follow-up to Senior Management, market Compliance oversight Committees, and/or the Regulatory Compliance Committee of the Board of Directors
Track the status and completion of all corrective action plans and ensure the implementation of all recommendations derived from each focused review, oversight and/or monitoring activity
Evaluate the effectiveness of various compliance programs and related policies and procedures designed to promote legal and ethical compliance
Identify and assess compliance risks within the Company and/or with the Company’s delegated vendors
Serves as a compliance advisor to various business units or delegated vendor
Participates in the ongoing development of educational and training tools for the Compliance Program that seeks to ensure all associates are knowledgeable of and comply with pertinent Federal and State laws and regulations
Assists with the development, initiation, maintenance and revision of Compliance Program policies, procedures and practices for the general operation of the Program
Assists Corporate Audit & Oversight management with the development and execution of key departmental initiatives
May participate in special projects as needed including auditing, training, and HIPAA compliance
Communicates the importance of compliance and the compliance program to health plan staff and/or delegated vendors, which includes promoting (1) increased awareness of the Corporate Ethics and Compliance Program, (2) understanding of new and existing compliance issues and related policies and procedures, and (3) importance of oversight and monitoring activities
This position serves to educate, encourage and assist those within the Company and with the Company’s delegated vendors to maintain integrity through oversight and monitoring and in meeting the requirements of the Annual Work Plan within State Medicaid Programs, OIG and CMS work plan requirements
Provides education and training about laws and regulations that affect operations internally and/or through delegated vendor relationships
Provides guidance, direction and mentoring to lower level staff members
Performs other duties as may be assigned
LI-RR1
Required An Associate's Degree in Nursing, Pharmacy, or Other Clinical related discipline and a Registered Nurse (RN), Licensed Vocational Nurse (LVN), Licensed Practical Nurse (LPN), or Licensed Clinical Social Worker (LCSW) designation
Preferred A High School or GED Business, Public Health, Health Care Administration
Required 5+ years of experience in Managed Care/Health Insurance
Required 2+ years of experience in a project oversight type role with demonstrated ability to drive implementation and influence others
Required 3+ years of experience in Experience in State Medicaid or Federal managed care compliance
Preferred Other Previous experience managing compliance issues via audit/compliance platforms
Intermediate Knowledge of community, state and federal laws and resources
Required Licensed Vocational Nurse (LVN)
Required Licensed Specialist Clinical Social Worker (LSCSW)
Required Intermediate Microsoft Project
Required Intermediate Microsoft Access
Preferred Intermediate Healthcare Management Systems (Generic)
Required Intermediate Microsoft PowerPoint

190

Clinical Educatior Resume Examples & Samples

Assesses, plans, directs and evaluates educational needs for the clinical care area(s) assigned
Provides educational programs based on the needs identified in the clinical care area
Develops/modifies the clinical orientation program of all new nurses, including cross training to the different areas as designated
Ensures that the educational needs of all shifts are addressed. Ensures competency of staff by serving as resource by assisting in the development of individual nurses to maintain staff competency
Assists nursing staff with assessment of patient/family care/educational needs on selected cases and collaborates with nursing staff and other health care professionals to meet identified needs
Participates in the development/evaluation of Patient Education/discharge planning aspects of care
Assists with the development and implementation of nursing intervention and patient care strategy
Utilizes knowledge of the developmental levels of the patient and age related factors in order to support staff through education to care for these patients. Interprets, evaluates and communicates pertinent research findings to nursing staff through in-services and scheduled programs regarding issues in Patient and Family Care
Presents formal and informal education to the nursing staff, patients and family in clinical setting
Presents classes related to clinical specialization to staff, students and other health care professionals as needs are identified
Encourages the use of and integrates online education
Ensures the education requirements for Governing Board/Regulatory Agencies are met
Collaborates with Nurse Directors, Infection Control, Quality Improvement Director, physicians, and other health care professionals to identify educational needs and provide online education support to clinical staff
Serves on other committees or task force
Participates in professional organizations in order to expand knowledge base and develop professional contacts
Education experience for approximately 2-5 years
Minimum of 2 years of nursing specialty experience required, with the ability to apply theory related to practice and performance of required technical skills
Experience in the development of educational programs required
Working knowledge of Quality Improvement process and Joint Commission standards
Able to relate to a large variety of individuals
Clinical and operational experience in the respective field or specialty
Physical Requirements: Ability to work at a fast pace and to prioritize multiple assignments/projects and respond to numerous requests; ability to resolve conflicts among staff and to work collaboratively with department director, physicians and other members of the healthcare team; ability to ensure operational efficiency; ability to problem solve and make decisions; ability to exercise self-control and tolerate stress when dealing with multiple requests and/or conflicting demands from multiple customers
Needs minimal sustained direction in assessing needs, directing staff and carrying out departmental and professional responsibilities; self-starting and self-motivating; working hours may exceed eight hours per day and is based on what is needed to accomplish work at hand
Able to be flexible with time

191

PA Allergy, Asthma & Clinical Immunology Resume Examples & Samples

Collaborates with referring physicians to provide comprehensive, seamless care to patients in the outpatient setting
Performs comprehensive histories and physical exams, identify normal and abnormal findings, including physical, cognitive and psychosocial status
Partners with providers to plan and implement therapeutic regimens including nursing and medical management strategies
Establishes systematic follow-up for evaluation of the plan of care and reassess as necessary
Assures family and patient teaching is adequate to manage the plan of care at home
Functions independently in an outpatient clinic setting
Strong Internal Medicine experience
Excellent verbal, written and oral communication skills

192

Clinical Laboratory Technologist Resume Examples & Samples

A two-year commitment to this position is required.**
The required credits necessary to meet New York State guidelines pertaining to clinical testing must be met prior to graduation**
CV/Resume
Transcripts (unofficial copy accepted)

193

Senior VP Clinical & Formulary Services Resume Examples & Samples

10+ years of clinical and/or managed care pharmacy experience
10+ years of leadership experience including managing leadership levels
5+ years of extensive involvement in clinical pharmacy strategy
5+ years hands on experience with P&T and Formulary Management
Pharm D
Advanced degree/ MBA
Pharmacy Benefits Management experience

194

Clinical Analytical Consultant Resume Examples & Samples

Efficiently extract and manipulate pharmacy claim data for internal and external clients
Collaborate with the clinical account management team and other internal departments to support the analytic needs of one or more clients
Design, execute, and maintain advanced PBM analytics, conduct and evaluate trend analyses, and present clinical and financial opportunities based on analytic insights to clients
Use logic and analytic skills to perform client analyses in response to specific business questions and communicate the findings, including data sources, methodology, outcomes and recommendations
7+ years of experience in quantitative analytics, conducting advanced analytic modeling for large claims databases with real - world application
5+ years of experience working with administrative pharmacy and medical claims data
1+ year of experience working in PBM and / or managed care
Experience preparing and giving formal presentations to clients
Proficient computer skills including in Microsoft Outlook and Office
Master’s Degree in Math, Statistics, Engineering, Computer Science, Public Health, Health Economics or a related quantitative field
Experience working with State governments contracts or large employer groups

195

Director of Optum Clinical Capability Management Resume Examples & Samples

Partnering closely with executives to understand enterprise clinical business and platform needs and proactively develop solutions to meet their needs
Understanding Optum business models, underlying business drivers, applicable industry and market needs
Providing innovative solution design and business architecture expertise and recommendations to solve complex business problems and deliver value. Acts as subject matter expert on Optum clinical capabilities and provides oversight on work in those areas to ensure we are not creating unnecessary, duplicative solutions
Collaborating with business and technology partners to determine priorities
Establishing and maintaining effective communication channels to ensure the customer and solution team is kept abreast of any key changes in strategy or solution direction
Partnering with finance and business operations leaders to complete capital planning activities and Cost Benefit Analysis deliverables (includes identifying cost avoidance, cost reduction opportunities)
Defining and managing strategic roadmaps for key Optum clinical capabilities
Leading capital projects supporting enterprise clinical initiatives from end to end (ideation through implementation and deployment). Ensuring successful execution on all responsible capital work streams and work streams that are impacting capabilities and platforms and overseeing the entire software development lifecycle
Managing a team of business analysts and project managers to support the execution of the clinical platform builds. This includes research & analysis, business requirements, design work, testing, deployment and support. May also include defining operational support for new capabilities including, governance, business operations team definition, steering and funding strategies
This position is located in Eden Prairie, MN
Leader with 12 + years of demonstrated progressive accomplishment in the following areas

