Clinical Research Manager Resume Samples

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JS
J Schaefer
Jennie
Schaefer
408 Kiel Summit
Philadelphia
PA
+1 (555) 796 3447
408 Kiel Summit
Philadelphia
PA
Phone
p +1 (555) 796 3447
Experience Experience
Dallas, TX
Asst Clinical Research Manager
Dallas, TX
Crona-Eichmann
Dallas, TX
Asst Clinical Research Manager
  • Identifies operational, logistical, and regulatory challenges related to the conduct of clinical trials and acts as a leader in overseeing their resolution
  • Collaborates with the DFCI QACT to develop study forms, database information, and to establish guidelines for monitoring data quality control
  • Assists the principal investigator in developing the protocol budget, in collaboration with Research Administration and the Grants and Contracts offices. Work with grant managers and other financial managers in the reporting and accounting of these funds
  • Responsible for the recruitment and oversight of coordinator staff as well as ensures that staff has completed mandatory training in a timely manner. Develops and oversees a program specific on-boarding and orientation process and participates in annual performance evaluations and competency assessments of research staff
  • Provides in-service training and serves as a resource to other clinical personnel including physicians, nurses, pharmacists and other allied health professionals regarding clinical trials, protocols, GCP guidelines, federal regulations and site SOPs
  • Assists the principal investigator in preparing manuscripts for publication
  • Oversees registration of protocol patients with QACT, study group registrar and pharmaceutical company as outlined in protocol
New York, NY
Clinical Research Manager
New York, NY
Watsica Group
New York, NY
Clinical Research Manager
  • Conducts site assessments visits to ensure research sites are implementing the study per protocol and to provide guidance for operational management
  • Develops and maintains a network of clinical and scientific contacts
  • Develop and lead the personal and professional development programs of clinical team personnel
  • Develop or contribute to protocol development as necessary
  • Conduct quarterly performance reviews and continuous employee development
  • Provide a leadership role in developing, implementing and evaluating the conduct of studies
  • Proactively engages senior clinical management in program risk discussions and provides well thought out solutions to issues
present
Dallas, TX
Oncology Clinical Research Manager
Dallas, TX
McLaughlin, Douglas and Price
present
Dallas, TX
Oncology Clinical Research Manager
present
  • Working with regulatory issues and the broader organization
  • Performance or compliance issues
  • The CRM is responsible for quality and compliance for assigned protocols in the country and oversees CRAs and/ or CTCs and training compliance
  • The CRM is responsible for clinical trial education to sites, and acts as the country POC for programmatically outsourced trials for assigned protocols
  • Examples of common problems include
  • The CRM is responsible for collaboration and relationship management with investigators for insourced and outsourced studies, with functional outsourcing vendors and other external partners
  • The CRM oversees country and site validations, site selection and recruitment in assigned protocols
Education Education
Bachelor’s Degree in Related Field
Bachelor’s Degree in Related Field
University of Southern California
Bachelor’s Degree in Related Field
Skills Skills
  • 2+ years of Clinical Research experience
  • Experience with Word, submission activities and Annual Reports
  • Great interpersonal skills
  • Excellent communication skills (written and verbal)
  • Strong attention to detail
  • Highly organized
  • Able to multitask efficiently and effectively
  • Experience with Documentum and eCTD software
  • Position Title:Clinical Research Manager
  • Sector :Janssen
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15 Clinical Research Manager resume templates

1

Clinical Research Manager Resume Examples & Samples

  • 2+ years of Clinical Research experience
  • Bachelor's Degree in a related field
  • Experience with Word, submission activities and Annual Reports
  • Able to multitask efficiently and effectively
  • Experience with Documentum and eCTD software
2

Clinical Research Manager Resume Examples & Samples

  • A minimum of 5 or more years clinical monitoring and clinical operations experience within a pharmaceutical, biotechnology, or contract research organization is required
  • Experience of early clinical development, particularly with antiviral or anti-infectious disease compounds is preferred
  • Significant experience of Service Provider selection and management is required
  • In depth knowledge of the Code of Federal Regulations related to clinical research, ICH GCP guideline and other applicable regulations and practices is required
  • Ability to prioritize and handle multiple tasks and to facilitate and resolve cross-functional activities and issues required.Clinical Trial Administration
3

Clinical Research Manager Resume Examples & Samples

  • A Bachelor’s degree with a minimum of 10 years clinical research experience (this can be a combination of industry/academic related experience). OR a PhD or equivalent degree in Biological Science or related discipline with a minimum of 8 years related scientific / technical experience, including leadership / management role within Clinical Research
  • A minimum of 1-2 years of people management related experience is required for this role
  • Experience in the Code of Federal Regulations (CFR) for conducting clinical research trials is required
  • Orthopaedic (Spine) device experience is preferred
  • Investigational Device Exemption (IDE) experience is strongly preferred
  • Ability to provide strategic and scientific clinical research input across projects, including complex and / or transformational projects with a proven track record in delivering clinical programs within clinical / surgical research setting, on time, within budget and in compliance to SOPs and regulations is required
  • Comprehensive understanding of clinical trial regulations across multiple regions is preferred
  • Ability to lead teams to deliver critical milestones, including complex projects is required
  • Ability to collaborate across different functional areas within Clinical Research to ensure alignment with governance processes (assigning roles and responsibilities, setting priorities, managing deliverables, etc.) to meet business objectives is required
  • Demonstrated ability to build collaborative relationships with key internal and external partners and stakeholders is required
  • This role will be located in Raynham, MA and will require up to 30% domestic and international travel
  • Connect - foster strategic partnerships with key internal & external stakeholders to ensure development and timely delivery of innovative EGS / EDS
  • Shape – build strong relationships with external stakeholders to shape and influence relevant policies
  • Lead – develop talent to provide strategic and scientific clinical research capability, including responsibility for professional development of direct reports
  • Deliver – ensure clinical programs are delivered on time, within budget and in compliance to regulations and SOPsClinical Research non-MD
4

Clinical Research Manager Resume Examples & Samples

  • Position Title:Clinical Research Manager
  • Sector :Janssen
  • Location: Taipei, Taiwan
  • Evaluates and projects resource needs for assigned portfolio, and liaises with local TCSM management for resource requests as appropriate
  • Strong interaction with Flex Resource managers to provide feedback on Flex Resource performance. Works with Flex Resource managers to on-board and off-board staff
  • Interviews, hires, develops and trains staff
  • For employees: Responsible for performance and development in accordance with the Performance Management guidelines, including talent development, coaching, mentoring and providing ongoing performance assessment
  • Ensures staff have a clear understanding and knowledge of GCO SOPs, Work Instructions and Company Policies supported by documentation of training compliance in Learning @ Pharma R&D
  • Ensures adequate, timely and compliant management of clinical studies through all phases of the trial- feasibility through database lock
  • Ensures studies are in a constant state of inspection-readiness. Works with Quality Management (QM) liaisons to ensure quality oversight of studies utilizing the available tools
  • Supports staff in communications with Ethics Committees, Health Authorities, Investigational Sites and groups external to GCO
  • Coaches staff in their role in local Health Authority site inspections and follow-up activities including CAPA generation
  • Communicates with staff on program changes, policy changes and priority shifts
  • Conducts Accompanied Site Visits with Site Managers
  • Review and approve expenses; assure expenses are in compliance with the company’s policies
  • Demonstrate Leadership Behaviors in alignment with Leadership Imperatives
  • Overall accountability for planning, executing and monitoring of clinical trials through all phases of the trial feasibility through database lock, and inspection-readiness for assigned Therapeutic Area or study portfolio in country or for TCSM activities of specific role (s)
  • Appropriate and timely issue escalation to line management and study team as appropriate. Report (suspicion) of fraud or scientific/ethical misconduct
  • Strong interaction with the R&D/Local Operating Company staff and departments within GCO and outside of GCO, i.e., (Regional Therapeutic Area Experts (RTAE), GCO Early Dev. & Clinical Pharmacology as applicable,, GCO Medical Affairs regional leadership, Central Trial Coordination (CTC), Integrated Data Services (IDS), Clinical Supplies Unit (CSU), Quality and Compliance (QC) and external vendor groups, Medical Affairs)
  • Participates in special initiatives as needed and guides rollout of new processes and procedures
  • Collaborates with the RTAE on country capabilities and study placement for assigned Therapeutic Area(s) or study portfolio
  • Accountable for study feasibility in country for assigned Therapeutic area or study portfolio
  • Supports metrics review and necessary follow-up actions
  • In some instances (i.e., smaller countries) backup to country leadership
5

