Manager, Clinical Operations Resume Samples

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OJ
O Jacobson
Olen
Jacobson
6418 Mireille Circles
Philadelphia
PA
+1 (555) 997 8267
6418 Mireille Circles
Philadelphia
PA
Phone
p +1 (555) 997 8267
Experience Experience
03/2015 present
San Francisco, CA
Study Manager, Clinical Operations
San Francisco, CA
Study Manager, Clinical Operations
03/2015 present
San Francisco, CA
Study Manager, Clinical Operations
03/2015 present
  • Works with CRO to develop and revise study specific plans and detailed timelines, and ensure that performance expectations are met
  • Proficient in developing trial plans including site monitoring plans, risk mitigation strategies, site selection, and clinical supplies management
  • Participates in the development, review and implementation of departmental SOPs and processes
  • Manages the study project plan, including timelines and budget
  • Organizes and manages internal team meetings, investigator meetings and other trial-specific meetings
  • Reviews site study documents (informed consent template and study tools/ worksheets),
  • Reviews site study documents (informed consent template and study tools/worksheets),
06/2008 12/2014
Boston, MA
Manager, Clinical Operations
Boston, MA
Manager, Clinical Operations
06/2008 12/2014
Boston, MA
Manager, Clinical Operations
06/2008 12/2014
  • Managing multiple CROs and vendor, leading cross functional study team members, and ensuring quality data
  • Ensure communication with team is strong, ensuring feedback is provided in real time through provision of mentoring and leadership coaching
  • Utilize a logical, methodical approach in independently solving problems, developing solutions, and making recommendations
  • Management of study staff including training
  • Develop biocompatibility testing strategies to qualify materials used according to global guidelines. Ensure compliance with regulatory guidelines
  • May act as training coordinator/ manager for training delivery
  • Ensures individual and work group/team tasks are completed according to country specific and government regulations
04/2001 03/2008
San Francisco, CA
Manager Clinical Operations
San Francisco, CA
Manager Clinical Operations
04/2001 03/2008
San Francisco, CA
Manager Clinical Operations
04/2001 03/2008
  • Use Press - Ganey scores to evaluate and improve patient satisfaction. Implements, tracks and reviews process improvement
  • Use Press-Ganey scores to evaluate and improve patient satisfaction. Implements, tracks and reviews process improvement
  • Performs other work related duties and activities as assigned or requested
  • Participate and may lead corporate or departmental quality or process improvement initiatives
  • May act as a client liaison
  • Act as a coach and mentor for lower level staff as they develop in their role. Works collaboratively with project leadership including the PM, client representatives and other functional leadership to manage project related challenges and to achieve exemplary customer service
  • Identifies and leads initiatives in the department according to quality measures and organizational goals
Education Education
Bachelor’s Degree in Life Science
Bachelor’s Degree in Life Science
Indiana University
Bachelor’s Degree in Life Science
Skills Skills
  • Moderate line management experience. Knowledgeable of Good Clinical Practices (FDA and ICH Guidelines), and other applicable regulations
  • Strong customer focus, ability to interact professionally within a client organization
  • Advanced knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
  • Knowledge of SOPs/guidelines, ICH-GCP and other applicable local and international regulations
  • Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
  • Excellent record-keeping skills; good documentation practice
  • Proficient computer and internet skills including knowledge of MS-Office products such as Excel, Word, Outlook and Windows
  • Strong written and verbal communication skills including good command of English
  • Ability to maintain excellent working relationships with a broad range of clinical study staff
  • Advanced clinical expertise and professional knowledge in assigned specialty area
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1

Associate Manager, Clinical Operations Resume Examples & Samples

  • Minimum of a Bachelor’s degree in Nursing, Pharmacy or other scientific discipline/related field is required
  • Minimum of 6 years direct experience in regulated industry within Clinical Research Operations (eg, pharmaceutical, device) is required
  • Proficiency with GCP and ICH Regulations are required
  • Experience supporting regulatory submissions is preferred
  • Experience with Vendor Management is required
  • This position is located on-site in Fort Washington, PA and may require up to 5% domestic and international travel.R&D
2

Program Manager Clinical Operations Resume Examples & Samples

  • 3-5 years recent clinical trials project management experience to include: addressing project forecasting, identifying complex changes, developing scope of work, leading and managing out of scope changes, leading negotiation conversations with sponsors independently, developing and managing project budget, and collaborating with faculty and other functional groups
  • Experience in a service organization including Clinical Research Organization or vendor
  • Clinical background also strong plus
  • Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum of seven years healthcare experience; or
  • Completion of a master's degree in Public Health, Health Administration or a related area with three years directly related clinical trials research experience; or
  • Completion of a bachelor's degree plus a minimum of five years directly related experience in clinical trials research; or
  • Completion of a bachelor's degree plus a minimum of six years closely related research experience
  • *State of North Carolina license may be required.**
3