196

Clinical Product Analyst Resume Examples & Samples

Investigates non-standard requests and problems, with some assistance from others
Works exclusively within a specific knowledge area
Serves as product subject matter expert and liaison for internal staff and external customers
Serves as liaison for strategic initiatives crossing business teams and operating groups to coordinate and complete product and business development initiatives
Works to further establish processes and structure within our existing business unit to help create efficiencies within our products
Investigates processes and problems by leveraging data and facts, identifying the key team(s) to solve problems or create processes, and documenting clearly and concisely
Monitors and measures effectiveness of product and strategies and provide recommendations to adjust as necessary
Develops and implements new programs and processes
Bachelor's Degree in Business, Finance, Communications, or Marketing
4 years of product management experience within a matrix organization
2+ years of experience in tracking, planning projects, working with large data sets
2+ years of Product Development experience
Demonstrated ability to manage and prioritize deliverables
Intermediate level of proficiency with MS Project, Excel, Visio, PowerPoint and SharePoint
Experience with project management and complex projects and activities
Strong background and / or understanding of the healthcare industry
Knowledge and experience with the Health Care industry
Strong focus on execution and delivery
Excellent time management skills with the ability to self-manage according to priorities
Strong problem solving skills, ability to translate complex to easily understandable actionable terms
Ability to thrive, quickly adapt to change - and lead others through change - in a dynamic, fast-paced industry and matrixed work environment
Exceptional interpersonal, social and conflict management skills
Demonstrated effectiveness building strong relationships with inter-company divisions

197

Director of Clinical Resume Examples & Samples

At least 5-10 years of experience in the behavioral health field inclusive of at least 5 years in an inpatient facility;and a minimum of 3 years management experience
Experience in providing project management in multiple facilities or programs simultaneously
Demonstrated leadership ability in the areas of initiating program assessment and implementing quality program evidence-

198

Clinical Risk Manager Resume Examples & Samples

Two to five years experience within a hospital risk management with a focus on patient safety, risk management or quality improvement. Experience and/or demonstrated understanding of root cause analysis and FMEA analysis
RN preferred or other Clinical/Hospital background to provide for appropriate investigation of clinical events
BS required
Strong interpersonal skills, ability to work across disciplines
Ability to analyze data, formulate meaningful information
Ability to work with highly sensitive and confidential information with appropriate discretion
Training in patient safety or risk management and quality/performance
Improvement methodology, concepts, education and implementation
Membership and active participation in professional organization(s)
MS or JD preferred
Certified Professional in Healthcare Risk Management (CPHRM), preferred

199

Clinical Fellow, Speech Pathology Resume Examples & Samples

Master's degree in Speech Pathology from an accredited program of speech language pathology
Current California Speech Language Pathologist license or temporary license preferred
Minimum level of experience: new graduate
Must have one continuing education course for each year of practice
Must have manual and physical skills to perform high quality patient care with patients of any weight or age with multiple diagnoses

200

Clinical Trials Budget & Coverage Analyst Resume Examples & Samples

Must have two or more years of experience in clinical research administration or financial management
Must have one or more years of experience with budget negotiations for industry sponsored research
Two or more years of experience in human subjects’ protection regulatory analysis is desired
Certification in medical coding is desired
Experience with EPIC is desired
Must have knowledge of Centers for Medicare and Medicaid Services (CMS) Clinical Trial Policy, Medicare benefit categories, statutory exclusions, national and local coverage determinations and of national medical practice guidelines, Food and Drug Administration investigational drug and device research
Must be knowledgeable about medical coding, protocol visit span allowances, protocol-specified clinical services, and clinical research financial activities and documentation required before study initiation, including research protocol, internal budget, sponsor contract and budget, and consent template
Demonstrated budgetary and strategic planning experience and responsibilities
Demonstrated resourcefulness and meticulous attention to detail
Proven ability to work effectively with both technical and non-technical personnel
Demonstrated excellence in written, oral, electronic communication and presentation skills; scientific writing skills desired
Able to use multiple technical systems as intended; ability to collaborate across revenue cycle, compliance, and research operations teams
Ability to review complex documents independently and/or in collaboration with research administrators, and determine sufficiency of financial documentation
Ability to conduct research independently to identify and document evidence of medical necessity and federal billing status of clinical trial protocols
Excellent analytical, budgeting and computer skills, including Intermediate/Advanced Excel skills
Requires ability to work independently and to accept responsibility for complex and sensitive decision-making as it relates to the position
Must have outstanding organization skills to manage competing timetables and responsibilities

201

Clinical Finance Operations Analyst Resume Examples & Samples

Bachelor’s Degree in accounting, finance or related business discipline
2 years of professional work experience
Excellent communication and facilitation skills
High level of collaboration and teamwork proficiency
Proficient with Microsoft Outlook, Word, Excel, PowerPoint, and Visio
Understanding of multi-dimensional databases and related data extraction
Proven analytical approach to problem solving and decision making

202

Clinical Decision Resources Lead Resume Examples & Samples

A minimum of an advanced degree (e.g., PharmD., MPH, MD) is required
A minimum of 6 years of relevant experience in Medical Information with strong communication (written and presentation) skills or experience with a drug Compendia is required
Understanding the uses of evidence-based medicine, comparative effectiveness, drug compendia, and care pathways for health care decision-making is required
Expertise in the healthcare industry, clinical knowledge or practice across multiple therapeutic areas is strongly preferred
Working knowledge of United States health care systems and payers - specifically understanding business models and perspectives of managed care and public sector - is preferred
Demonstrated excellence in leadership, including

203

Clinical Protocol Developer Resume Examples & Samples

Knowledge of medical terminology and treatment concepts
Understanding of national regulations regarding human subjects research
Understanding of AAALAC and USDA regulations regarding animal subjects research
Demonstrated ability to interact professionally and effectively with investigators, sponsors and cross-functional teams
Previous experience clinical trial protocol writing and editing
Knowledge of complex regulations, policies and procedures concerning the conduct of clinical trials, including FDA Good Clinical Practice (GCP) and IND requirements
Adept at intermediate level biostatistics
Knowledge of scientific writing, presentation and manuscript presentation
Will complete human subject protection training developed by the Collaborative Institutional Training Initiative (CITI), and NMCP research integrity training within one month from start date

204

Clinical Service Manager Resume Examples & Samples

Responsible for supervision of NPs and PAs in skilled nursing facilities in Western Washington and the Greater Puget Sound area
Building self-directed work teams with autonomy and accountability for their own goals/targets
Supporting and promoting organizational goals into specific goals and objectives for clinical staff
Developing and conducting programs that support and improve quality management and clinical performance of the Optum CarePlus clinical model in our partner skilled nursing facilities
Oversight and performance various administrative/operational functions to support the team
Providing clinical/health services expertise on business development efforts
Developing/strengthening relationships with various stakeholders
Analyze caseload assignments and make adjustments to shift assignments as needed
Promote collaboration among clinical and non-clinical staff
Strong supervisory, management and leadership skills
Certification as a GNP, ANP or FNP, or ability to obtain
Experience with electronic documentation and coding
Frequent Travel to facilities within territory
Current, unrestricted NP license in the State where position is located, or ability to obtain
Previous NP Supervision experience
Prior long term care NP experience

205

Clinical Standards SME Resume Examples & Samples

Reviewing the Study Reports, Report to Study Director for any discrepancy related to some discrepancy
Mapping of Raw Data (PDF Format) in CDISC SEND standards
Generation of Trial Design Domain (TA,TE,TS,TX)
Generation of PC-PP domain, This is completely done Manually
Mapping variables to controlled Terminology
Send Data-set generation
Validation and fixing errors and warnings in SEND domain
Preparing the Study Data Reviewers guide for the study
Generation of Define.XML
Placing the complete study package in eDOCS
Submitting the study package to Submission Operations (Regulatory)
Finally uploading the package in vDOCS with cover letter to Regulatory
Handling with multiple CRO and evaluating validation on their Study package
Reviewing CRO Data
Communication with CRO and Product Vendor

206

LTC Field Clinical Assessment Specialist Resume Examples & Samples

Identifies applicant's health needs and completes medical assessment of applicant
Coordinates with Care Management team and provides updates regarding member health status
Valid Drivers license may be required
Required An Associate's Degree in Nursing or related field
Required Other Current case management experience
Intermediate Ability to multi-task Ability to work independently, handle multiple assignments and prioritize workload