Clinical Research Manager Resume Examples & Samples

  • Advanced degree preferred
  • Bachelor's degree in related field and five years of experience in clinical research, or an equivalent combination of education and relevant experience
  • Excellent interpersonal skills
  • Knowledge of medical terminology
  • Experience with a diverse range of research designs and methodologies are required to successfully reach goals, along with ability to lead educational efforts and hands-on training
  • Demonstrated ability to track project needs and deadlines to ensure tasks are completed in a timely manner to facilitate project success
6

Clinical Research Manager Resume Examples & Samples

  • Ensuring the committee structure is implemented as described in the study protocols and participation on committee
  • Assisting with committee and project report preparation to PCORI, our stakeholders, and to our DSMB among other groups
  • 5 years of relevant experience
  • Bachelor’s degree in health related field
  • 10 years of experience in clinical research including research management
7

Assistant Clinical Research Manager Resume Examples & Samples

  • Experience in protocol development, data compilation and analysis
  • Knowledge of cancer as a disease process, cancer treatment modalities, and the clinical trial process
  • Expert knowledge of Federal and State regulations as they relate to research
  • Strong interpersonal, organizational and communication skills
8

Clinical Research Manager Resume Examples & Samples

  • Hire, train, supervise and manage the performance of a team of CRAs; evaluate resource needs for ongoing and planned clinical trials within the assigned team and manage the trials with available resources; develop staff to improve the individual performance and that of the team; assure that the required level of knowledge and skills are present and trial sites are managed as per SOPs by the team
  • Interact with local medical, commercial and other key stakeholders to allocate trials which best support local as well as global business interests
  • Lead local team meetings, attend business meetings and global team meetings, or as GMO representation to other meetings as assigned
  • Supervise trial execution as related to monitoring and operational aspects and overall trial performance (e.g. meet project deliverables, quality targets, timelines, recruitment, etc) in the team; recognize potential challenges, identify and resolve issues, plan on appropriate actions including manage and direct associates with problem solving at site level and escalate to Country Head or equivalent as appropriate
  • Ensures that prevailing legislation, GCP, EC/IRB and SOP requirements are fulfilled; identify potentially significant quality / compliance issues and escalate to Country Head or equivalent, as appropriate
  • Perform reviews of monitoring reports for compliance with SOPs, ensure issues identified are appropriately documented, resolved or escalated
  • Oversee trial budgets; monitor trial spending and take appropriate actions to facilitate smooth and regular refunds from Basel, and ensure timely and accurate trial cost projections and updates are provided in accordance with set deadlines
  • Accountable for the accuracy of applicable reporting systems and repositories throughout trial conduct
  • Performs periodic TMF reviews for quality
  • Coordinate and facilitate in audits and inspections, in collaboration with lead CRA
  • Liaise with local/global clinical teams (e.g. unresolved site issues) and the relevant CPO colleagues to enhance Novartis relationship with clinical sites
  • Managing CRO for outsourced clinical trials, as applicable
  • May function as a senior/lead CRA, as assigned
  • Strong interpersonal skills, team player
  • Strong problem solving, project management and leadership skills
  • Ability to perform and meet deliverables under pressure
  • Proficient in negotiation skills and effective in influencing others
  • Excellent site management capabilities with demonstrated capability to problem solve and mediate complex issues including compliance
  • Expert knowledge of ICH GCP, international standards (FDA, EMEA) and local regulations
  • Proven ability to manage teams and complex communication locally and in the global organization
9

MA Clinical Research Manager SH Resume Examples & Samples

  • A minimum of a Medical degree or Bachelor’s Degree in Life Science (Animal Science, Biology, Physiology, Nursing, Medical Technology) plus seven (7) years relevant experience, which includes a minimum of three (5) years’ experience in medical device/drug clinical research, and a minimum of (2) years experience managing (indirectly or directly) a professional staff
  • Master’s degree with a demonstrated research background is preferred
  • Experience with Good Clinical Practice (GCP) is required. Knowledge of Good Laboratory Practice (GLP) and Good Manufacturing Procedures (GMP) will be an advantage
  • Prior participation in all facets of clinical studies and prior supervisory experience required
  • Strong technical or clinical background required
  • Administering successful programs within a timeline
  • Effective communication on superior, peer, and subordinate levels
  • Ability to hire quality professionals
  • Demonstrated leadership to develop, motivate and guide subordinates to meet objectives
  • Effective written and verbal communication skills in the area of technical/clinical applications. Strong command of medical and surgical terminology
  • Demonstrated ability to persuasively influence external medical professionals to ensure project deliverables are completed on time and within budget
  • Effective analytical and problem solving
  • Ability to coordinate and lead multiple projects simultaneously
  • Knowledge of CFDA regulations concerning the conduct of pre-clinical, clinical studies and CER submissions
  • Knowledge of local, regional, and international regulations for clinical studies is preferred
  • Effective knowledge in searching medical literature and databases for clinical and technical information
  • Familiarity with biostatistics techniques and methods is an advantage
  • Effective skills in MS Excel, PowerPoint, Word and internet search engines
  • Excellent computer skills and knowledge of computerized databases for the maintenance of scientific data
  • Working knowledge of statistics and statistical methods
  • Strong command of Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) regulations
  • Ability to train others
  • Ability to work with a minimum of supervision
  • Ability to work in a highly matrixed team environment
  • Drive for results
  • Developing direct reports
  • Ethics and Values
  • Functional Technical Skills
  • Customer Focused
  • Interpersonal Savvy
  • Managing and Measuring Work
  • Building Effective Teams
  • Ability to train, mentor and develop others
10

Clinical Research Manager Resume Examples & Samples

  • 5+ years of experience in clinical research
  • 1+ years experience leading project teams or supervising direct reports
  • Previous experience in a cross-functional role that required understanding of clinical trial methodology and execution
  • Experience with International Conference on Harmonization (ICH), Good Clinical Practices (GCP), safety and data management requirements, clinical trials management, regulatory compliance (including individual global/country directives/regulations as necessary) and reporting
  • Experience managing multiple clinical trials from start to finish, including development and execution of comprehensive project plans, timelines, resource and budget planning and management
  • Experience leading clinical teams in a matrix environment
  • Experience working with contract research organizations
  • Talent development and performance management experience of staff at various levels of experience
  • Masters Degree or Ph.D
  • Clinical experience in a medical device company specializing in Cardiovascular
  • Extensive knowledge and research experience in cardiac physiology
  • Highly developed leadership skills to build and direct clinical project teams to ensure that timeline, cost, and quality metrics are met
  • Proactive and critical evaluation of all aspects of clinical development to ensure accountability at multiple levels
  • Ability to work with a continued focus on quality, efficiency and ongoing improvement
  • Strong problem solving, decision making, prioritization and organizational skills
  • Ability to lead and motivate others
11

Clinical Research Manager Resume Examples & Samples

  • 8+ years’ experience managing clinical research studies. (Master’s degree will substitute for 1 year experience; Ph.D. will substitute for 2 years’ experience)
  • Experience managing global clinical trials; industry sponsored
  • Experience providing work direction to staff and accomplishing study execution through others
  • Bachelor’s Degree in engineering, life sciences or related medical/scientific field
  • Previous personnel management
  • Working knowledge of Quality System Regulation (QSR 21 CFR 820), EU Medical Device Directive (EU MDD 93/42 EEC), and ISO 13485:2003,Good Clinical Practice(GCP)
  • Demonstrated ability to cultivate relationships with co-workers in a cross-functional environment
12