Program Manager, Clinical Operations Resume Examples & Samples

  • Oversees or conducts formal market assessments of best practices in the health industry addressing the management and use of healthcare information and determines the business value and practicability for FEP. Conducts analyses, interprets findings, and develops recommendations and/or strategies to meet FEP and BCBSA core objectives. May lead or participate on team to take recommendation to implementation
  • Collects, analyzes, synthesizes and/or maintains complex data utilizing databases, survey instruments, information resources, or other research methodology. Advises and supports Plans on data analysis and reporting to support benefit cost, Care Coordination, and care management initiatives. Advises and supports Plans and internal business partners on data analysis and reporting in support of benefit cost and/or care management initiatives. Continues to identify and assess opportunities for process/systems improvement
  • Contributes to and executes projects and deliverables that cross many functional boundaries. Primary liaison to the Plans’ FEP healthcare analyst and multiple functional areas concerning the maintenance of benefit cost models and strategies for FEP
  • Represents department and FEP on internal and external groups, as assigned. Build/maintain excellent relationships with internal and external business partners and/or customers. Serve as a liaison or contact between FEP analytics and key customers. Serves as an ongoing conduit of information from customers to appropriate BCBSA staff
  • Bachelor’s degree in health care or related field or equivalent work experience
  • Minimum of three years of experience within a managed care or health services delivery setting, with expertise in claims, provider contracting, benefit cost containment programs and/or healthcare informatics
  • Minimum of three years’ experience in consulting on and implementing cost-effective care management programs
  • Advanced analytic skills with the ability to analyze and interpret data through complex analysis and develop innovative approaches to data analyses
  • Good project management skills for planning and executing multiple projects, involving multiple stakeholders, under tight deadlines
  • Ability to build consensus for business results in a decentralized decision-making structure, relying on excellent process management and conflict management skills
  • Advanced time and resource management skills with the ability to develop approaches that meet required objectives
  • Excellent communication (written and oral) and interpersonal skills with an ability to communicate to small and/or large audiences (both internal and external to BCBSA)
  • Experience working with large data repositories and/or relational databases, as well as, experience with data mining
  • Knowledge of SAS, SPSS, SQL, Cognos, MCSource or other analytical tools or languages
  • Demonstrated integrity in decision-making and actions
  • Strong PC skills with experience using database programs, spreadsheets, and word processing, including all components of MS Office (particularly MS Excel and MS Access)
  • Certification by the Academy for Healthcare Management (AHM) is a plus
  • Advance AHM certifications, certification by the American College of Healthcare Executives or Certified Health Consultant (CHC) certification is a plus
4

Regional Manager, Clinical Operations Resume Examples & Samples

  • Oversight of the planning, organization and direction of the activities of the clinic supervisory team at assigned clinics
  • Provides supervision, development and mentoring, evaluation and management of clinic supervisory staff
  • Monitors compliance of all clinic metrics (Customer Service, Membership, Retention, etc.)
  • Assists in the preparation, implementation and adherence to clinic budgets
  • Ensures region is well promoted and properly represented through marketing and community relations
  • Provides continual process improvement including all clinic processes and/or services
  • Coordinates and guides integration of new business ventures and programs
  • Performs all other related duties as assigned
  • Bachelor's degree in Healthcare or Business Administration or a related field (8 additional years of comparable work experience beyond the required years of experience may be substituted in lieu of a bachelor's degree)
  • 6+ years progressive experience in medical practice management
  • Some travel as needed
  • Proficiency in basic computer systems and applications
  • Ability to demonstrate independent initiative, make sound decisions using effective problem-solving techniques
  • Effective ability to develop interpersonal relationships
  • Ability to develop and present comprehensive reports
  • Ability to effectively communicate (both written and verbal) in a professional manner
  • Ability to lift up to 30 pounds
  • Ability to push or pull heavy objects using up to 50 pounds of force
  • Ability to sit for extended periods of time
  • Ability to receive and comprehend instructions verbally and / or in writing
5

Manager, Clinical Operations Resume Examples & Samples

  • Line management responsibilities including professional development, performance appraisals, and employee counseling for staff. Assigns project work and reviews workload for all direct reports. Manages staff by establishing goals that will increase knowledge and skill levels, and by delegating tasks commensurate with skill level
  • Provide expert operational oversight and guidance to support prioritization of activities, review and monitor the work performed, compliance, and development of contingency plans, among others
  • Manage the resource availability for the assigned staff/region, ensuring projects are suitably resourced and staffing needs are identified in a timely fashion, resolving potential resourcing conflicts to facilitate mutually beneficial resolutions. Assist in recruiting new staff, including participation in interview process
  • Ensures individual and work group/team tasks are completed according to country specific and government regulations
6

Study Manager, Clinical Operations Resume Examples & Samples

  • Oversees all operational aspects of assigned clinical trial(s)
  • Oversees clinical trial conduct including study start-up, enrollment, study conduct and close-out
  • Manages the study project plan, including timelines and budget
  • Relevant experience in managing CRO vendors such as IVRS, Central lab, Imaging
  • Works with CRO to develop and revise study specific plans and detailed timelines, and ensure that performance expectations are met
  • Further manages CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, project master files)
  • Proactively identifies potential study issues/risks and recommends/implements solutions
  • Participates in the selection, training and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function. Prepares metrics and updates for management, as assigned
  • Organizes and manages internal team meetings, investigator meetings and other trial-specific meetings
  • Reviews site study documents (informed consent template and study tools/worksheets),
  • Serves as a liaison and resource for investigational sites
  • Participates in study strategy development, protocol, CRF development, Clinical Study Report preparation, as appropriate
7