207

Clinical Team Leader Resume Examples & Samples

Regulatory Documentation - Independently resolves protocol questions with the Project Manager (PM) and patient related issues with the Medical Monitor (MM). Maintains a record of all contacts with the PM or MM concerning protocol deviations and clarifications
Monitoring - Develops clinical plans and guidelines, including clinical monitoring plans. Assures compliance with monitoring intervals according to the project requirements. Responsible for identifying best practices (geographically and therapeutically) within clinical monitoring and developing communications and training tools for the organization. Typically acts as Lead CRA on studies that are often larger or more complex global projects and programs
Line Manager - Responsible for the supervision and administrative oversight of all direct reports, which are most commonly CRAs and could include less experienced CTLs. Develops training plan and assures training compliance for all direct reports. Develops training plan and assures training compliance for all direct reports. Evaluates strengths/developmental opportunities of staff members. Evaluates and advises on strengths/developmental opportunities of staff members. Sets clear goals and objectives for all direct reports. Completes performance reviews and implements performance plans. Ensures CRA and CTL metrics are met. Meets regularly with direct reports to mentor them and to evaluate workload and metric compliance. Provides data for the maintenance of resourcing tools. Collaborates with study leadership/management to identify project resourcing demands, resolving potential resourcing conflicts and facilitating mutually beneficial resolutions. Meets and provides feedback to management on areas for process improvements and participates in process improvement teams. Evaluates staff's competency to perform on-site visits independently via sign-off visits according to published requirements. Participates in interviewing, collaborates with HR/Training in assessing initial training needs, and orientates new hires into the team and function. Facilitates teamwork; influences and motivates team to accomplish goals by encouraging direct and open communication, resolving conflict, and demonstrating support to team members. Ensures required on-site CRA assessment, sign-off, and documentation occurs. Provides strong leadership to the team, encouraging engagement, innovation and open communication, while implementing Company procedures

208

Clinical Ambassador Resume Examples & Samples

Responsible for providing consistent and effective updates to the Vice President of Clinical Services for all assigned responsibilities
Responsible for Oversight of Clinical and Regulatory Operations to include in-direct supervision of facility department heads
Responsible for Oversight and Performance Management of the Company’s Risk Monitoring effort with focus on specific regions including but limited to the following areas
Responsible for collaborating on clinically oriented census development opportunities (i.e. Clinical product development) and expense reduction opportunities (i.e. pharmacy reductions) in conjunction with the district/region operating teams
Responsible for implementing all Company Clinical and Regulatory Strategic Goals, including new or revised company systems, policies and procedures and programs
Monitors and encourages achievement of goals and objectives consistent with established company philosophy and standards of practice. Responsible for providing executive clinical leadership to certain defined operations ensuring an effective Quality Improvement Process with favorable clinical trends
Conducts Focus Compliance audits and Corporate Clinical Services Compliance audits as assigned
Regularly and consistently reviews clinical performance trends and indicators to identify trends. Provides necessary clinical leadership to address all unfavorable trends and outcomes

209

Clinical Risk Manager Resume Examples & Samples

Bachelor’s Degree in a Healthcare related field and four (4) years of experience in a clinical discipline or Associate’s Degree in a Healthcare related field and six (6) years of experience in a clinical discipline or RN if less than at the Bachelor’s Degree level and six (6) years of experience in a clinical discipline
TX RN license if an RN
Certified Professional in Healthcare Risk Management (CPHRM) preferred

210

Clinical Configuration Specialist Resume Examples & Samples

Resolution of customer issues both remote and on site
Serve as field liaison with sales, marketing, and service organizations on customer-related product issues
Development and support of the physician clinical reports within the application
Participate in process improvement methodologies for training delivery
Support team and business Initiatives and comply with GE Policies
100% compliance with GEHC implementation documentation requirements
Conduct on-site and remote clinical applications training to ensure the customer can effectively use the product to maximize their productivity
5 years of clinical expertise focused primarily on diagnostic imaging
Background in digital diagnostic imaging workflow, including RIS and PACS
In depth knowledge of PACS implementation methodology and possesses the ability to translate this in support of a successful implementation
Highly knowledgeable of the Centricity PACS architecture and theory of operation
Excellent verbal and written communication skills, including the ability to effectively facilitate training/presentations
Ability and willingness to travel extensively 70% to 90%
Highly skilled in the utilization of Microsoft VISIO, Project and Office Professional components
Willingness to learn and support additional products within ITPS
Cardiology software knowledge / Experience
Bachelor’s degree in business administration/related field
In depth knowledge of GEHC IT products in the Radiology space
Effective organizational, assessment and planning skills
Strong interpersonal and team leadership skills

211

Clinical Study Director Resume Examples & Samples

Medical reference and medical expertise for operational strategy within the CSO for study registries he/she is allocated to
Medical consultant for projects to be proposed to the CSO
Medical contact for interaction with physicians responsible for the project or the study at the customer level
Support with his/her medical knowledge and background a study or a project from
Business negotiation with customers to final product delivery \(e.g. study completion or
Project report or publication\)
Conduct the feasibility for study/project with the feasibility manager and other team members $especially Medical Advisors in CSUs$
Prepare and/or organize and/or participate to Investigator’s Meetings, Steering Committees, Data Monitoring Committee meetings $only “open” part of the DMC meetings$
Prepare and/or approve any documents related to the study and requiring a medical expertise $extended synopsis, protocol, medical training material for study monitoring team and for investigators$
Provide medical training to study team, CSUs $Medical Advisors, monitoring$ and investigators
Develop interaction with Medical Advisors in CSUs for the best knowledge of the study, compound protocol
Participate to Investigators meetings
Provide medical answers to questions from Health Authorities, IRB/Ethics Committees, investigators, experts
Participate to clinical trial team $and cluster if any$ meetings
Accountable for the medical review of data done by the clinical trial team, the case by case review of safety events reported to GPE and coding of events and drugs
Provide appropriate medical input for patient recruitment and retention strategy
Support the CSUs and affiliates to develop network of KOLs and experts and to select National Coordinators or members of Study Committees
Prepare and provide key medical information to investigators and/experts in respect with communication policies $e.g. study results, DMC advice$
Feasibility results with feasibility managers
Project/Study deliverables with the Clinical Study Team
Operational strategy with Project Leader $s$
Get support from the Unit Management Office to get appropriate medical staff in CSUs and to determine appropriate study budget according to medical considerations
Collaborate to Adjudication Committee Review including prior patients’ data review as needed
Ensure high quality execution from a medical perspective with support of all functions &
Quality & Continuous Improvement group
Ensure appropriate documentation and investigations of safety cases with Global
Pharmacovigilance and Epidemiology $GPE$
Ensure high quality of coding with coding officers
Licensed United States Medical Doctor or an International medical graduate who has certification by the Educational Commission for Foreign Medical Graduates $ECFMG$
2-3 or more years of Phase 2/3 Clinical Research / Drug Development experience in the pharmaceutical industry
Knowledge in ICH, GCP and local regulations
Fluent in English $writing and speaking$
Additional Clinical Research and/or Drug Development experience in other therapeutic areas, especially Cardiovascular and Metabolism

212

Clinical Trial Operations Manager Resume Examples & Samples

Provide oversight of a study to ensure progress according to study timelines
Strong interpersonal and communication skills (verbal and written)
Project Management skills
Strong verbal and written English skills
Must be able to interact effectively with a variety of internal and external teams
CTOM will consult with the DPE/PL to ensure study decisions are aligned on program timelines, strategy and budget

213

Clinical Trial Document Specialist Resume Examples & Samples

Accountability to study Project Managers, or equivalent, for assigned global eTMF responsibilities sponsored by a Core Bard Division or International Business Center
Establishment and maintenance of a quality-focused partnership, with proactive provisioning of crucial TMF quality support to the study team from start-up to close-out
Provide real-time, constructive feedback, education and best practice demonstrations to promote user adoption and build a knowledge and awareness of GCP, GDP and associated processes
Oversee and manage essential document collection, including the timely and risk-based review and maintenance of eTMF content
Apply an integrative approach to eTMF quality management through efficient and judicious use of Clinical Trial Management System (CTMS), Oracle Remote Data Capture (RDC) and J-Review
Ensure documents are scanned, imported, classified and QC reviewed within eTMF on a daily / on-going basis
Conduct and/or assist in periodic inspection readiness exercises, internal audits and regulatory authority inspections
Represent C.R. Bard in the TMF Reference Model Project Team, and become an active influence for medical device requirements on relevant initiatives and working groups
Assist in training internal and external team members on Bard’s TMF configuration(s) and eTMF process and procedures
BS / BA / BSN or equivalent 4-year degree, preferably in a related scientific field. Associate degrees and technical certifications will be considered with strong, relevant prior experience
Thorough working knowledge of clinical trial methodology relating to the monitoring of clinical trials, GCP, FDA, and / or country specific regulatory environment
1-3+ years of demonstrable, global TMF ownership spanning multiple indications
Experience working with eTMF software platform(s)
Experience working with Clinical Trial Management System(s)
Experience working with EDC system(s)
High to expert proficiency in MS Office Suite of products
Excellent interpersonal, administrative, verbal & written communication skills
Ability to work independently, at times with minimal supervision
Strong working knowledge of clinical trial design, execution and analysis methodologies
Ability to influence positive results in the absence of formally delegated authority or line management
Strong time management and prioritization skills to provide high quality deliverables while supporting multiple concurrent projects
Strong organizational skills, detail oriented
Medical Devices
Veeva Vault eTMF, Investigator Portal, Study Start-Up, Registrations, Submissions, QMS and/or Quality Docs
BioClinica’s OnPoint CTMS
Oracle RDC
J-Review