Senior Clinical Research Manager Resume Examples & Samples

  • Experience managing Investigational Device Exemption (IDE) medical device trials
  • Cost center/budget management experience
  • Experience leading and mentoring clinical teams
  • Bachelor’s degree in a technical field. Technical degree defined as engineering, life sciences or related medical/scientific field
  • Strong knowledge of monitoring functions
  • Technical degree preferred
  • Advanced written, oral, and interpersonal communication skills including proficient knowledge of medical terminology
  • Strong computer skills (MS Office products, word processing, spreadsheets, etc.)
  • Strong prioritization and organizational skills
  • Positive outlook
13

Clinical Research Manager Resume Examples & Samples

  • Required: Bachelor's degree in a related discipline
  • Preferred: Master's degree in a related discipline
  • Required: Five years of directly related experience. Previous experience in the management and coordination of clinical trials is essential
14

Senior Clinical Research Manager Resume Examples & Samples

  • 6) Prepare study budget proposal based on fair market value. Ensure the study is operated according to the budget
  • 7) Actively guide and coach CRAs in the study team
  • 8) Coordinate with data management, statistician and medical writer to generate the statistical report and study report
  • 9) Evaluate the CRO, provide evaluation assessment to line manager
  • 10) Perform co-monitoring to team members
  • 1) Provide feasibility assessment and input at project planning stage based on a satisfactory level of technical and professional skill or knowledge in position related areas
  • 2) Provide input on training curriculum based on current developments and trends in areas of expertise
  • 3) Provide local insight on global clinical trials
15

Clinical Research Manager Resume Examples & Samples

  • Assists with the design and implementation of research studies, including reviewing protocols, supporting research sites to recruit and retain study participants, and managing study operations and communications
  • Ensures compliance with government regulations throughout study implementation and when reviewing protocols, informed consent documents, reports, and manuscripts
  • Conducts site assessments visits to ensure research sites are implementing the study per protocol and to provide guidance for operational management
  • Excellent oral and written communication skills, including the ability to manage communication from multiple sources and communicate effectively with varied stakeholders (e.g. MTN network leadership, protocol leadership, FHI 360 colleagues, and research site staff)
  • Ability to analyze and interpret data, identify errors and prepare reports
  • Knowledge of sexual and reproductive health and HIV
  • Master Degree highly preferred
  • Typically requires 3-5 years of research or evaluation experience
  • Proficiency in Microsoft Office, spreadsheet software and other technology required
16

Clinical Research Manager Resume Examples & Samples

  • Manages the day-to-day operations of the Center
  • Supervises Study Coordinators/Project Managers, Lab Technician, and coordinates with 1 or 2 Clinical MD Fellows regarding task priorities and compliance of Center procedures
  • Allocates and supervises laboratory human and fiscal resources to meet timelines and productivity goals
  • Analyzes clinical trial proposals
  • Determines feasibility of conducting studies from clinical, administrative and financial perspectives
  • Develops, negotiates, and monitors trial budgets
  • Designs and implements strategies to successfully perform research trials and assumes responsibility for their timely and accurate completion
  • Designs and proposes strategic plan for successful study completion including workflow and recruitment
  • Provides ongoing supervision to assure successful study completion
  • With the Lab Fiscal Administrator monitors spending and charges on projects and assures appropriate invoicing of sponsors
  • Develops and implements lab recruitment strategy
  • Develops and evaluates recruitment strategies to be implemented by Recruitment Coordinator including spending of ~$500/week recruitment budget
  • Critically analyzes results of recruitment strategies on a continuing basis and implements cost-efficient changes
  • Responsible for lab quality control and compliance with Hospital, Sponsors, and Federal regulatory requirements
  • Designs quality assurance systems and implements necessary changes to assure compliance
  • Oversees the submission and maintenance of regulatory documentation to the IRB and sponsors
  • Interacts directly with study sponsors, the NIH, and institutional department heads/staff
  • With Director and Lab Fiscal Adminstrator drafts short and long-range strategic plans for the Center for review with Lab Director
  • Implements these plans and evaluates their success
  • Minimum of 7 years of progressively responsible project management experience in a healthcare setting (clinical research preferred)
  • Prior supervisory experience required
  • Strong analytical and computer skills including word processing and database management (ACCESS/EXCEL)
  • Ability to effectively supervise others
  • Demonstrated analytical skills and ability to logically sequence experiments to maximize research
17

Clinical Research Manager Resume Examples & Samples

  • Designs clinical studies in close collaboration with the project leader, Regulatory Affairs (RA) and other stakeholders as appropriate. This includes the setting of objectives, budgets, resources, timelines and the study protocol
  • Ensures that the study is conducted and reported according to legal requirements, relevant regulatory standard (e.g. GCP, GLP) and the applicable internal policies and procedures
  • Prepared submission dossiers, in collaboration with Regulatory Affairs, and interacts with relevant regulatory agencies (e.g. FDA, EPA, USDA) to support projects, as required
  • Develops and maintains a network of clinical and scientific contacts
  • Minimum of (3) years experience in pharmaceutical or biological research, which may include graduate study in a relevant scientific field
  • High level of organizational skills
  • Ability to complete tasks independently while working collaboratively as part of a team
  • Ability to communicate internally with colleagues representing different disciplines and with external research partners and regulatory agencies
  • Position may require 50% Travel
  • Minimum of (3) years experience in animal health clinical research and accompanying familiarity with principles of Good Clinical Practice
18

Senior Clinical Research Manager Resume Examples & Samples

  • Bachelor’s degree in engineering, life sciences or related medical/scientific field
  • Advanced degree (e.g., MS, MA, MPH, PharmD, PhD, DVM or MD) in scientific field of study
  • Strong knowledge of clinical research study design and outcomes
  • Advanced project management experience
  • Expertise in interventional medical device sector and experience managing cardiovascular medical device trials
  • Medical device industry knowledge
  • Strong leadership and negotiation skills
  • Demonstrated ability to execute effectively to achieve business results through motivating and holding individuals accountable to deliverable
  • Excellent working knowledge of the CFR & GCP
  • Willingness to accept challenging assignments and engage in relevant development activities
19

Clinical Research Manager Resume Examples & Samples

  • Lead in study design discussions to develop appropriate clinical trials to meet the NPD / LCM as needed
  • Lead in appropriate interpretation and dissemination of all evidence generated, based on EDS, including Clinical Study Reports, abstracts, manuscripts
  • Develop and deliver appropriate Global EGS / EDS to support NPD and LCM within the assigned platforms, with collaborative relationships with all relevant CR&D partners and cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics& Market Access, R&D, ensuring cross- functional alignment
  • Responsible for delivery of assigned clinical projects, through effective partnership with the Clinical Operations and Biostats and Data Management teams, to enable optimized engagement leading to delivery of clinical project commitments in compliance with all applicable regulations and company procedures
  • Ensure input and strong alignment from key regional MD CR&D leads and other strategically important countries/regions in the development of the EGS / EDS
  • Contribute in clinical scientific discussions with regulatory agencies / notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, including during sponsor regulatory inspections
  • Responsible for team’s interface and collaboration with key opinion leaders, investigators, clinical institutions, Regulatory Agencies, societies, associations
  • Foster strong relationships with external stakeholders to shape and influence relevant policies
  • Be a subject matter expert in the development of clinical evidence therapeutic areas of interest
  • Thorough understanding of clinical research science and processes along with a broad and extensive understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations
  • Demonstrated ability to build collaborative relationships with key internal and external partners and stakeholders
  • Experience in effective management of project budget processes
  • Ability to apply understanding to help define and shape clinical evidence strategies
  • Bachelor’s degree in Biological Science or related discipline is required with 8 years of leadership experience within clinical research OR 6 years with a Masters OR 3 years with a Ph.D
  • Ability to influence, shape and lead without direct reporting authority is required
  • A successful track record of fostering strong relationships with external stakeholders to shape and influence relevant policies are preferred
  • Ability to 20% international and domestic
20