Manager, Clinical Operations Resume Examples & Samples

  • Ensure that staff have the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan, SOP review and mentored training experiences, as applicable
  • Manage the quality of assigned staff's clinical work through regular review and evaluation of work product
  • May act as a CRA or CTL for a defined project or to assist with milestone achievement
  • Bachelor's degree in a health care or other scientific discipline or educational equivalent;6 yrs of experience working on clinical trials with 3 years experience in a leadership capacity; or equivalent combination of education, training and experience
  • Therapeutic requirements: Cardiology and medical device experience preferred
  • Occasional travel, approximately 30% of work week
8

Manager Clinical Operations Resume Examples & Samples

  • Develops and implements pharmaceutical care programs to enhance quality, improve member service and enhance cost effectiveness
  • Provides leadership in the development and implementation of capital and operating budgets
  • Accountable for quality, service and fiscal outcomes
  • Responsible for pharmaceutical care activities including drug education, pharmacist's clinical role expansion, patient care, performance measurements, employee development, competency assessment, standards of practice, multidisciplinary team development, quality, and cost outcomes
  • Within an entire Service Area or assigned area(s) within a Service Area, responsible for compliance with Federal and State laws, regulations, standards, JCAHO, OSHA, Divisional & Departmental policies and procedures
  • Prepares and/or approves the bi-weekly payroll, and monitors personnel utilization in accordance with the operating budget or workload requirements
  • Responsible for personnel management activities (e.g. recruits, hires, trains and evaluates, and/or terminates subordinate exempt and hourly personnel)
  • Three (3) years of previous experience providing functional/ clinical direction in an in- or out-patient pharmacy required
  • Pharm. D. OR two (2) years of equivalent/relevant experience required
  • Residency in Clinical Pharmacy OR two (2) years of equivalent clinical experience required
  • Licensure as a pharmacist in California
  • Demonstrated self-initiative, innovation and the ability to collaborate with others
  • Ability to lead and manage professionals and others through influence and collaboration in single and/or multiple pharmaceutical care programs and sites; verbal and written communication skills
9

Manager, Clinical Operations Resume Examples & Samples

  • Leadership skills that include
  • Ability to lead a virtual team across locations and cultures
  • Enlist the support of team members in meeting goals
  • Ability to make decisions even in ambiguous situations to achieve project timelines and quality
  • Ability to proactively identify and solve problems by using a logical, systematic approach
  • Ability to conduct root cause analysis in business problem solving and process improvement development
  • Ability to manage multiple and varied tasks with enthusiasm, prioritize workload with attention to detail
  • Personal skills that include
  • Ability to successfully work in a team environment
  • Ability to gain trust and confidence with a client as well as within PAREXEL
  • Good consulting skills
  • Flexibility to change
  • Business / operational skills that include
  • Commitment to delivery and quality
  • Provision of win-win solutions to problems
  • Knowledge of SOPs/guidelines, ICH-GCP and other applicable local and international regulations
  • Proficient computer and internet skills including knowledge of MS-Office products such as Excel, Word, Outlook and Windows
  • People Management skills that include
  • Demonstrated ability to successfully manage a full workload across multiple-projects
  • Ability to manage and motivate direct reports
  • Excellent interpersonal, verbal and written communication skills (including experience in making presentations at conferences, meetings, training sessions)
  • Ability to work in a matrix environment and to value the importance of teamwork
  • Language skills
  • Competent in written and oral English and local language
  • Substantial experience in clinical research including relevant experience as a team Leader in Clinical functions or proven experience in coordinating clinical trials
  • Relevant Work experience in clinical research
  • Experience in Coordination of Clinical Trials – Preferably relevant working experience as an Associate Clinical Manager or proven experience in a similar role
10

Senior Manager, Clinical Operations Resume Examples & Samples

  • Undergraduate degree in clinical science or health-related field from an accredited institution, or equivalent work experience required
  • Substantial experience supervising or managing professional staff in a clinical research environment required to include past managing functional line managers
  • Extensive experience using computerized information systems required; experience with PC-Windows, word processing, and electronic spreadsheets required
  • Substantial clinical trials development experience is required
  • Thorough knowledge of ICH and local regulatory authority regulations regarding drug research and development is required
  • Previous experience in a CRO environment is preferred
  • Excellent organizational, record retention, and time management skills
  • Excellent working knowledge of ICH-GCP, applicable law (local and country) and regulatory requirements
  • Solid understanding of the drug development process with a special emphasis on clinical development
  • Ability to handle multiple tasks as well as to proactive identify and resolve complex problems and issues
  • Ability to participate in initiatives, and create and implement new processes
  • Excellent Leadership skills with ability to lead and facilitate cross-functional working groups and teams
11

Associate Manager, Clinical Operations Resume Examples & Samples

  • CRA/CMA experience or minimum substantial relevant experience (preferably on site monitoring experience)
  • “Coordinating experience”: Preferably obtained while working in a Sr. CRA or Sr. CMA position
  • Substantial experience in clinical research in Clinical functions
  • Individuals should have potential to understand cross functional activities related to data processing, cleaning and site management
12