214

Clinical Project Operations Manager Resume Examples & Samples

Support study lead and line functions with the development of trial budget and financial strategy, and assist with securing approvals
Systematically estimate the life-time costs of all relevant studies and work with all stakeholders to ensure that this estimate is of high quality
Ensure budgeting systems are accurate regarding financial forecasts, expenditures, and internal resource planning
Identify issues and propose mitigating plans for facilitating decision making
Support the Clinical Project Management Group Leads in actively monitoring adherence to budgetary targets including management reporting with variance analysis, proposals for corrective measures and decision support
Provide financial training to Clinical Project Management and clinical trials team as required
Develop best practices for allocating and managing resources
Improves and enforces compliance with business and financial control processes
Ad hoc financial analysis to support CPM group leads and PLS Finance as required
Advanced degree or equivalent education/degree in life science/healthcare is required
Fluent English (oral and written)
6+ years Clinical Operations experience with at least 4 years managerial experience in planning, executing, reporting and publishing clinical studies
Proven ability to work independently in a complex matrix environment (including remote)
Proven experience in managing clinical trial budget
Excellent communication, negotiation and problem solving skills
Strong customer oriented mindset and independence
Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory process-es, and global clinical development process

215

Clinical Project Operation Manager Resume Examples & Samples

Support study lead and line functions with the development of trial budget and financial strategy, and assist with securing approvals. Contribute to quarterly trial budget review meetings
Systematically estimate the life-time costs of all relevant studies. Contribute to the original phasing of life-time costs for the studies and subsequent updates. Work with all stakeholders to ensure that this estimate is of high quality
Ensure budgeting systems are accurate regarding financial forecasts, expenditures, and internal resource planning. Coordinate generation of consolidated latest estimates on current year budget vs. originally planned and model potential impact on future year budget planning
Challenge and track project(s) resource requirements, expenditures and revenue target
Identify issues and propose mitigating plans for facilitating decision making. Liaise with relevant line functions (e.g., PLS finance, Pricing, Clinical Project Management) regarding financial deviations and forecast
Provide financial training to Clinical Project Management and PLS staff as required
Develop best practices for allocating and managing resources. May participate in or lead cross-functional process improvement initiatives
Significant Clinical Operations experience with managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organisation
Proven experience in managing clinical trial budget. Ability to address budget review question and reconcile planning with actuals, be it with customers, service providers and PLS finance
Demonstrated presentation and diplomacy skills. Negotiation and conflict resolution skills

216

Clinical Trial Leader Resume Examples & Samples

Lead the clinical protocol development process in collaboration with the Clinical Program Leader (CPL): responsible author for clinical protocols, amendments and related documents; contribute to the medical/scientific input given for the development of trial-related documents and processes which reside in other line functions; obtain approval from internal review boards. Collaborate with the Medical Directors of the Novartis local organizations (CPOs) and investigators to ensure their feedback is adequately integrated into protocol
Contribute to the development of clinical sections of regulatory documents like Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions
Investigator/site relationship management is vital; must develop effective working relationship with key investigators in assigned therapy area to optimize scientific quality/innovation of clinical study design, execution, reporting and publication. Contribute to trial-related advisory boards. Lead investigators meetings. Lead protocol training meetings and support CPOs in the conduct of regional meetings. Accountable for all internal clinical meetings related to the clinical trial(s)
Lead and matrix manage the global multidisciplinary CTT to ensure all trial deliverables are met according to timelines, budget, and resource requirements; speaks up against unrealistic timelines. Energizes CTT to adhere to global performance and quality standards: chair CTT meetings, report study progress and issues with their resolution plan. Engages the input of line functions at the appropriate time. Leads trial level interactions with Global Monitoring Operations (GMO) and other relevant functions including Integrated Medical Safety and Drug Supply Management
In collaboration with the CPL lead the clinical trial data ongoing medical/scientific review, final analysis and interpretation including the development of clinical trial reports, publications and internal/external presentations
Prepare and run dose escalation meetings with investigators. Coordinate the real time availability of quality clinical trial data, including safety, efficacy, pharmacokinetic, imaging and biomarker data, to provide consolidated information for dose escalation meetings with investigators
Forecast trial resources needs (external costs): accountable for the development, management and tracking of trial budget working closely with CRO Management, with Clinical Trial Budget Managers and TCO Global Program Managers. Accountable for accuracy of trial information in all trial databases and tracking systems
Sits on Early Program Team (EPT) to contribute to program strategy
Ensure that program specific standards (e.g., CRFs, outsourcing specifications including imaging, biomarkers PK, data monitoring, validation plans and data transfer specifications) are applied to the clinical trial, where applicable
Develop clinical outsourcing specifications to facilitate bid templates and selection of CROs and other 3rd parties including central lab and imaging vendors; manage interface with external vendors in cooperation with the CRO Management Department as well as with the Assay Research Lab. This also includes the set-up, logistics, documentation and clinical supplies needed for the clinical trial(s)
For TCO trials led by a US-based clinical trial leader, function as local trial leader (LTL) for all US activities including working closely with US GMO for all study start-up activities including regulatory documents, budget, contract agreements and all activities pertaining to updates as dictated by amendments. As the LTL be the primary contact for US sites for clinical conduct of the trial
May participate in the on-boarding and mentoring of new TCO staff
Contribute to the implementation of best practices and standards for trial management, including sharing lessons learned

217

Clinical Trial Leader Resume Examples & Samples

Collaborates with the Global CTL in the development of various components of the operational plan including country allocation, site identification and selection, recruitment, study closeout, outsourcing, investigational product management, data review, and budget that are consistent with standard process and guidelines, including contingencies and implement actions as needed
Accountable for all local (US) project timelines and deliverables. Evaluates and communicates the probability and impact of risk, develops quality and risk management plans for performance and ensures this is integrated into the overall plan for the monitoring management project deliverables in accordance with the project plan
Accountable for the quality of the clinical trial execution in partnership with management, CQA and other key stakeholders. Provide operational input into protocol development, study-related documents (including, but not limited to Site Management Oversight Plan, CRO Monitoring Plans, etc.) to ensure efficient and effective delivery of trial objectives
Actively participate in vendor selection process from Request for Proposal (RFP) through final contract
Prepare and provide input into materials for Investigator Meeting and Monitors Training Meeting, as well as plan and execute the coordination of US Investigator Meetings
Manage, oversee or participate in the preparation and/or review process of trial-specific documents (e.g., Protocol, Amendment, Clinical Study Report, etc.), and support the generation of trial-specific clinical documents
Establishes and maintains strong communication across the matrix and build successful relationships with key US stakeholders, Global stakeholders and external vendor personnel. Proactively provides status updates keeping stakeholders informed and up-to-date on trial deliverables
Participate in the development of trial specifications (including user acceptance testing) with vendors and appropriate line function input to ensure the capture of quality data as per protocol requirements
Active leadership to local project teams
Coordinate, facilitate, and maintain trial-level training focused for US Clinical Trial Managers (CTM) (blinded and unblinded, if applicable) and Clinical Trial Specialists (CTS) assigned to the trial
Consistently utilizes well-defined processes for documenting and organizing work within their trial team

218

Clinical Sciences Multi Resume Examples & Samples

Provide updates to regional and/or Global head and NIBR management as re-quired
Holds group specific responsibilities, which may include administrative duties, staffing/hiring, local considerations, local process improvements, use of new tech-nologies and innovation and other responsibilities as assigned
May act as a Lead Clinical Scientist for an assigned project with responsibility for providing or coordinating project level documentation, regular project updates and implementation of the NIBR portion of the Clinical Development Plan. May serve as a study lead depending on the workload and extent of a project. Deputizes for local study leads as required. 8. Contributes, as requested, in the identification, evaluation and appropriate training of new centers suitable for studies/patient populations
Assist in the recruitment and training of all new CS&I staff into their group. En-sures on-boarding and mentoring plans are in place prior to their start date to facili-tate rapid and successful integration into the team
Build a strong, diverse team, develop talent including potential successors, and contribute to a highly productive organization that balances operational efficiency and delivery with scientific insight and innovation
May function as a liaison to other Line Functions (e.g. Drug Metabolism & Pharma-cokinetics (DMPK), Biomarkers) ensuring relevant skills (e.g. PK, clinical imaging) are developed and maintained within the local group
Experience in multiple clinical indications and/or therapeutic areas preferred
Capable of clear written and verbal expression of ideas, an active/proactive communicator
Ability to interact with a wide range of people and build strong positive relationships and lead cross-functional initiatives