Clinical Research Manager Resume Examples & Samples

  • Be a subject matter expert in the development of clinical evidence in the cancer / interventional oncology therapeutic areas of interest
  • Ability to stay current with evolving innovative minimally-invasive interventional oncology device-based therapies, including disruptive technology and associated clinical data
  • Ability to apply understanding to help define and shape clinical evidence strategies in the interventional oncology space
  • Demonstrated knowledge of minimally invasive cancer therapies, cancer pathophysiology, and interventional oncology for treatment of various solid tumors is preferred
21

Clinical Research Manager Resume Examples & Samples

  • The incumbent is accountable for the performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, MSD policies and procedures, quality standards and adverse event reporting requirements internally and externally
  • The CRM is the country point of contact (POC) for assigned protocols between ROC and CO and pro-actively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments, requiring strong collaboration with local Country Operations roles. The CRM forecasts country resource needs and serves local business needs (signs contracts, manages budgets as delegated)
  • The CRM is responsible for collaboration and relationship management with investigators for insourced and outsourced studies, with functional outsourcing vendors and other external partners. The CRM oversees country and site validations, site selection and recruitment in assigned protocols
  • The CRM collaborates internally with GMA/GHH, local PV and Regulatory Affairs to align on key decisions in countries. Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD and Regional Operations. The position requires coordination and alignment with the regional and broader organization
  • The ability to identify problems, conflicts and opportunities early and lead, analyse and prepare mitigation plans and drive conflict resolution is critical. The position requires skilful negotiation in tough situations with both internal and external groups; settle differences with minimum noise; win concessions without damaging relationships; be direct and forceful as well as diplomatic; gain trust quickly from other parties in negotiations and have an excellent sense of timing. Examples of common problems include: 1) low patient recruitment, 2) inadequate staff to meet business needs, 3) performance or compliance issues, 4) working with regulatory issues and the broader organization, and 5) resolution of conflictive situations on country level
  • Resposible for recruiting new hires, oversees development plans and assigns mentors for new hires. Provides training, support and mentoring to the CRA to ensure continuous development
  • Oversees appropropriate use of technology (data/information systems, monitoring reports, expense reporting) within area and ensures timley reporting of study information
  • 8-10 years of clinical research experience for a BS/MS/MBA/JD; 3-6 years for an MD-PhD
  • Strong understanding of clinical trial planning, (site)management and metrics
  • Strong communication, educational/pedagogic, diplomatic and empathic skills
  • Strong leadership skills (scientific and business) and proven ability to coordinate and lead local teams to high performance
  • Ability to lead across several dimensions simultaneously
22

Clinical Research Manager Resume Examples & Samples

  • 3 years clinical research managerial experience; Prefer 5 years clinical research managerial experience
  • Coordinate database development, data collection, data entry, data analytics, data reporting, and quality assurance
  • Coordinate selection of clinical outcomes measurements
  • Monitors, directs, and supervises staff in a manner that facilitates efficient level of operations
  • Prepares and conducts employee hiring interviews for appropriate positions and writes justifications for new position requests
  • Makes appropriate salary recommendations for new and existing staff and conducts annual staff performance reviews
  • Strong skills in various technologies including but not limited computer software (Microsoft Office), electronic medical records systems, digital radiographic imaging systems, and mobile technologies
  • Ability to analyze large datasets in order to identify illogical or suspicious research data
  • Knowledge and understanding of the informed consent process for prospective research studies involving human subjects
  • Coordinate submissions to regulatory bodies, including but not limited to IRB, FDA, and NIH
  • Ensure all research team members comply with all regulatory requirements
  • Independently critique study proposals and idennity conflicts, obstacles, or issues that may delay or prevent successful completion of projects
  • Oversee training of staff to ensure full compliance with study protocol
  • Assist in coordinating research projects
  • Systematically maintain and organize paper and electronic research study documents
  • Develop appropriate timelines to ensure timely completion of assigned projects
  • Work effectively with members of the research team to resolve issues interfering with completion of projects
  • Assist with the submission of research abstracts and related material to professional meetings
  • Assist with developing presentation materials, meeting agendas and annual reports as needed
  • Demonstrate initiative, good judgment, organization and attention to detail
  • Independently manage work schedule to best utilize time and skills without direction from others
  • Recognize and perform unassigned duties as needed
  • Regularly assist and/or train others as need is perceived
23

Oncology Clinical Research Manager Resume Examples & Samples

  • The incumbent is accountable for the performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Merck policies and procedures, quality standards and adverse event reporting requirements internally and externally
  • The CRM is the country point of contact (POC) for assigned protocols between Region and Country Operation and proactively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments, requiring strong collaboration with local Country Operations roles
  • The CRM forecasts country resource needs and serves local business needs (signs contracts, manages budgets as delegated)
  • The CRM is responsible for quality and compliance for assigned protocols in the country and oversees CRAs and/ or CTCs and training compliance. Performs quality control visits, reviews Monitoring Visit Reports and escalates performance issues and training needs to functional vendor and internal management as needed
  • The CRM is responsible for collaboration and relationship management with investigators for insourced and outsourced studies, with functional outsourcing vendors and other external partners
  • The CRM oversees country and site validations, site selection and recruitment in assigned protocols
  • The CRM is responsible for clinical trial education to sites, and acts as the country POC for programmatically outsourced trials for assigned protocols. In collaboration with CRD, represents Merck/MSD in Pharma industry issues and in seeking influence in external R&D environment
  • The CRM collaborates internally with GMA/GHH, local PV and Regulatory Affairs to align on key decisions in countries
  • Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD and Regional Operations. The position requires coordination and alignment with the regional and broader organization
  • Examples of common problems include
  • Strong understanding of clinical trial planning, (site) management and metrics
  • Excellent oral and written English language skills
  • Problem solving and conflict resolution
  • Has demonstrated the following leadership behaviors
24

Asst Clinical Research Manager Resume Examples & Samples

  • Oversees registration of protocol patients with QACT, study group registrar and pharmaceutical company as outlined in protocol
  • Assumes responsibilities for data management. Maintains schedules and procedures necessary for timely and complete data collection
  • Oversees and coordinates the purchase, receipt, inventory and distribution of equipment utilized in the conduct of clinical trials
  • Minimum of 3-5 years of related experience preferred
  • Must have the ability to function independently, with little supervision
  • Computer skills including the use of Microsoft Office
25

Clinical Research Manager Resume Examples & Samples

  • LI-NS1
  • Extensive experience in the pharmaceutical/medical field with at least 5 years of clinical trial management/monitoring experience recommended
  • A scientific/healthcare related degree
  • Relevant therapeutic area experience (preferred)
  • Strong project leadership skills
  • Effective team building and teamwork skills
  • Knowledge of SOPs/regulations relevant to clinical research in Switzerland
  • Fluency in written and spoken German, English and French
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Clinical Research Manager Resume Examples & Samples

  • The incumbent is accountable for the performance for assigned protocols in a country in
  • The CRM is responsible for collaboration and relationship management with
  • 8-10 years of clinical research experience for a MS/MBA/JD; 3-6 years for an MD-PhD
  • Experience in management of Trails in CNS in strogly preferred
  • Has demonstrated the following leadership behaviours
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Clinical Research Manager Resume Examples & Samples

  • Bachelor's degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
  • Minimum of 5 years’ experience in the pharmaceutical industry, at a CRO or hospital including clinical research experience. Effective communication and leadership skills and ability to foster team productivity and cohesiveness
  • Experience mentoring/coaching others. Experience with people management is desirable. Ability to lead hiring, training, development and evaluation of people. Solid decision-making and financial management skills
  • Strong knowledge on drug development, clinical research operations and regulatory requirements including GXP, ICH and local regulations or FDA CFRs (if applicable). Strong ability to synthesize and evaluate data generated from various reports and sources
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Clinical Research Manager Resume Examples & Samples