Manager Clinical Operations Resume Examples & Samples

  • Manage overall operation of an Oncology practice and assures that required policies, systems, procedures and standards are in effect and communicated to Oncology personnel
  • Ensures all physical, educational and community support needs of the Oncology patient and family are met
  • Oversee day-to-day operation of Oncology to include scheduling of patient, physician and treatment visits
  • Monitors clinical competency of staff to ensure patient care is delivered appropriately and consistent with OptumCare’s best-practices and industry standard measures
  • Identifies and leads initiatives in the department according to quality measures and organizational goals
  • Use Press-Ganey scores to evaluate and improve patient satisfaction. Implements, tracks and reviews process improvement
  • Assists with developing unit operating and capital budgets, reviews periodic performance reports and maintains expenditures within allocated resources
  • Identifies, recommends and justifies any additional departmental needs, i.e., space requirements, equipment and staff to the Assoc. Director
  • Bachelor’s degree in public health, business or related field preferred; and / or equivalent and relevant work experience
  • Strong comprehension of HMO, PPO and capitated risk plan contracts
  • Expert level knowledge in Word, Excel, clinical information systems, electronic medical records, billing systems and other population health applications
13

Manager, Clinical Operations Resume Examples & Samples

  • Works closely within appropriate business unit/region to ensure staff performance on studies and correct deficiencies as identified by staff, clients, and auditors
  • Conducts various types of assessment visits to ensure Clinical Operations on-site performance. May develop and oversee training plans to address performance deficiencies. Ensures staff adhere to training guidelines, training records are maintained and individual and corporate training needs are identified and addressed
  • Proactively works to ensure staff retention and turnover rates remain within expected levels
  • Organizes and chairs clinical staff meetings at regular intervals. Manages issues and provides follow up for action items requiring resolution
  • Bachelors degree in Life Science or equivalent discipline
  • Moderate Clinical Monitoring experience encompassing study start-up through close-out activities required with study lead experience, along with Clinical research/field monitoring experience with multiple sponsors and/or multiple clinical/therapeutic areas preferred and ideally either didactic or field training experience
  • Moderate line management experience. Knowledgeable of Good Clinical Practices (FDA and ICH Guidelines), and other applicable regulations
  • Effective demonstrated verbal and written communication skills, as well as a strong command of the English language
  • Ability to work independently and within a team environment is required
14

Manager Clinical Operations Resume Examples & Samples

  • Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters
  • Provide a leadership role in country/region clinical resourcing process through continual evaluation of existing and future resource alternatives, pro-active planning and collaboration with study team leadership and operational peers
  • Act as a coach and mentor for lower level staff as they develop in their role. Works collaboratively with project leadership including the PM, client representatives and other functional leadership to manage project related challenges and to achieve exemplary customer service
  • Analyze and reviews budgets for clinical studies within region. Pro-actively plan for appropriate clinical operations budget consumption and guides line managers and CRSs in managing variances and in developing corrective fiscal action plans
  • Conduct Clinical Project Review and participates in Project Management Review according to regional guidelines and interfaces with appropriate functional leadership to achieve positive outcomes
  • Strong knowledge of clinical research financial parameters and project financial tracking and accounting methods
  • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
  • Strong written and verbal communication skills including good command of English
  • Bachelor's degree in a health care or other scientific discipline or educational equivalent; 12 yrs of clinical trials experience including 7 years experience in a leadership capacity; or equivalent combination of education, training and experience”
15

Manager, Clinical Operations Resume Examples & Samples

  • Manages day to day activities of all aspects of the external studies department for assigned projects including study plans, timelines, resources, problem identification and resolution, status reports and budget to ensure timely delivery of completed study reports to the project teams
  • Manages direct report Clinical Research Associates (CRAs) including recruitment, training, coaching, assignments, coordination of workload priorities and performance management
  • Manages independent consultants including CROs, clinicians, independent CRAs, or statisticians when required by the project including selection, coordination of project specific training, and payment
  • Manages the development and implementation of improved processes for execution of external studies within the Ventana Quality System
  • Management of study staff including training
  • Develops and monitors budget
  • Monitors work to ensure quality, and continuously promote Quality First Time
16

Manager, Clinical Operations Resume Examples & Samples

  • Assists in the development and implementation of CA Division Pharmacy strategies in the clinical management of pharmaceuticals
  • Assists in the planning, development and implementation of Ambulatory Care Pharmacy and Drug Education services/programs for an entire Service Area or for assigned area(s) within a Service Area
  • Provides leadership and direction to staff including hiring, evaluating and coaching
  • Develops a team of professionals who plan and implement goals and objectives
  • Administers all departmental policies and procedures
  • Ensures that AmCare and Drug Education activities integrate with Service Area and CA Division Pharmacy Services Business Plan
  • Accountable for fiscal outcomes
  • Works in collaboration with providers, department heads, Drug Education Coordinators and the Pharmacy Management Team to implement quality management programs
  • May coordinate Ambulatory Care and Drug Education programs/services within a Service Area or for an assigned area(s) within a Service Area
  • Three (3) years of management experience in an ambulatory pharmacy preferred
  • Knowledge of all facets of in- and out-patient Pharmacy operations, including clinical, professional, legal, business, and public relations
  • Ability to provide leadership and work as a member of a professional team
  • Travel within the Service Area, region and state
17