219

Clinical Performance Consultant Resume Examples & Samples

Work with Marketing, R&D, Implementation, and GCS leadership to ensure business and training strategy alignment
Work closely with GCS Education Services Managers and other team members to guide the development of clinical educational materials and review content for clinical accuracy
Maintain a high level of knowledge of Medical Systems products and stay informed about upcoming product releases
Assess clinical and workflow impact of new product releases and translate information into educational materials
Facilitate customer and employee clinical and product training in person or using web-conferencing technologies
Facilitate clinical workflow assessments and optimization engagements to enable customer product utilization
Facilitate customer engagement and communication initiatives; assist in determining business and/or customer needs by effectively conducting interviews and leveraging various tools and analytical methods; summarize findings in a coherent manner to develop and propose appropriate solutions
Support the development of presentations and reports in support of client enablement engagements and optimization services
Maintain communication with internal and external customers to ensure customer satisfaction and continuous program improvement
Act as a liaison with field employees supporting customer training activities to provide learning and performance support
Provide program and project management related to the strategic, logistic, and tactical aspects of customer-facing and employee clinical education programs
Create and manage communications, Sharepoint portals, forums, etc
Balance a heavy workload in a fast-paced environment, while working on multiple projects simultaneously. Set individual priorities in context with team priorities, to meet goals in the face of multiple demands
Be agile and flex with business strategy changes
Act as a key contributor in a complex environment
Education: Bachelor’s degree in Education, Clinical (Pharmacy, Nursing) or healthcare related field preferred
Clinical nursing or pharmacy experience with Pyxis Technologies dispensing products required
Clinical training, experience with performance consulting and developing clinical training programs, educational materials, documentation, manuals, and online tools desired
Ability to engage C-Suite level individuals
Presentation skills required
Industry experience with Medical Devices, HIT, product implementation and support in a global environment preferred. Knowledge of health care and delivery system operations, health care informatics, and healthcare terminology (e.g., care management). Understanding of operations in the Health Care industry and a strong acumen of business processes, including operations, delivery models and revenue models
Understanding of program evaluation life cycle, data analysis, and clinical best practices preferred
Good project management experience and effective organizational skills
Confident and results-driven; consultative orientation, strong people and process/project management capability
Ability to develop and deliver learning to a wide range of audiences and cultures
Ability to independently develop complex interventions and performance support solutions
Knowledge of training methodologies, adult learning requirements, needs assessment and evaluation
Outstanding communicator; an individual who possesses superior written/verbal communication skills, as well as the ability to present his/her views in a clear and compelling manner
Attention to detail while multi-tasking several complex deliverables across multiple groups, cultures and time zones
Adaptability; learns quickly and responds positively to complexity
Comfortable working in a changing environment
Team player with superior people skills
Willing to make the tough decisions and be held accountable
Ability to travel up to 30-40% of the time

220

Clinical Territory Manager Resume Examples & Samples

3-5 years of clinical sales experience in the healthcare industry
Comprehensive clinical and technical knowledge including clinical papers. Asks skillful questions
Comprehensive knowledge of account planning, territory management and forecasting
Adoption of consultative selling strategies: excellence in planning, execution and evaluation of sales calls
Advanced negotiation skills: works to facilitate negotiations which involve other businesses (CVG)
Strong clinical and business relationships with customers
Advanced understanding of internal workings of hospital labs/ theatres / departments e.g. purchasing, consignment, clinics, patient & implant scheduling and key influencers
Computer literacy including sound knowledge of the MS Office suite of software
Proven evidence of Medtronic Traits
Bachelor degree/Tertiary qualifications in nursing, general science, business degree or similar. Post Grad qualifications highly regarded
IBRHE industry qualification
Coronary Care / ICU Catheter Lab experience highly regarded

221

Clinical Technical Service Specialist Resume Examples & Samples

Bachelor’s degree OR 4+ years’ experience in a health related field
Technical certification program in a health related field (RN, RT, biomed, ect.)
2+ years of experience Biomedical or Clinical Engineer, certified electronics or certified medical field
2+ years of call center experience within the medical or pharmaceutical industry providing clinical and technical support to customers
4+ years of experience repairing, maintaining or operating medical equipment in the medical or pharmaceutical industry – Biomedical or Clinical Engineer
Proficient experience with Microsoft Word and Excel, (Pivot Tables, V-Lookups, Macros)
Ability to trouble shoot with customers while simultaneously data entering the information directly into the computer
Demonstrated ability to work in a team environment
Possesses computer skills with experience in Word and Excel
Ability to communicate effectively via verbal and written forms

222

Clinical Product Specialist Resume Examples & Samples

Experience in patient monitoring in a variety of care settings
OR experience highly preferred
Must be goal-directed, and results oriented, with internal motivation to achieve high-level results
Strong verbal and written communication; exceptional client interaction skills
Strong ability to create and deliver presentations, education plans, and evaluation plans that reflect the needs of the customer
Exceptional thoroughness, attention to detail, and follow-through
Understanding of the markets in which Respiratory & Monitoring Solutions competes
High energy, entrepreneurial, and self-motivated
In depth understanding of consumable adoption process
Experience developing educational tools
Proficient in MS Office, including Word, PowerPoint, and Excel

223

Clinical Outcome Specialist Resume Examples & Samples

Responsible for optimizing post-surgical outcomes through education and training of physicians, technicians, and surgical staff
Assisting surgeons and staff with IOL power verification
At least five years of experience as an Ophthalmic Technician, Optometrist, or Ophthalmologist with an emphasis in the area of cataract evaluation and surgery
At least three years of experience in an ophthalmic industry setting with an emphasis on clinical work related to cataract and/or corneal refractive surgery
Must be willing to travel 50% within territory to include some weekends

224

Clinical Accounts Manager Resume Examples & Samples

Collects, analyzes, interprets, displays and reports data of employer groups utilization experience
Functions as clinical liaison to sales team, consultants and employers, acts as a liaison to RFP unit
Develops and implements work plans for selected clinical account management employer groups
Creates presentations regarding employer utilization with recommendations to control or improve
Works with other stakeholders in program planning, implementation and monitoring of program or initiative outcomes
Leads and manages multiple complex initiatives that impact the utilization, quality or effectiveness of health care delivery and/or health care services provided to members
Provides an assessment of programs, initiatives and interventions to determine the effectiveness of activities and makes recommendations to improve outcomes
Develops and leads targeted activities to improve HEDIS, CAHPS, provider satisfaction and other identified performance measures
Completes project-related communication and other communications, including member/physician mailings, business plans, graphics, minutes and agendas
Monitors and analyzes outcomes to ensure goals, objectives, outcomes, accreditation and regulatory requirements are met
Participates in departmental evaluation, audit and improvement activities
Leads, facilitates or participates in relevant committees and work groups; makes presentations; prepares reports, data or other materials for presentation
Identifies areas of improvement within the company and works collaboratively with other departments to develop clinical and non-clinical performance improvement projects
Researches best practices, national and regional benchmarks, and industry standards
In collaboration with Disease Management and Care Management, monitors the effectiveness of the programs on health outcomes. Assesses and participates in the evaluation and revision of Care Management programs to optimize health outcomes
In collaboration with executive management, identifies areas of opportunity and/or provider education
Communicates with providers, members and community resources as necessary to support the planning, implementation and evaluation of initiatives
Performs audit activities as required, participates in establishment of corrective action as necessary
Active and valid and unrestricted Registered Nurse License for applicable State preferred
Three to five years managed care, UM and/or case management experience
Experience in compliance, accreditation, service or quality improvement
Complex project management experience
OR Any combination of academic education, professional training or work experience, which demonstrates the ability to perform the duties of the position
Ability to work in an innovative health care delivery system and a belief in the HMO philosophy of delivering managed health care is desirable
Demonstrates a high level of interpersonal, negotiating, and written communication skills
Ability to independently problem-solve and interact professionally with members, providers, and staff is necessary
Basic PC skills, preferably in a Windows environment, are necessary
Knowledge of CPT coding and ICD coding is required

225

Clinical Trials Document Control Resume Examples & Samples

AA/AS degree with courses in the scientific/regulatory field or equivalent related experience
Moderate experience in a clinical and/or medical environment that includes working with regulatory records
Strong knowledge of all applicable regulations and guidelines with respect to regulatory documents and familiarity with medical terminology
Strong verbal, written, and organizational skills with a team-oriented approach
Proficiency in Microsoft Office Suite and email