  • The CRM is the country point of contact (POC) for assigned protocols between ROC (Regional Operations Center that is in charge of Project Management) and country operations and pro-actively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments, requiring strong collaboration with local Country Operations roles
  • The CRM is responsible for quality and compliance for assigned protocols in the country and oversees CRAs and training compliance. Performs quality control visits, reviews Monitoring Visit Reports and escalates performance issues and training needs to functional vendor and internal management as needed
  • The CRM is responsible for clinical trial education to sites, and acts as the country POC for programmatically outsourced trials for assigned protocols. In collaboration with CRD, represents MSD in Pharma industry issues and in seeking influence in external R&D environment
  • The CRM collaborates internally with Medical, Business, pharmacovigilance and Regulatory Departments to align on key decisions in countries. Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD and Regional Operations. The position requires coordination and alignment with the regional and broader organization
  • Master in Science (or comparable). Advanced degree (MD, PhD) possible but not required
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Clinical Research Manager Resume Examples & Samples

  • Responsible for conducting Nobel Biocare Sponsored Studies as well as supporting Investigator Initiated Studies
  • Responsible for the design, implementation, monitoring, supervision and direction of clinical studies
  • Identifying/selecting investigators who will be responsible for conducting studies
  • Responsible for running investigator’s meetings
  • Responsible for study site visits and meeting research objectives
  • Managing compliance and protocol activities
  • Developing and writing clinical study protocols
  • Designing data collection forms, known as case report forms ( CRFs)
  • Organizing ethics committee submissions with the study sites
  • Managing regulatory authority applications and approvals when applicable
  • Managing statistical evaluation of study results with the support of independent statisticians
  • Supporting other departments with clinical content and knowledge
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Clinical Research Manager, Assoc.director Resume Examples & Samples

  • 1) low patient recruitment,
  • 2) inadequate staff to meet business needs,
  • 3) performance or compliance issues,
  • 4) working with regulatory issues and the broader organization, and 5) resolution of conflictive situations on country level
  • 10 years clinical research experience is a minimum requirement
  • Specific Experience
  • Project management experience with positive records of success
  • People management experience is desirable
  • Profound expertize in Clinical Study oversight and Site management
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Clinical Research Manager Resume Examples & Samples

  • MA/MS, Doctoral or higher degree in related field
  • Prior experience conducting semi-structured and structured clinical interviews in children (e.g. Kiddie Schedule for Affective Disorders and Schizophrenia, Children's Depression Rating Scale, Pediatric Anxiety Rating Scale, and Young Mania Rating Scale) and adults (e.g. Structured Clinical Interview for DSM) and experience with good clinical practice (GCP) guidelines
  • Experience running NIH sponsored research studies
  • Necessary patience and ability to work with children and their families
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Clinical Research Manager Resume Examples & Samples

  • Use effective training tools to integrate clinical studies into clinic daily operations in order to minimize study deviations and maximize patient participation opportunities
  • Facilitates timely issue escalation and resolution for study teams and clinic issues as it relates to clinical research execution
  • Facilitates facility teammate training and clinical study execution to ensure the effective execution of research tasks performed by the clinic staff
  • Understands and promotes compliance with all applicable healthcare and research regulations
  • Coordinates with Quality Assurance to ensure teammates are trained on Standard Operating Procedures, research regulations and applicable healthcare regulations
  • Participates in Central Sites operations review on a quarterly basis
  • Assists the Director of Clinical Research Integration in preparing monthly operational updates for senior leadership
  • Other duties assigned
  • BS/BA required. Science area of study preferred
  • Minimum five (5) years of Clinical Research Experience or equivalent experience
  • Ability to manage multiple projects, meet deadlines, and adjust priorities appropriately in an evolving work environment with shifting time frames; self-starter with high degree of initiative, urgency, and follow through
  • Innovative, analytical thinker with demonstrated ability to perform root cause analysis, prepare and implement action plans, and lead improvement initiatives
  • Travel required, less than 50%
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Clinical Research Manager Resume Examples & Samples

  • Accountable for the performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, MSD policies and procedures, quality standards and adverse event reporting requirements internally and externally
  • Responsible for quality and compliance for assigned protocols in the country and oversees CRAs and/or CTCs and training compliance. Performs quality control visits, reviews Monitoring Visit Reports and escalates performance issues and training needs to functional vendor and internal management as needed
  • Responsible for collaboration and relationship management with investigators for insourced and outsourced studies, with functional outsourcing vendors and other external partners. The CRM oversees country and site validations, site selection and recruitment in assigned protocols
  • Collaborating internally with Medical Affairs, local PV and Regulatory Affairs to align on key decisions in countries. Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD and Regional Operations. This position requires coordination and alignment with the regional and broader organization
  • Master in Science (advanced degree (MD, PhD) possible but not required)
  • 8-10 years of clinical research experience for a MSc; 3-6 years for a MD-PhD
  • Negotiation skills with both internal and external stakeholders
  • Excellent oral and written Dutch and English languages skills
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Clinical Research Manager Resume Examples & Samples

  • Manage and oversees the operational execution of sun care and foot care studies in humans. This includes but is not limited to the guidance and management of internal and external CRAs
  • Manage and oversee the activities of CROs and other operational contractors and third parties involved in the conduct of CH studies. This includes that the incumbent ensures that all applicable guidance’s including, however not limited to ICH Guidelines, GCP and SOPs are followed in all aspects of the studies
  • Select and qualify study sites, conduct pre-study visits, study initiations, carry out interim monitoring visits with the timely completion of reports and oversee these activities
  • Develop or contribute to protocol development as necessary
  • Manage the timelines and budgets of the assigned studies
  • Education: Bachelor’s degree or related degree in Life Sciences, Health Sciences or related field, or a professional nursing or medical qualification
  • Experience: Minimum of 5-6 years’ experience in clinical biomedical development, preferably with 2-3 years’ experience managing the operational part of clinical studies
  • Excellent written and verbal communication skills, interpersonal and organizational skills
  • Good knowledge in in tracking clinical study costs against the budget
  • Knowledge of, and adherence to ICH/GCP Guidelines, and as well as appropriate guidelines for clinical monitoring
  • Broad knowledge and cross functional understanding of clinical trial methodology and logistics
  • Competencies: Team player with ability to work independently to accomplish objectives within timelines established by the Clinical Trial Manager and /or Project Teams, and the ability to work in a matrix organization
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Clinical Research Manager Resume Examples & Samples

  • Applies critical thinking skills and utilizes quality data and conceptual knowledge in the development of the department vision and operational plan. Hires clinical research staff and has responsibility for delegating tasks, monitoring workloads, and evaluating job performance. Oversees the day-to-day activities of the clinical research program and provides direct supervision to the clinical research staff. Serves as liaison between study sponsors and PIs; serving as the key coordinator for multi-center trials involving subject enrollment. Demonstrates the ability to create a shared vision applies critical thinking skills and utilizes financial and quality data and conceptual knowledge in the development of the department vision and operational plan. Orchestrates complex change and acknowledges the psychological transition on self and others. Involves stakeholders and experts in planning, designing, and redesigning change. Accountable for the recruiting, retaining, and developing of clinical research staff
  • Creates developmental paths to increase the expertise of staff. Initiates innovation in staff development, clinical orientation, continuing education, and supports specialty certification. Develops strategies to maximize timely completion of disease center specific CRFs and data collection forms within standard of practice guidelines. Monitors and facilitates completion of all protocol required data elements within CTMA and ensure all electronic data capture is complete and accurate Develops strategies to ensure protocol compliance and patient safety. Demonstrates a passion for developing others, enthusiastically and expertly precepts new hires during the orientation process and serves continuously as a mentor. Takes responsibility for identifying his or her ongoing professional development needs and independently seeks resources and opportunities to meet those needs, such as through membership in nursing, oncology, or research organizations
  • Ensures that staff practices in accordance with established Good Clinical Practice guidelines. Assists in institutional review board (IRB) document preparation and submission. Supports and assist in research coordination for high profile/high risk clinical trials. Creates a caring and compassionate patient focused experience by building healing relationships with patients, families and colleagues. Disseminates new knowledge and innovations through presentations, posters, and publications. Practices solid communication skills and is able to articulate and translate pertinent patient, protocol and staff information
  • Establishes and maintain a collaborative working relationship with all ancillary departments and staff. Develops and maintains productive working relationships internally and externally by building teams and relationships through mentoring and modeling uplifting and positive communication. Note: The above statements are intended to describe the general nature and level of work being performed by people assigned this job. They are not exhaustive lists of all duties, responsibilities, knowledge, skills, abilities and working conditions associated with the job
  • Monitors dashboard and quality indicators to meet organizational goals and develops and implements new processes to address specific concerns and improve quality. Supports and encourages staff involvement in the development and implementation of quality improvement initiatives. Assists in the development of departmental standards of practices
  • Three years (3) of nursing experience required
  • Minimum of 3 years progressive leadership experience required
  • Relevant clinical experience in either oncology or research preferred
  • BSN required
  • Masters degree in Nursing or related health care field preferred
  • Must be able to demonstrate the knowledge and skills necessary to provide care and/or interact appropriately to the ages of the patients served by the department Must have excellent organizational skills, meet requests from multiple individuals, and respond appropriately to sudden workload changes. Must possess excellent presentation skills and written and verbal communication skills
  • Knowledge of the adult learning principles
  • Solid/strong/good or higher on most recent performance evaluation and maintained in current practice
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Clinical Research Manager Resume Examples & Samples