Associate / Manager, Clinical Operations Resume Examples & Samples

  • Responsible to lead and manage the project team on regional or global studies
  • Responsible for designing and overseeing the implementation of project specific procedures to ensure that the study goals are met
  • Participate in clinical operations quality or process initiatives
  • Degree in Science, with a major in Pharmacy, Biological / Life Sciences or Nursing from a recognized tertiary institution
  • At least 7 years' of experience working on clinical trials with 3 years' experience in a leadership capacity
  • Able to travel when required
18

Manager, Clinical Operations Resume Examples & Samples

  • ... Effectively coach and mentor junior team members
  • Manage projects to coordinate biological safety testing for Baxter’s product portfolio
  • Develop biocompatibility testing strategies to qualify materials used according to global guidelines. Ensure compliance with regulatory guidelines
  • Develop regulatory summaries for DHF files, 510 K submissions, and CE Mark
  • Utilize global material database for material management
  • Develop project schedules; provide estimates and timelines to meet project milestones
  • Attend Project Review and Core team meetings
  • Implement the use of ISO10993-1, regional pharmacopeia, 21 CFR Part 58 Good Laboratory Practices for Non-Clinical Laboratory Studies, and/or other regulatory guidance documents to qualify Baxter products
  • Perform biocompatibility assessments in Trackwise 8 and work with cross functional team members (engineering, extractables and leachables etc.) in order to determine a comprehensive testing strategy
  • The position requires relevant technical knowledge in biocompatibility and general understanding of material physical and chemical properties
  • Ability to understand and apply global regulatory guidelines including OECD and FDA GLP, ISO10993 series, regional compendia
  • Good oral and written communication in English
  • Experience in working in global cross-functional teams and project management desired
  • Utilize a logical, methodical approach in independently solving problems, developing solutions, and making recommendations
  • Ability to make decisions when provided with limited information
  • Contribute to efforts beyond own scope of responsibilities to ensure project milestones are met
  • Excellent attention to detail
  • Software knowledge of Siemens Teamcenter Unified, Microsoft Office, and TrackWise recommended
19

Manager, Clinical Operations Resume Examples & Samples

  • Conduct Clinical Development programs. Responsible for the identification and management of necessary resources to successfully initiate and complete clinical trials. Lead the Clinical Operations team to develop clinical strategies (and project plan) to efficiently manage the project(s) and maintain regulatory compliance. This includes but is not limited to
  • Clinical Plan - Partner with the Medical Monitor, Regulatory Affairs and Commercial to prepare a clinical plan for each project. This includes preparing timelines and budgets for the clinical program
  • Clinical Trial Protocols - Prepare directly or facilitate preparation of protocols including study design, case report forms, study procedures. Develop and complete enrollment feasibility evaluations based on protocol synopsis. Draft informed consents based on study and regulatory requirements
  • Research Agreements and Study Budgets - Prepare research agreements and negotiate study budgets with sites
  • Identify clinical investigators and assess suitability of study sites. Recognize and maintain strong business relationships with key opinion leaders
  • Plan and conduct investigators meetings
  • Order clinical supplies and ensure logistics plans are in place prior to study start
  • Train study staff on product usage, data collection and specific procedures
  • 5 years (or more) pharmaceutical or device clinical development experience
  • Significant experience managing in-patient studies
  • Comprehensive understanding of the drug/device development process
  • Solid technical basis in pharmaceutical development and delivery systems technologies
  • Proven ability in planning and conducting clinical trials
  • Protocol, Report and Investigator’s Brochure writing experience
  • Experience with regulatory submission procedures, e.g. NDA, CTD
  • Experience in project management practices
20

Associate Manager, Clinical Operations Resume Examples & Samples

  • Bachelors or equivalent degree, health related preferred
  • Clinical site monitoring experience, preferably having monitored and/or managed a study within a country
  • Cxperience in functional budget planning, resource planning & assignment, quality management in a country lead capacity preferred
  • Experience in line management of staff including performance management, growth and development, managing employee relations, coaching and mentoring of staff and teams preferred
  • Excellent interpersonal skills with the ability to communicate persuasively and with clarity, flexibility and adaptability to changing requirements, resourcefulness and creativity
  • Demonstrates business ethics and integrity
  • Demonstrates proactive and positive team player
  • Exhibits strong planning and organizational skills and high level of flexibility in a dynamic environment with competing projects and deadlines
21

Senior Manager Clinical Operations / COM Resume Examples & Samples

  • Minimum of eight (8) years relevant clinical research experience in a
  • Thorough knowledge of drug development process, relevant SOPs, ICH, and GCP guidelines
  • Minimum of five (5) years as a Line Manager required
  • In-depth knowledge of Oncology, Cardiac or Neuroscience study conduct and study oversight
22