226

Clinical Trial Operations Principal Resume Examples & Samples

Accountable for execution and on-time delivery of planned DSS milestones for clinical technologies from start-up through close-out
Drive DSS study team operations and connect with cross-functional study teams to deliver trials and programs
Develop and sustain strong relationships between internal stakeholders, external vendors, cross-functional peers, and DSS senior management
Synchronize deliverables between DSS, offshore resources, and vendors to deliver outcomes as planned
Influential in setting the strategy for Data Sciences (DS)
Management of operations through metrics. Categories include, but are not limited to, data, systems, general operations, and milestones
Reports into the DS Therapeutic Area leader and has accountability for global study planning and execution
Responsible for program/compound-level timelines, while ensuring compliance and quality
Responsible for the oversight of risk mitigation/risk management and contingency plans at a program level for all DSS deliverables
Influence and participate in clinical strategy team; including but not limited to protocol development and clinical technologies
Set expectations with the DSS team, the clinical study team, DS vendors, TA, and other external teams regarding timelines, processes and general coordination of the program
Communicate with confidence and leadership with these groups for prioritizations, actions, and resolutions throughout the life of a program
Act as a point of escalation for internal and external issues
Lead clinical study team in the development of key clinical trial systems, study conduct and study close-out as related to DSS operational activities
Oversee all Data Sciences timelines and metrics for assigned clinical trials
Lead DSS-related cross-functional meetings with clinical teams, safety teams and physicians
Oversee all vendor contracts for assigned clinical trials including accountability for Statement of Work (SoW) and Change in Scope
Participate in DSS-related cross-functional meetings with stakeholders as appropriate
Ensure stakeholder confidence in the health of the study by leading meetings to effectively communicate expectations, progress, issues and resolution
Partner with Total Quality Management Lead to ensure highest quality of team deliverables
Participate in any FDA or other regulatory meetings regarding assigned clinical trials
Influence decisions and approaches through effective negotiation
Ensure quality assurance as a measure to achieve audit and database lock readiness for assigned clinical trials and programs
Accountable for any audit findings regarding process execution or data integrity for any assigned clinical trial
Mentor team members
Accountable for supporting and utilizing Data Sciences policies and procedures

227

Clinical Trial Coordinator Resume Examples & Samples

Works directly with internal clinical lead and internal and external medical experts to optimize and implement clinical studies
Leads interaction and maintains strong oversight of CROs in all aspects of study implementation and any study changes
Joint responsibility with clinical lead for monitoring the implementation and progress of a clinical study
Develops and maintains relationships with external vendors
Collaborates with consultants and contractors to Research and Development
Supports the development and implementation of standard operating procedures and common work practices within the team
Clinical study team member: works closely with the Study Manager and Clinical Project Manager and is responsible for coordination, tracking, and management of logistics in support of clinical trials
Reviews clinical trial documentation including monitoring visit reports, monitoring plans, communication plans, timelines, etc
Responsible for set‐up, maintenance, reconciliation, and archiving of electronic and paper Trial Master Files along with internal working file
Coordinates TMF transfer with CROs
Interacts with CROs, vendors, investigators, monitors and other external partners to provide information and resolution for specific study requests and issues
Requires a BA/BS preferably in nursing, biology, biochemistry, or related areas. 1- 2 years of experience in clinical research operations preferred
Experience in running one or more clinical studies in the following therapy areas is desirable: anemia, chronic kidney disease, dialysis, and/or oncology
Ensures adherence to standard operating procedures, good clinical practice, and FDA regulations with strong understanding of inspection readiness
Fluent in Good Clinical Practice (GCP) and is able insure implementation within any clinical study
Excellent oral and written communication and presentation skills

228

Molecular Clinical Laboratory Scientists Resume Examples & Samples

Good laboratory practices
Knowledge of quality control practices and regulations
Laboratory experience with molecular biology techniques including DNA isolation, PCR, Sanger sequencing, Next Generation Sequencing is a plus

229

Clinical Solutions Specialist Resume Examples & Samples

Maintaining a strong understanding of Industry trends and applicable technology
Ability to work independently or in team setting; ability to adjust to changing priorities
3-5+ years clinical research experience and 3+ years successful pharmaceutical/CRO/medical sales experience ideal; comparable combination of education and experience may be considered
Operations experience in clinical trials preferred
Thorough knowledge of medical and pharmaceutical industry, terminology and practices
Proven ability in presenting

230

Head Clinical R&D Poultry Resume Examples & Samples

Design, conduct, monitor and support vaccine research and development trials with external and internal partners for the development of poultry vaccines. Generate data which support decision making processes and/or lead to market authorization
Work in a project team and initiate/manage sub-teams
Support project team work/due diligence processes/ maintenance projects
Ensure compliance in the area of GxP and work safety
Actively support patent filing
Support infrastructural projects
Support regulatory submissions by providing documentation/dossier for area of expertise and/or initiate provision of documentation via sub-team
Designing, conducting, monitoring, reporting and evaluating preclinical and clinical studies for vaccine development in poultry according to GxP regulations
Ensuring compliance with all relevant legal requirements within own area of responsibility (e.g. animal welfare, biosafety, GxP)

231

Clinical Monitor Local Resume Examples & Samples

Resource management
To be involved in evaluation of CRA resource for assigned trial,
Prepare investigator and site profile and decide on site selection by supervision,
Responsible for IMP import, distribution, return and destruction per local regulation and BI requirement under oversight,
Ensure all required local study documents including the patient information and informed consent documents in local language as well as local protocol amendments and all documents in the ISF, in close cooperation and with input from the TCM, CRA team and all other involved functions,
Responsible for translation and reviews of trial medication labels in cooperation with local DRA or other internal review functions,
In charge of clinical trial related equipment imported or purchased in China OPU, and relevant distribution, return,
Work with CRO manager/Purchasing on CRO/Vendor selection and provide feedback on service received
Trial oversight, management and operational activities
Ensure timely study milestone delivery,
Responsible for preparation of the enrolment plan with support if needed,
Responsible for routine tracking of the enrolment plan vs actual enrolment,
Ensure timely cleaning and delivery of trial data and documents, supports the completion of the Clinical Trial Report (provision of appendices) with support if needed,
Update systems timely and ensure the completeness and accuracy, e.g. CTMS,
Ensure patient safety during the conduct of the trial by reviewing regional/local safety information
Understand BI Cost structures, especially the trail budget; Clearly distinguish the cost allocation between BI & Vendors,
Establish and monitor local budget aspects including investigator fee with support if needed,
Prepare budget specification and offer for assigned study,
Responsible for IMC review through closing working with medical controller; Familiar with Finance budgeting cycle and take actions according to the timeline,
Periodically tracking and control the actual spending and extra budget based on the most updated milestone; Ensure study budget is well tracked and controlled within defined deviation percentage
Understand updated Finance SOPs and the impacts on daily business
Quality management
Meet mandatory compliance requirements and standards including ICH-GCP, BI SOP/guideline and regulatory requirement,
Coordinate to ensure appropriate study specific and medical/scientific training and advice delivered to local team including CRAs, CRO and site staff,
Act as CAPA leader for Trial case,
Ensure appropriate escalation of issues related to trial conduct and procedures as well as adequate support of CAPA,
Develop Risk Management Plan under guidance from line manager & timely maintenance during the whole trial process,
Conduct co-monitoring per BI SOP/Guideline request,
Closely monitoring the clinical data including patient safety data to be reported timely, correctly
Provide leadership
Provide leadership in the oversight and management of investigational sites in partnership with other key stakeholders (e.g. CRAs), including correct handling of IMP, patient data and material (e.g., biological samples) with support if needed,
Lead local team including CRO for outsourced study or CRA/CTA to manage the trial in accordance to protocol, SOP, ICH-GCP and regulatory requirement through routine meeting and timely communication including e-mail, phone call and newsletters by supervision,
Close contact with the global trial team and support of global trial activities,
To participate in communication with cross function including DRA team, CDMA team, PV team and BDM team, etc

232

Manager of Clinical Trial Associates Resume Examples & Samples

Manages interactions between the CTA team members and internal and external partners
Manages a team that is responsible for managing aspects of site development for US sites related to the conduct of clinical trials
Maintains a strong connection with counterparts across sites to ensure standardization of processes and appropriate resouce allocations
Identifies and manages training and guidance for the CTA team in a proactive manner to ensure consistent efficiencies are identified
Manages team resources to ensure proper workload distribution
Manages the performance and development individually for the Clinical Trials Associates
Collaborates with the management counterparts across BMS sites to ensure alignment on communication and business processes
Escalates issues and opportunities to mangement as appropriate for higher level action or senior management consideration
Manages recruitment activities for new hires into the Clinical Trials Associate role
Enhances team performance by facilitating new hire orientation process
Experience managing a team in a matrix environment
Experience preferred in the health care field or related industry
Good Clinical Practice & clinical research knowledge
Demonstrated mastery in the use of project management applications
Leadership of continuous improvement efforts
Experience with external partner management
Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems preferred
Experience with leading complex project initiatives
Bachelors Degree plus 3-5 years clinical research experience
1-3 years team management and/or supervisory experience
US military experience will be considered toward supervisory and industry experience requirements
1602766

233

Manager, Non-clinical Statistics Resume Examples & Samples

M. S. or Ph. D. in Statistics, Applied Mathematics, or Engineering majors with significant academic training in Statistics
Proficiency in major statistical software packages (e.g., SAS, R, MINITAB, and JMP)
A minimum of 3 years experience in pharmaceutical industry with technical knowledge in the following areas
1600144