  • Ph.D. in the social sciences with an emphasis on disparities-related fields, such as medical sociology, anthropology, or epidemiology
  • Five years of experience in administration and teaching preferred
  • Preferred candidates will have established recognition in diabetes health equity initiatives or committees at the state and national levels, and experience with education curriculum development an accreditation
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Senior Clinical Research Manager Resume Examples & Samples

  • Responsible for the day to day management of clinical trials
  • Manages activities performed by direct reports, consultants and/or Contract Research Organizations
  • Demonstrated ability to manage people
  • Managing clinical trials, or equivalent project management experience for at least 3-5 years
  • Proficient in GCP, ICH guidelines and other US and international clinical regulatory requirements
  • Experience in IVD is preferred
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Clinical Research Manager Resume Examples & Samples

  • Lead the clinical study design proposal contributions for all projects between key stake holders
  • Lead clinical study design inputs into the study plan to support approval of governance approved product label
  • Ensure compliance of all clinical study activities with required global, regional and local regulatory and quality requirements and internal Regulatory/Research & Development and quality policies
  • Lead the clinical study plan contributions on global Research & Development project teams as required
  • Develop and lead the personal and professional development programs of clinical team personnel
  • Lead the Clinical Studies team in the development of clinical study protocols, all clinical research contracts and assist conducting pivotal clinical studies as required
  • Lead the execution of any global clinical studies required for the Oceania region Lead the development of the Clinical Procedure documentation and Clinical Quality SOP system
  • Lead the clinical contributions in the development of the project scoping document; and
  • Lead all ORD clinical program communications to local, regional and global stakeholder groups
  • Bachelor Science/Animal science or equivalent) or Bachelor of Veterinary Science
  • History of leading Clinical studies, exposure to data audit, and data analysis in sheep/cattle/dog/cat parasitology studies is essential
  • Comprehensive understanding of the principles of industrial operations and Animal Health regulatory processes is essential
  • Experience in managing large scale dairy studies highly desirable
  • Experience in managing biological clinical studies highly desirable; and
  • You must be meeting performance expectations in your current role
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Stem Cell & Gene Therapy Clinical Research Manager Resume Examples & Samples

  • Early Phase, biologics and/or stem cell clinical trial experience strongly preferred
  • Previous supervisory experience preferred
  • Strong organizational and project management skills desired
  • Proficiency in Microsoft Office and database applications
  • Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices
  • Demonstrated managerial experience
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Clinical Research Manager Resume Examples & Samples

  • Supervise clinical research staff for all aspects of conducting a complex and multi-site clinical study
  • Develop and implement plans, schedules, and standard operating procedures under the guidance of study leadership for assigned sites
  • Collaborate effectively with others to ensure proper progress in enrollment milestones and completion of studies
  • Participate in local and national collaborative calls related to program operations
  • Train new staff in preparation and conduct of clinical trials and protocol specific operations
  • Supervise and provide oversight and guidance as needed to research staff; Supervise activities of subordinates, if assigned
  • Collect and process specimens to meet study requirements, including saliva, urine and intravenous blood samples
  • Provide oversight for the preparation, review, submission and maintenance of regulatory activities/submissions within our team to the national IRB, ensure accuracy and timeliness of distributing regulatory updates to all collaborative parties
  • Implement successful plan to identify potential participants
  • Determine best method/s to identify potential participants for research protocol (advertisements, chart reviews, monitoring of clinic schedule, etc.) and prepare accordingly
  • Maintain a detailed tracking system for participants considered for enrollment. Track progress at regular intervals and report out to PI and study team
  • Proactively take initiative to ensure enrollment stays on track with the project timelines
  • Maintain master files for clinical research protocols
  • Master’s degree in a field appropriate to the area of assignment AND three years related research experience; OR, Bachelor’s degree in a field appropriate to the area of assignment and four years related research experience; OR, Any equivalent combination of experience, training and/or education
  • Previous human subjects training (e.g., CITI certification) and four years’ experience in clinical research with direct recruitment and enrollment responsibilities
  • Ability to work both independently and with a team, resolving issues with a positive outcome
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Clinical Research Manager Gastrointestinal Service Resume Examples & Samples

  • Staff Management: Supervise the training/development and performance management for direct and indirect reports throughout the service
  • Protocol Development: Oversee all aspects of the protocol development process including protocol, consent and other essential study document drafting. Must be able to write protocols
  • Financial Management: Works closely with the appropriate stakeholders, forecast trial resource needs, and assesses staffing resource needs for program and senior leadership to ensure appropriate line function allocations
  • Quality Assurance: participate in routine audits for data quality, regulatory compliance, patient safety issues related to clinical trial. Communicates and ensures compliance with company policies and procedures, quality standards and improvement initiatives
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Clinical Research Manager Resume Examples & Samples