Manager, Clinical Operations Resume Examples & Samples

  • 3 years SQL or SAS experience
  • 5 years claims analysis experience
  • 5 years of experience working in a matrixed healthcare organization, preferably in the payer space
  • Ability to thrive independently and in a fast-paced environment
  • Graduate degree in Economics, Statistics, Business Administration or a related discipline
  • 3 years HL7 experience
  • 3 years clinical tool implementation experience
  • 3 years of experience managing teams, preferably in a remote setting
  • 5 years Clinical Data Acquisition or EMR Implementation Experience
23

Manager, Clinical Operations Resume Examples & Samples

  • Managing multiple CROs and vendor, leading cross functional study team members, and ensuring quality data
  • Employing knowledge of regulatory requirements, GCP, and clinical drug development
  • Effectively communicating with internal teams, sites, and vendors
  • Bachelor’s Degree; RN, BSN, or scientific degree preferred
  • Previous experience as a Clinical Trial Manager, Clinical Study Manager, or Clinical Research Manager, etc
  • At least four years of CRO and vendor management experience
24

Manager, Clinical Operations Resume Examples & Samples

  • Manage staff in accordance with organization's policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters
  • Participate in the allocation of resources to clinical research projects by assigning staff to clinical managers that are appropriate to their experience and training
  • May act as training coordinator/ manager for training delivery
  • May participate in clinical operations quality or process initiatives. Perform other duties as Line Manager assigned
25

Manager, Clinical Operations Resume Examples & Samples

  • Strategically partner to develop and deliver clinical studies globally for both internal and external stakeholders to optimize product life-cycle, with flawless execution
  • Bachelor or Masters in Science or Healthcare discipline
  • At least 7 years related experience in (conducting) clinical studies (healthcare setting , CRO, medical device and/or pharmaceutical company and/or industry)
  • A pro-active, committed and motivated attitude
  • A demonstrated working knowledge of GCP, ICH guidelines, ISO Standards, FDA/EU regulations
  • Ability to work very accurate and thorough
  • Excellent record-keeping skills; good documentation practice
  • Ability to maintain excellent working relationships with a broad range of clinical study staff
  • Ability to work well in a team environment but also independently without significant oversight
  • Ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines
  • Flexibility in work hours and readiness to travel
26

Manager, Clinical Operations Resume Examples & Samples

  • Demonstrates complete understanding of Central Sterile Processing Management (CSPM) and Surgical Endoscopy Solutions (SES) processes and the ability to manage, train and implement in a contracted facility
  • Develops and enforces the implementation of policies, new processes, procedures, product conversions, new services and programs in conjunction with the contract and IMS to improve client service
  • Implements an efficient means of communicating with contracted facility, IMS employees, and IMS management to ensure quality. Conducts regularly scheduled meetings with contracted facility management to provide timely updates of project objectives and resolve any barriers. Conducts meetings with IMS employees on a regular basis to communicate timely updates of project objectives and resolve any barriers
  • Interviews, hires, assists with training, coaches and disciplines employees to meet company objectives and customer requirements. Direct manages personnel of contracted facility if outsourced
  • Provides weekly updates to DSPW and submits to IMS Corporate in a timely manner
  • Reviews/updates the implementation plan weekly to ensure target dates are met and barriers identified
  • Abides by all company and contracted facility safety and health policies, and procedures
  • Maintains professional relationships with all contracted facilities departments, as necessary and within contractual guidelines, to ensure effective, efficient support to the patient caregivers as it relates to the scope of the contract
  • Demonstrates comprehensive understanding of the facility contract and the project implementation plan
  • Educates and assists in training of client facility management staff in all aspects of contracted services. Conducts facility employee assessment to develop baseline knowledge level to identify opportunities for education/training to improve SPD processes
  • Manages contracted facilities within budget as specified in facility contract and initial costing performance statements; maintain systems for the preservation of IMS and client facility resources such as surgical instrumentation
  • Resolves client issues in a timely and efficient manner
  • Submits and tracks contracted facility productivity and statistical reports to IMS and client as necessary
  • Ensures proper operational processes are followed by all members of the IMS team in conjunction with the Department of Health JCAHO, OSHA, CDC, AAMI, AORN standards and facilities goals and policies
  • Ensures accuracy and completeness of all administrative documents and functions (time records, count sheets, inventories, billing, etc.) required by the contracted facility and IMS corporate
  • Ensures proper training of IMS employees. Ensures that monthly in-service programs are being conducted and documented
  • Ensures proper IMS coverage at the facility
  • Provides supervision and coordination of SPD team including coordinators and technicians at the assigned facilities. May supervise facility staff if contract calls for outsourcing
  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
  • Bachelor's degree (B. A.) from four-year college or university preferred; or one to two years related experience and/or training; or equivalent combination of education and experience. Previous experience as an SPD Manager/Supervisor preferred
  • Requires thorough working knowledge of Microsoft Office applications
  • Extensive medical instrument/ equipment knowledge preferred
  • Ability to work in a high stress, constantly changing environment. If assigned to travel, must maintain valid driver’s license, current vehicle insurance and valid credit card
  • Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
  • While performing the duties of this Job, the employee is regularly required to use hands, sit and talk, see and hear. The employee is occasionally required to stand and walk. The employee must frequently lift and/or move up to 40 pounds and push/pull in excess of 100 pounds
  • Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
  • While performing the duties of this Job, the employee is occasionally exposed to fumes or airborne particles and toxic or caustic chemicals. The noise level in the work environment is usually quiet
27