234

Clinical Document Specialist Resume Examples & Samples

LI-CB
Maintain TMFs for assigned studies
The Specialist will have at least 6 years’ direct experience with trial master files in the biopharmaceutical or pharmaceutical industries. The Senior Specialist will have 6+ years’ direct experience
Must possess excellent organizational skills, follow-through, and great attention to detail
Must be able to follow standard operating procedures and effectively triage when deviations from procedures occur
Excellent oral and written communication skills. Must be able to communicate effectively with members of other departments and with study-site personnel (physicians, study coordinators, nurses, etc.) as needed
Must be advanced with computer applications such as Word and Excel, and possess the ability to learn other applications with appropriate training

235

Director, Modelling & Simulation / Clinical Resume Examples & Samples

Support global head of Modelling & Simulation (M&S) in acting as a mentor and coach to team members in Japan
Support global head of M&S to manage/oversee outsourced work with collaborating CROs for M&S work
Support global head on M&S in providing expert support to others within Global Clinical Pharmacology/Translational Medicine and project teams with respect to the design and analyses of population PK (/PD) studies
Contribute to the development of appropriate internal procedures to manage M&S work within EPCS and oversee SOPs/SWPs related to population M&S
Generating, compiling and oversee M&S analysis plans and reports in accordance with departmental SOPs/SWPs and regulatory guidelines
Conducting PK and PK/PD data analysis, using both non-compartmental and population approaches
Interact actively with clinical, statistics and data management functions within CCLO and PCUs
Draft and/or review Investigator Brochures, IMPDs, relevant sections of submissions documents (CTDs) and other Regulatory documents
Prepare Population PK and PK/PD related responses to requesting regulatory agencies
Represent Eisai at major scientific and medical meetings
Keep up to date on best current practices and knowledge in the fields of M&S and population PK/PD by attending training courses, conferences and reading relevant literature
5- years experience

236

Clinical Trial Mgmt-fde Resume Examples & Samples

Bachelor's Degree in a scientific or health-related field
Demonstrated ability to manage complex situations through problem-solving, critical thinking and navigating ambiguity
Prior clinical trial site-level experience

237

Clinical Trial Mgmt-fde Resume Examples & Samples

Understand TPO selection and qualification process
Review TPO bids and leverage Lilly’s external sourcing group to drive selection decisions
Create and manage work plan and budgets
Manage activities based on operations guides with strategic partners (functional sourcing relationships)
Understand the correlation between outsourced scope of work and the trial budget to evaluate and communicate the financial status
Effectively communicate and build positive relationships with sourcing partners and ensure timely resolution of issues
Monitor performance metrics with TPO to ensure quality delivery, make necessary adjustments and document TPO oversight

238

Clinical Data-fde Resume Examples & Samples

Provides single point of accountability and deliverable ownership for all aspects of clinical data management
Acts as a primary contact within the Data Sciences & Solutions organization for all data issues related to assigned trials
Applies specialized therapeutic knowledge and data management discipline knowledge to ensure database deliverables are consistent, accurate, adherent to the data strategy, and deliver the clinical, statistical, and business demands of the team
Bachelor’s degree in drug development in areas intersecting with clinical data management (e.g., clinical operations, statistics, information technology, health outcomes, etc.)

239

Clinical Data Leader Resume Examples & Samples

Provides the single point of requirements definition, strategy communication, and deliverable acceptance to the vendors executing delivery of clinical data management
Experience with one of the following
Vendor management experience
Virtual team environment experience
Familiarity with clinical data tools and technologies
Technical knowledge to develop requirements and/or study/project deliverables (i.e. SAS,Oracle, programming, analytical tools)
Experience in forms design and layout
Understanding and experience in using data standards

240

Clinical Trial Lead / Merck Serono Resume Examples & Samples

Works with substantial discretion and uses best practices and knowledge of internal or external business issues to improve products or services
Uses specialist knowledge, analytical skills, judgment and broad conceptual and practical experience to solve complex problems and to contribute to process improvements
Understands how the different teams jointly achieve the objectives of the area and uses knowledge of the organization, processes, customers and key business drivers to increase effectiveness
Drives protocol development process. Provides clinical, scientific and operational input into concept sheets and protocol (rational, objectives, design), Case Report Form, and other key protocol/program documents and activities
Leads the execution of clinical phases of assigned global programs across all phases (Phase 1-4) including post-marketing commitments and Biosimilars
Acts as a central point of contact for communication between the team and the external partners, developing mitigation and resolution strategies, and promptly responding to action items
Fluency in English (oral and written)
Position requires both domestic and international travel up to 30% of time

241

Principal Clinical Trial Lead Resume Examples & Samples

Implements, conducts or monitors on-site clinical trials
Takes responsibility for on-site operations of clinical trials, including documentation strategies, implementation of clinical trials protocols, standard operating procedures (SOPs) and case report forms (CRFs). May also help define or improve these but main emphasis will be on implementation. Conduct and be reponsible for clinical studies in one or more therapeutic areas
Leads own team of professional staff to identify and resolve technical, operational and organizational problems of medium complexity
Filters, prioritizes, analyzes and validates dynamic material from a diverse range of external and internal sources to respond to operational challenges
Applies understanding of how different areas jointly contribute to achieving objectives within the sub-function (i.e. a subset of a function, typically consisting of several areas with independent budgets) supported by good industry knowledge to achieve objectives
Be responsible for planning, coordinating, preparing and conducting as well as for the budget of clinical studies within assigned therapeutic area(s)
Steer all activities of the study-team and the contributions of further internal and external units
Acquire clinical/pre-clinical development strategies in the assigned therapeutic area in cooperation with the involved parties
Accountable to drive and monitor protocol related activities throughout the lifecycle of the project ensuring targets are met according to timelines, budget and quality expectations
As core member of the Clinical Operations Team and leader of the Clinical Trial Team, aligns clinical trial team with organizational goals and objectives of the Clinical Operations Team and/or Global Program Team
May in addition take leadership of the Clinical Operations Team
Leads multiple cross-functional trial teams through start-up activities including study/site budgets and contracts, global geographic deployment (country/site identification, feasibility, selection), and country/site protocol approvals (MOH, IRB/EC) to study conduct, analysis and reporting
Develops and leads the presentation on trial status to ICSC and other relevant committees for deviations from budget and timelines as needed, highlighting issues and risks
Qualifies operational feasibility and establishes and analyzes protocol-level budget and grants throughout the life cycle of the trial
Applies clinical and scientific knowledge to prioritize the clinical data review and cleaning
Drives oversight of CROs and vendor management at trial level according to the applicable partnership model
Acts as functional lead for process improvement initiatives
Understanding of trial feasibility elements
Understanding of regulatory requirements across countries
Requires substantial professional experience (approximately 8-10 years) in clinical research in CRO or a Pharmaceutical or Biotechnology Industry environment with at least five (5) years of them depth and/ or breadth of expertise in clinical trial management including managerial responsibility
Proven experience in all aspects of clinical trial planning and start up (including budget and resource planning), and in executing the complete range of clinical trial activities, from start up through final trial report
Proven track record of having successfully led one or more multinational trials
Solid leadership skills and influencing skills

242

Clinical Trials Monitor Resume Examples & Samples

Ensure the Sponsor-Investigator and study team adhere to current FDA regulations, applicable ICH/GCP guidelines, local policies and standard operating procedures, including DFCI CTO Monitoring standards and guidelines
Adhere to the protocols’ Data Safety Monitoring Plans; e.g. monitoring visit type, frequency, and required critical monitoring activities by utilizing monitoring tracking forms and other monitoring related tools and templates
Monitor clinical trial progress through a combination of remote data review and on site monitoring visits. Some travel will be required
Verify that trial data entered on the Case Report Form is consistent with patient clinical notes and other source documentation (source data verification)
Independently coordinate upcoming and ongoing monitoring assignments while meeting expected timelines for completion of monitoring activities and submission of written monitoring reports
Assist in the development and writing of clinical trial monitoring plans
Provide recommendations and guidance to study specific monitoring teams and assist in audit readiness and preparation
Participate in regular monitoring team group meetings
Bachelor's degree in a field relevant to research compliance and 3+ years of progressively responsible clinical trials experience with 1+ years of monitoring experience. Experience in an academic institution is preferred, especially working in collaborative efforts with upper administrators, faculty and research staff as well as research support personnel. Must have expertise in research ethics and the responsible conduct of research

243

Clinical Document Improvement Specialist Lead-north State Region Resume Examples & Samples

*This will be an office position located at Mercy Medical Center Redding with travel to St. Elizabeth Community Hospital in Red Bluff, CA and Mercy Medical Center in Mounty Shasta. Travel is required between facilities, and may be required for meetings ***
Assists CDI Manager with chart audits, quality audit and KPI audits
Assists CDI staff training and orientation
Oversees and leads workflow for CDI staff
Assist CDI manager with projects or tasks as needed
Provides expert level leadership for overall improvement in clinical documentation by providing proficient level review and assessment, and effectively articulating recommendations for improvement, and the rational for the recommendations
Performs regular rounding with unit-based physicians
Ensures effective utilization of the Midas Clinical Documentation Improvement Focus Study, documenting all verbal, written, electronic clarification activity
5+ years acute care hospital clinical RN experience OR Foreign Medical Graduate with CDI experience
A minimum of 2 years of experience in Clinical Documentation Improvement
Experience communicating & working closely with Physicians
CCDS, CCDP or CCS certification
Ability to lead projects with complex responsibilities and timelines