  • Marian Hospital Medical Center (Santa Maria, CA)
  • Arroyo Grande Hospital (Arroyo Grande, CA)
  • French Hospital & Medical Center (San Luis Obispo, CA)
  • Pacific Central Coast Clinics (Santa Maria, CA)
  • St. John’s Hospital (Oxnard, CA)
  • Bakersfield Memorial Hospital (Bakersfield, CA)
  • Mercy Merced Hospital (Merced, CA)
  • A minimum 3 years of full-time experience in research administration in a hospital or clinic setting or closely related field required
  • Combination of 3 or more years experience in clinical trial budget preparation, research personnel management or general health related business management required
  • A thorough understanding of regulatory requirements related to the oversight of research by Institutional Review Boards
  • A minimum 3 years of experience in clinical research, or closely related discipline required
  • Thorough knowledge of fiscal planning, principles and techniques of administrative management including organization, planning, staffing, training and reporting
  • Knowledge of GCP, ICH, Federal, State and other general regulatory research oversight requirements
  • Scientific writing and grant development experience preferred
  • Demonstrated ability to work with all members of the research community including principal investigators, clinical coordinators, students and all levels of hospital administration and clinical program management
  • Ability to interpret research protocol information in relation to completing a Medicare Coverage Analysis, developing clinical trial budgets, understanding federal regulations/guidelines, and institutional policies
  • Exercise sound judgment and make recommendations and/or decisions regarding research policies and procedures
  • Experience with web based IRB submission and IRB management applications and tools. Advanced experience using spreadsheet, database and word processor applications as well as computerized tracking systems
  • Effective organizational skills; effective follow-through, and commitment to excellence
  • Ability to produce timely and competent work with minimal supervision
  • Take a leading role in the refinement of the service area and facility research mission, strategic and business plans in support of current and future research programs
  • Support and promote existing research programs including Cardiology, Interventional Cardiology, Oncology, Neuro/Stroke, student and data research
  • Assist the facility Accountable Executive for Research by developing, planning, analyzing, evaluating, advising, implementing and directing specific departmental activities with the goal of maximizing efficiency of various management control systems, programs, policies, work methods and procedures
  • Collect and analyze data to develop specific recommendations and advice for changes in work operation and other key actions for the purpose of improving the efficiency, quality of programs, fiscal accountability and operations management
  • Collaborate regularly with Research Institute management, IRB staff and research manager staff. Attend monthly Research Institute and IRB meetings as necessary
  • Execute institutional policies and procedures to ensure Dignity Health’s compliance with Federal, State and other regulations governing the conduct and management of research
  • Proactively seek new research opportunities and provide community outreach regarding the service area and facility research programs and research capabilities
  • Seek opportunities to collaborate with other Dignity Health facilities to expand research program collaborations beyond the facility and service area
  • Establish research budgeting and financial reporting procedures including monitoring and controlling research study specific and general research program expenditures
  • Administer a general research support services budget including a cost effective mix of industry (commercial), government, grant, hospital foundation and investigator sponsored research
  • Establish appropriate procedures to monitor hospital and investigator compliance with sponsor clinical trial agreements, grant awards and other research related financial agreements
  • Invoice research sponsors for administrative and other costs as necessary in the review of new and ongoing research
  • Act as liaison between all members of the service area research community including Physicians/Principal Investigators, facility Accountable Executives, facility Administration, Dignity Health Research Institute, IRB Chair, IRB committee members & staff, Dignity Health Legal, Dignity Health Corporate Compliance and government agencies
  • Monitor the progress of research activities; develops and maintains records of research activities, and prepares periodic and ad hoc reports, as required by investigators, administrators, funding agencies, and/or regulatory bodies
  • Develop appropriate training/educational materials along with the Dignity Health Research Institute for all members of service area research community
  • Responsible to work with the Dignity Health Research Institute to identify and develop efficient processes for general administrative oversight to increase productivity and provide improved services overall to the service area research community
  • Coordinate outreach and research support services with the hospital's charitable foundation with regard to seeking research funding and grant opportunities
  • Meets all mandatory requirements of the position including mandatory training, classes, licensure/certification, employee health requirements, and adherence to Dignity Health's Code of Conduct
  • Other job skills required: Demonstrates appropriate time management skills. Demonstrates effective verbal and legible written communications and interpersonal skills with associates, community and other customers. Provides accurate and helpful information and instructions to departmental and hospital customers. Accurate listening skills while checking understanding, with appropriate follow through on requests for information and/or services
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Site Clinical Research Manager Resume Examples & Samples

  • Bachelor’s Degree in a related healthcare, science or administration field, required
  • Minimum of three (3) years relevant experience as a clinical research associate or clinical research coordinator. Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Associate (CCRA) or equivalent certification, preferred
  • Sound knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs
  • Solid teamwork, organizational, interpersonal, and problem solving skills
  • Ability to multi-task, work under time constraints, work independently and cooperatively with interdisciplinary teams
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Clinical Research Manager Resume Examples & Samples

  • Manages a Practices clinical research program and operations in accordance with USON SOP and ICH GCP guidelines. Responsible for ensuring at the administrative level that all research activities are coordinated with affected departments within the practice
  • Collaborates with the Site Research Leader (SRL), physicians of the practice and research committee in the process of study selection for the research program. Develops and implements research budgets that include accrual targets and financial objectives for each research location, in collaboration with practice management. Responsible for promoting or marketing research programs to the practice, community and referring physicians. Coordinates research activities with other (non-USOR) bases or sponsors
  • Leads meetings and facilitates groups to achieve desired results. Utilizes facilitation tools to ensure participation, innovation and decision-making among group; effectively uses group process techniques
  • Develops and implements short term goals that align with the companys vision and business goals. Cascades goals down to staffs annual objectives
  • Develops and maintains current policy and procedural manual and communicates plans appropriately throughout the organization. Coaches and develops staff. Provides on-going job related education and training of staff. May develop training materials
  • Responsible for the recruitment, interviewing, recommending hires, assessing performance, recommending salary changes, progressive discipline, and retention of staff. Enforces adherence to USON policies
  • Other duties as requested or assigned
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Clinical Research Manager Resume Examples & Samples

  • Specialty/Department/Practice –Oncology Research
  • Shift/Schedule – Day Shift
  • Bachelor’s Degree or equivalent required
  • 4 years of experience required
  • RN license preferred, CCRC certification preferred
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Clinical Research Manager Resume Examples & Samples

  • Theoretical knowledge of a biological science such as Biology, Microbiology or a related field
  • Extensive experience and expertise in conducting clinical trials. Proven experience in research protocol start up procedures, marketing, outreach, recruitment, and screening of research subjects. Preferred at least 3 years’ experience
  • Demonstrated ability to take patient history, evaluate patient problems and provide complete documentation in patient record
  • Demonstrated ability to develop and implement effective patient scheduling/appointment system and coordinate the flow or necessary documents and referral services
  • Demonstrated experience collecting, evaluating, and interpreting routine standard lab tests on human subjects, i.e. blood tests, vital signs. Ability to read and interpret lab results and summarize scientific data. Experience processing and shipping human blood samples for onsite and offsite labs
  • Extensive experience using EPIC
  • Experience supervising or providing work direction to other researchers in a lab environment
  • Demonstrated knowledge of research methods in Cardiac Electrophysiology preferred
  • Advanced skills in data analysis, presentation and publication in journal articles
  • Demonstrated knowledge of medical billing and collections guidelines and procedures
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Clinical Research Manager Subspecialty Medicine Resume Examples & Samples

  • Staff Management: Supervise the training/development and performance management for direct and indirect reports throughout the programs
  • Clinical Trial Reporting: Generate protocol portfolio status reports for key stakeholders. Implements solutions for streamlining and accelerating the monitoring and review of clinical trials to significantly increase accrual to clinical trials, data cleaning, data quality, and trial completion
  • Database Management: Oversees data management aspects of research databases such as the Clinical Research Database (CRDB), department specific patient databases, and the Disease Management System (DMS) as needed
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Clinical Research Manager Resume Examples & Samples

  • Address and resolve all internal and external issues related to site management for assigned research projects
  • Participate in investigator meeting and/or investigator and site training sessions (as applicable)
  • Oversee and ensure efficiency of the clinical trial start-up process
  • Prepare for and respond to internal and external sponsor audits
  • Over see close-out procedures, including financial reconciliation of all revenue and expenses
  • Manage staff in accordance with organization's policies and applicable regulations; responsibilities include planning, assigning and directing work flow; appraising performance, guiding professional development and mentors new research team members
  • Participate in the selection and on boarding process for new associates by conducting candidate review and participating in the interviewing process; assist with the on boarding training for new associates in conjunction with Human Resources and Sr. Leadership
  • Use the Clinical Trial Management System (CTMS) to track metrics, timelines and other data to assure quality, timelines and budgets are managed according to expectations; alerts the research team(s) and leadership of significant risks (with mitigation plan) and potential delays (with action plan)
  • Review and develop a familiarity with the contract or award terms and conditions; works with investigator to assure that the study is in compliance with all terms and conditions, health and safety protections for research participants, and any financial terms and conditions
  • Contribute to business development activities and participate in proposals as applicable; promotes growth and ensure operational profitability
  • Liaise and work effectively with multidisciplinary, ancillary, inter-professional research teams, sponsors and IRB to maintain accurate communication of costs, policy changes, fiscal requirements and other regulatory issues
  • Communicate effectively to the research team regarding the scientific center goals and the importance of serving our customers
  • Must possess in-depth knowledge of Good Clinical Practices (GCPs) provided by the International Conference on Harmonization (ICH)
  • Consistently demonstrate support for compliance in the performance of job duties and responsibilities by a) developing and maintaining knowledge of, and performing job functions in compliance with rules, regulations, policies and statutes that affect his/her job; b) maintaining knowledge of and performing job functions in compliance with MedStar Health and MedStar Health Research Institute policies and procedures; and c) reporting compliance concerns in an appropriate and timely manner
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Clinical Research Manager Resume Examples & Samples