Associate Manager, Clinical Operations Resume Examples & Samples

  • Supports in the inhouse organization, management and execution of projects to ensure the clinical trials are conducted, recorded, and reported in accordance with the protocol, federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research
  • Participates in the study startup activities and site opening activities as well as study conduct and site closure tasks
  • Manages the activities of clinical investigative sites across multiple protocols and multiple therapeutic areas, with appropriate supervision.Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and followup
  • One year of clinically related experience in a medical profession, pharmaceutical, or diagnostic company is preferred. Current knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials is preferred
  • Knowledge of conducting industry sponsored clinical research (e.g. Clinical study coordinator/ data manager, clinical trial assistant (or equivalent), regulatory document specialist) is preferred. Knowledge related to ICH/GCP Guidelines and applicable local regulations is preferred
  • Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic
  • Strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity. Ability to address study related clinical site issues with appropriate guidance and initiates and communicate corrective action as indicated. Ability to use functional expertise and exercise good judgment
  • Demonstrated business ethics and integrity
28

Senior Manager, Clinical Operations Lead Resume Examples & Samples

  • Develop scientifically robust, operationally feasible and clear protocol concepts and protocols, and feasible protocols and robust data monitoring plans
  • Leverage appropriate on going data review to identify and mitigate patient safety, study design, data integrity or study conduct issues
  • Secures operational excellence and delivery for one or more clinical studies by
  • Developing operational strategy (including ancillary vendors) aligned with the program strategy and incorporating country input through the study Clinical Country Lead
  • May also be responsible for contributing to a clinical development plan within a program moving into a new or subdivision of a current indication
  • Builds a rich knowledge of specific Area(s) of Expertise within a phase
  • Utilizes operational expertise and scientific assessment to evaluate study feasibility: assess end point measurement options, and ensure the successful execution of study(ies)
29

Senior Associate Manager, Clinical Operations Resume Examples & Samples

  • Site Monitoring Experience: Minimum 3 years plus at least 1 year of direct line management experience preferred
  • Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and to drive smart decision making
  • Exhibits strong planning and organizational skills and high level of flexibility in a dynamic environment with experience leading (within country or region) projects with competing deadlines; Experience across multiple Therapeutic Areas and Study Phases
  • Demonstrates/Drives continuous improvement and simplicity in process and approach and enhances agility
30

Senior Manager, Clinical Operations Lead Resume Examples & Samples

  • Good general knowledge of clinical development with a good understanding of the early clinical development phase including its objectives and specificities
  • Interested in science and able to scientifically understand protocols
  • Ability to establish study operational plans and to ensure their execution by leading the cross-functional team and overseeing the CROs and vendors. Requires a balance of scientific and operational/project management and team leadership expertise. Must be able to build effective relationships across and up and down the organization
  • Ability to adapt to different operating models and to quickly shift strategy based on new information
  • Ability to leverage rapid turnover of studies
  • Ability to operationalize studies with new indications or patient populations, novel endpoints and new procedures
  • Able to partner with other functions and both internal and external stakeholders
  • Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development
31

Business Change Manager, Clinical Operations Resume Examples & Samples

  • Requires a BA/BS degree in a related field; 5-8 years of process or project related experience that includes experience in successfully developing and managing projects with fairly significant operating budget and knowledge of process redesign; or any combination of education and experience, which would provide an equivalent background
  • You must be competent in MS Office suite to include Word, Outlook and Excel
  • Direct working experience in health or managed care
  • Direct working experience in leading Clinical Operations specifically Project Management, Product Development or Project Implementation designed based on state authorizations
  • Direct working knowledge of clinical model – functional or operational
  • Knowledge of Medicaid, managed care and/or Medicare Experience working with new product launches
32

Manager, Clinical Operations Resume Examples & Samples

  • Act as main contact for all CLO study activities and represent CLO on Study Team and associated sub-teams
  • Ensure CLO responsibilities for any cross-functional deliverables are met throughout the study, including study close-out and delivery of CLO related appendices for finalization of CSR
  • BA/BS or higher in nursing, life or health sciences is preferred
  • 6 + years of pharmaceutical /biotech industry experience
  • 4 + years of experience in clinical research
  • Some line management experience (1-2 years) is preferred
33

Associate Manager, Clinical Operations Resume Examples & Samples

  • Participate in the selection and onboarding process for new CTAs/CRAs/CRSs by conducting candidate review and participating in the interviewing process. Conduct onboarding training for new staff in conjunction with Human Resources and Learning and Development training programs
  • Ensures that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by clinical operations management
  • May fill in as a CRA for a defined project or to assist with milestone achievement on a temporary basis
  • All responsibilities are essential to job functions unless noted as non-essential (N)
  • In-depth knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients
34