244

Clinical Pharmacologist Resume Examples & Samples

The position is responsible for efficient, innovative, and timely clinical PK, PK/PD, and/or population PK study design, analysis, interpretation, and reporting of clinical studies to support international regulatory submissions
Provide small and large molecule clinical pharmacology expertise/support in the preparation of regulatory submissions (e.g. IB, IND, NDA)
Performs pharmacokinetic analysis, interpretation, and reporting of data from clinical studies
Responsible for design, analysis and communication of data on clinical pharmacology studies
Develops and implements new clinical pharmacology studies that impact development programs
Effectively represents clinical pharmacology in cross-functional study-team settings
Works in close partnership with Quantitative Pharmacology, Bioanalytical Chemistry, Project Management, Clinical Research, Biostatistics and Clinical Trials Management functional areas to support clinical development programs
PharmD, PhD, with pharmacokinetic training, fellowship and/or postdoctoral experience and 2+ years of clinical pharmacology/pharmacokinetics
Strong understanding of clinical pharmacokinetic concepts is required
Training/experience in advanced pharmacokinetics, clinical pharmacology and/or pharmacy with clinical research, drug development is desirable
Understanding of drug development process to provide clinical pharmacology support for clinical development (Phase 1 to Phase 4) for investigational agents and/or marketed drugs
Hands-on experience in clinical trials management/study conduct and/or basic laboratory sciences is desirable
Must have established computer skills with detailed knowledge of PK programs and analysis software (e.g. WinNonlin), along with experience with scientific graphing and analysis software (Sigma plot, GraphPad, Instat, etc). Must have excellent written and verbal communication skills
Must have excellent interpersonal, written and verbal communication skills
Must have critical thinking skills and ability to make decisions
Demonstrate ability to work independently
Exhibit excellent written and verbal data presentation skills to enable contribution to internal/external teams, conference presentations and publications

245

Clinical Data Lead Resume Examples & Samples

To act as key point of contact for the sponsor and the study team on day to day study data issues, e CRF design, edit checks and other implemented documents
To take part in study kick off (internal and external) meeting with DMPM
To identify out of scope tasks and bring to the attention of DMPM and contract analyst
To develop an understanding of the revenue recognition and revenue forecasting process and assist the DMPM on a monthly basis
To lead the development of specifications, implementation and testing of the CRFs, edit checks and data review and oversight listings (DVS)
To lead the development of DMP and study specific procedures and assisting DMPM in development of project plan and timelines
To set up and maintain data management study files for inclusion in the Trail Master file and ensuring these are maintained in audit ready state
He/ She should possess excellent organizational and planning skills as well as a demonstrated aptitude or project management and ability to lead more than one project and prioritize accordingly
Working as a Team Lead/ Associate Data Lead
Experience of at least one of ICON preferred CDMS (Rave, Inform, Oracle Clinical, OCRDC)
Strong client relationship management skills, and the aptitude to develop this further

246

Clinical Molecular Geneticist Resume Examples & Samples

Strong understanding of genetics and genotype-phenotype relationships
Ability to analyze medical and scientific literature
Familiarity with statistical analyses
Familiarity with clinical applications of genetic information
Familiarity with professional and regulatory requirements of a clinical laboratory
Familiarity with informatics and bioinformatic approaches to analysis and management of large datasets, data mining
Familiarity in customer facing setting & excellent interpersonal skills
Excellent communication skills, professional and polished manners
Ability to effectively translate scientific concepts for a wide range of internal and external audiences
Ability to manage multiple projects and deliver in a time-sensitive manner

247

Clinical Trials Specialist Resume Examples & Samples

Works with multiple contract research organizations to communicate detailed timelines and ensure that performance expectations are met
Attends internal team and other meetings
Provides training as necessary at investigator meetings and other trial-specific meetings such as site initiation visits and monthly teleconferences
Travel 25% or more of the time

248

Senior Principal Clinical Pharmacologist Resume Examples & Samples

Responsible for supporting the line management in resourcing, recruitment, supervision, training and staff development in Clinical Pharmacology
Accountable and responsible for the Clinical Pharmacology support for the assigned projects (branded, generics, and other R&D programs)
Responsible for ensuring appropriate Clinical Pharmacology representation on drug/ dosage form development and clinical teams and provision of PK/PD expertise and leadership to a project
Provides recommendations for clinical doses and dosing algorithms (including drug interaction advice, food effects, special group dosing etc) to the Clinical and Development teams and in regulatory documentation such as labeling
Stays abreast of literature, government guidelines, internal guidance on clinical trial conduct including Good Clinical Practice and internal SOPs, regulations for specific projects to which assigned, in order to be a team resource of clinical pharmacology and therapeutics knowledge in terms of both medical background and clinical trial design
Acts as technical lead for specific development projects, particularly BA/BE, Phase I and Clinical Pharmacology centric studies
Manage and initiate external collaborations with leaders in clinical pharmacology and Key Opinion Leaders
Minimum of 10 years’ experience required, including at least 5 years relevant pharmaceutical or related industry experience in clinical pharmacology
Will consider 8 years’ experience with at least 2 years postdoctoral training in Clinical Pharmacology
Direct experience with clinical pharmacology summary documents required for NDA and MAA
Knowledge of FDA, EMA and ICH guidances and regulations applicable to Clinical Pharmacology
Comprehensive understanding of worldwide clinical regulatory requirements with working knowledge of drug development process with a proven record in drug development from IND through regulatory submission and commercialization. Prior direct interaction with regulatory agencies and advisory boards is required

249

Clinical SRM / Outsourcing Manager Resume Examples & Samples

Excellent knowledge of the clinical development and other science and technology development process and vendor management process (including best practices), along with the ability to bridge science and business, to oversee contracting of investigators and organizations supplying clinical and other science and technology related services and to develop with procurement contracting strategies
Experience developing a cross functional SRM program utilizing and developing Key Performance Metrics and Service Level Agreements
Demonstrated mastery of outsourcing/SRM including: category management skills, methodologies for measuring the value of outsourcing decisions (financial and qualitative), contract management, financial analysis, market analysis, supplier analysis,
Must have knowledge of cGCP, ICH, FDA, and other regulatory requirements
Supplier diversity and supplier relationship management
Expertise in internal stakeholder management, continuous improvement, and project management
Highly organized individual with the ability to set and manage multiple priorities to complete tasks within established and often, tight, timelines; work in a fast-paced matrix environment, interact well with all levels of the company, and work without direct supervision
Excellent interpersonal, oral and written communication skills
Strong analytical and problem solving skills with the proven ability to obtain results
Strong negotiation skills
Self-Starter
Proven business acumen
Display behaviors in accordance with Mallinckrodt Values
Strong computer skills; must be proficient in Microsoft Office (Word, Excel, PowerPoint), and SharePoint
Lean Six Sigma training/background preferred
Preferred background in financial modeling -Total Cost of Ownership(TCO) and Total Value of Ownership(TVO)
Membership in the International Association of Outsourcing Professionals (IAOP) and Certified Outsourcing Professional (COP) certification is highly desirable

250

Clinical Service Specialist Resume Examples & Samples

To teach prescribing physicians and key operators how to deliver a safe, effective and trouble-free THERAKOS® Photopheresis therapy to their patients
Troubleshoot and support via face to face activity and phone contact customers and Therakos field personnel
Transfer technical and clinical knowledge of the THERAKOS™ Photopheresis Systems to customers to ensure that they are capable of delivering safe and effective therapies to their patients
Certify trainees and manage the certificate process
Troubleshoot and support customers and Therakos field personnel (phone, email face to face meetings)
Release new software or kit modifications that require hands on training
Escalate market information, customer feedback and complaints, products performances and their use to the relevant departments
Handle the intake of customer complaints and associated activities with closing out those complaints in a timely and compliant manner
Attend local, regional and global commercial meetings
Build advocacy for existing and future Therakos products among national thought leaders of various target customers, including physicians, nurses, operators, hospital administrators and payers
Collaborate closely with Global Marketing and Scientific Affairs teams to develop product-positioning methods of communication for existing and future products and indications that will meet the needs of the current customer base and allow compliant expansion into to markets
Excellent English, German and French communication skills
Registered Nurse highly preferred
Advanced degree preferred in nursing or life science, pharmacy, medical technology, biomedical engineering or related field
Working experience in the medical device /pharma /healthcare industry such as clinical practice consultant, medical sales representative, customer technical support and clinical trainer
Knowledge or expertise in apheresis or immune mediated inflammatory diseases, haematology and oncology is a plus
Work permit and driver license for European Union

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