Senior Manager, Clinical Operations Resume Examples & Samples

  • 8 years of pharmaceutical industry experience
  • 6 years of experience in clinical research
  • Previous experience working in global environment
  • History of successfully developing effective relationships with outside vendors and CROs
  • Outstanding verbal communication skills which resulted in professionally communicating and guiding individual and team efforts related to Clinical Operations
  • Demonstrated skills in negotiation, multi-tasking, organization and decision making
  • Proficiency in databases, coding and data mining methodologies we well as Microsoft applications
  • Ability to travel to global sites required
  • Prior experience working on cross-functional teams in a lead capacity
35

Manager, Clinical Operations Resume Examples & Samples

  • Develop, manage and train Clinical Affairs teams on comprehensive processes and workflows to ensure investigational device accountability and payments are in accordance with regulatory and company requirements
  • Ensure timely and accurate investigational device inventory to include management of par levels, expiration dates, shipment initiation and returns according to regulatory and company guidelines
  • Collaborate with cross functional global partners to forecast investigational device inventory plans
  • Manage clinical trial payments and related processes
  • Develop and maintain detailed metrics reporting
  • Manage, develop and train direct reports with various levels of experience
  • Develop and manage budgets
  • Maintain regular contact and collaborate with partner TMTT clinical teams, consultants, customers and network appropriately with relevant stakeholders
  • Must be able to travel 10- 25%
  • A bachelor's degree and a minimum of 6 years of related experience is required. An advanced degree in a related discipline is preferred
  • Meticulous organizational skills and the ability to meet tight deadlines in an environment of competing priorities
  • Proven ability to develop strong relationships with both internal and external customers. Ability to influence change
  • Demonstrated strong problem-solving, process improvement, analytical, and collaborative skills
  • Proven ability to organize, analyze, and present data and relate findings to business solutions
  • Experience in creating and managing complex budgets and spreadsheets
  • Comprehensive written and verbal communication, facilitation, presentation and follow-up skills
  • Requires a broad cross-disciplinary and in-depth knowledge of the clinical profession
  • Ability to effectively lead and manage a diverse team with experience supervising or mentoring subordinates
  • Detailed project management experience
  • Experience in clinical and regulatory aspects of medical device technology
  • Relevant clinical trial experience in heart valve disease, coronary artery disease, peripheral vascular disease and congestive heart failure areas preferred
  • Advanced knowledge of international regulations of Good Clinical Practice (GCP) and experience with Class II & III medical devices preferred
  • Computer skills – CTMS and Microsoft Word and Access. Advanced Microsoft Excel and PowerPoint skills are required
36

RTS Manager, Clinical Operations Resume Examples & Samples

  • Manage the start-up & ongoing activities, for US Clinical Operations within Call Center
  • Day-to-Day line manager responsibility for the LPN Clinical Specialist
  • Develop and maintain the clinical procedures to support operational activities
  • Responsible for training and compliance within the RTS Call Center including training record management
  • Responsible for the QAPI process both in call center and within the RTS US Legal Entity
  • Quality Monitoring – developing a sustainable and effective program for QA within the Call Center
  • Working with the Operational Director on strategic clinical initiatives
  • QMS IT Platform – Responsible for day-to-day system administration of the tool
  • Close liaison with the RTS Medical Director and the RTS Chief Medical Officer to ensure compliance to protocols and procedures/playbooks
  • Qualified RN
  • Good interpersonal skills; good negotiation and influencing skills desired
  • Experience in leading a team
  • Minimum of 5 years’ experience
37

Manager, Clinical Operations Resume Examples & Samples

  • Bachelor's degree in Nursing (BSN). A Master's degree in Nursing (MSN) may be substituted provided the incumbent also possesses a Bachelor's degree in another field
  • Minimum of two years of nursing experience
  • Current Washington State RN license
  • National certification in a clinical specialty area must be obtained within three years of employment
  • Current BLS for Healthcare Providers
  • Advanced clinical expertise and professional knowledge in assigned specialty area
  • Working knowledge of computer systems/applications, and proficiency using Microsoft Outlook, Word, Excel
  • Strong developmental and organizational skills
  • Strong leadership skills, including competences in performance management, problem resolution, project management, quality improvement techniques, training, coaching, and mentoring
  • Strong verbal and written communication/interpersonal skills
  • Advanced analytical, problem-solving and critical thinking skills
  • Able to establish and maintain productive work relationships with all levels of the organization and with patients/ clients/vendors
  • Able to maintain a culturally sensitive perspective
  • Able to effectively manage and develop staff to meet the changing needs of the organization
38

Manager, Clinical Operations Resume Examples & Samples

  • 6 + years of clinical research experience
  • 4 + years of experience in pharmaceutical /biotech industry experience (preferrably in study lead capacity)
  • Some line management experience (2+ years) is preferred
39

Manager, Clinical Operations Resume Examples & Samples

  • Supervise assigned clinical staff. This includes
  • Demonstrate leadership qualities
  • Work positively as a team
  • Maintain strict confidentiality with regard to patient and staff information
  • Maintain and promote professionalism in all interactions
  • Demonstrate decision-making skills and be proactive
  • Accept feedback in a constructive fashion and work to improve performance based on feedback
  • Demonstrate accurate information gathering and documentation skills
  • Use verbal and written means of communication responsibly and in a clear and concise manner
  • Use varied means, including continuing education, to expand knowledge base of pediatric surgical subspecialties