  • Directs the Clinical Research operations in administrative, budgetary and fiscal matters, preparing analysis as required for immediate and long range management planning
  • Manage resources of assigned Clinical Research multiple areas to accomplish specified goals/objectives
  • Responsible for coordinating activities administered by the research program or service area and in the development and implementation of procedures for the Clinical Research in multiple program/service area
  • Responsible for assisting in the interpretation and implementation of policies and procedures as they apply to assigned areas of responsibility. May recommend changes on policy/procedures as necessary
  • Daily supervises research coordinators and support staff engaged in the carrying out of research and clinical protocol
  • Coordinates special studies or projects as directed by the Assistant and Director of the program
  • Acts as liaison between program/service sand outside agencies and general public
  • Performs related duties as required or deemed appropriate to the accomplishment of the responsibilities and functions of his/her area
  • Plans and directs clinical research activities for an assigned section for multiple clinics across UF Health
  • Participates in promoting Human Subjects Protections within Clinical Research areas locally and within the state
  • 5 years Clinical research experience in Cardiology/Stem Cell Area
  • Ability to communicate effectively with medical and research staff, patients and families
  • Strong computer skills and demonstrated ability to work accurately in a detail-oriented,busy medical environment
  • Bachelors in Nursing
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Clinical Research Manager Thoracic Medicine Resume Examples & Samples

  • Staff Management: Supervise the training/development and performance management for a large team of direct and indirect reports throughout the programs
  • Protocol Development: Oversee all aspects of the protocol development process including protocol, consent, budget and other essential study document drafting. Must be able to write protocols and develop budgets
  • Financial Management: Works closely with the appropriate stakeholders, forecast trial resource needs, and assesses staffing resource needs for program and senior leadership to ensure appropriate line function allocations. As needed, assist the PI and Grants Mgmt. Specialist to help with financial information for grant preparation
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Clinical Research Manager Resume Examples & Samples

  • Act as a resource for investigators and support staff on pre-trial functions including budget development, contract negotiations and IRB applications. Advise department study investigators and support staff on administrative and regulatory aspects of human subject research
  • Project (protocol) management. Act as liaison to the Faculty Disease Committees and Principal Investigators to ensure a collaborative atmosphere and guide the processes for protocol approval providing research support and management as appropriate following current MCW and Cancer Center CTO policy, procedures and guidelines
  • An active member of CTO Leadership team with focus on collaboration and continuous process improvement
  • Manage the disease team resources to provide adequately trained staff, project staffing needs, assign projects, and monitor staff performance
  • Develop and implement department policies, procedures and organizational tools to ensure compliance with MCW, state and federal standards
  • Manage data systems supporting research activities including, but not limited to, EPIC, OnCore and eBridge. Correspond with IRBs as needed
  • Assist in the development and management of budget
  • Recruit and train clinical research staff nurses and clinical research coordinators; develop and implement standardized expectations for all subordinates; assess, monitor and evaluate work load and performance. Mentor and direct staff to achieve research goals following all relative policies, procedures and guidelines
  • Assist in process development and support for the ongoing implementation and use of the clinical trial management system, OnCore
  • Act as a liaison between Cancer CTO Administration and research staff. Work closely with other departments and external agencies to advance the department’s research goals. Collaborate with MCW Office of Research, Grants and Contracts, IRB and other offices and committees to define processes and insure consistency
  • Serve as primary site contact for Foundation Trials or NCI Cooperative Group as appropriate
  • Develop, implement and monitor department research QI activities. Implement and conduct quality control processes to ensure the highest data and research standards
  • Develop clinical review data review plan and check specifications. Utilize quality improvement tools & statistical process control to facilitate improvement of systems & processes
  • Perform as a Research Nurse/Study Coordinator for select projects and/or patients
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Oncology Clinical Research Manager Resume Examples & Samples

  • The CRM is the country point of contact (POC) for assigned protocols between Trial-level and Country-level Operation and proactively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments, requiring strong collaboration with local Country Operations roles
  • The CRM is responsible for quality and compliance for assigned protocols in the country and oversees CRAs and/ or CTCs and training compliance
  • Performs quality control visits, reviews Monitoring Visit Reports and escalates performance issues and training needs to functional vendor and internal management as needed
  • The CRM is responsible for clinical trial education to sites, and acts as the country POC for programmatically outsourced trials for assigned protocols
  • In collaboration with CRD, represents Merck/MSD in Pharma industry issues and in seeking influence in external R&D environment
  • The ability to identify problems, conflicts and opportunities early and lead, analyses and prepare mitigation plans and drive conflict resolution is critical
  • The position requires skillful negotiation in tough situations with both internal and external groups; settle differences with minimum noise; win concessions without damaging relationships; be direct and forceful as well as diplomatic; gain trust quickly from other parties in negotiations and have an excellent sense of timing
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Assistant Clinical Research Manager Resume Examples & Samples

  • Identifies operational, logistical, and regulatory challenges related to the conduct of clinical trials and acts as a leader in overseeing their resolution
  • Oversees processing of protocols through DFCI Institutional Review Board (and other institutions' IRBs) when appropriate. Oversees regulatory process for related studies. Collaborates with the Office for Human Research Studies (OHRS)l, the Quality Assurance for Clinical Trials (QACT), and the Clinical Trials Office (CTO) to fulfill federal requirements governing human clinical trials. Completes all annual review requirements
  • Collaborates with the DFCI QACT to develop study forms, database information, and to establish guidelines for monitoring data quality control
  • Oversees study enrollments and appropriate protocol treatment and follow-up care for patients in clinical trials
  • Assists the principal investigator in developing the protocol budget, in collaboration with Research Administration and the Grants and Contracts offices. Work with grant managers and other financial managers in the reporting and accounting of these funds
  • Responsible for the recruitment and oversight of coordinator staff as well as ensures that staff has completed mandatory training in a timely manner. Develops and oversees a program specific on-boarding and orientation process and participates in annual performance evaluations and competency assessments of research staff
  • Assists the principal investigator in preparing manuscripts for publication
  • Provides in-service training and serves as a resource to other clinical personnel including physicians, nurses, pharmacists and other allied health professionals regarding clinical trials, protocols, GCP guidelines, federal regulations and site SOPs
54

Clinical Research Manager Resume Examples & Samples

  • Interaction with Sponsors/CROs, IRBs, patients/subjects, nursing and medical staff of various clinics, hospitals and physicians’ offices
  • Able to perform Clinical Research Coordinator role
  • Coordinate multiple and complex protocols
  • Provide a leadership role in developing, implementing and evaluating the conduct of studies
  • Oversee and supervise the startup, conduct and close-out of studies assigned to the team
  • Provide quality control review of subject/patient charts, data collection, data entry and data integrity for all studies assigned to the team
55

Clinical Research Manager Resume Examples & Samples

  • Bachelor's degree in related area and at least two years of supervisory experience
  • Two or more years of clinical research or regulatory affairs experience, Solid understanding of clinical trials policies, procedures, and regulatory issues. Experience and knowledge of IRB policies and procedures as well as FDA regulations relating to Investigational New Drugs
  • Working knowledge of clinical or laboratory research, clinical trial recruitment, eligibility, protocol adherence, quality data submission and adverse event reporting
  • Broad knowledge of clinical research concepts, federal, state and local laws and regulations, and industry requirements regarding the proper conduct of clinical trials. Broad theoretical and operational knowledge of clinical and patient safety standards and regulations relating to clinical research
  • Broad knowledge of all phases of clinical research, from study startup through closeout and primary publication and presentation. Knowledgeable about clinical studies involving complex trial design issues
  • Critical thinking skills to evaluate issues and identify a potential solution
  • Professional attitude. Ability to respond well to changing priorities. High degree of motivation and innovation; commitment to excellence
  • Ability to effectively manage multiple priorities, prioritize projects and meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities
  • Ability to perform all commonly applicable functions in word processing and spreadsheet software. Effectively uses campus' clinical information and documentation application programs. Proven ability utilizing clinical trial management systems
  • Ability to work independently. Ability to respond well to changing priorities
  • Demonstrated management skills supervising, maintaining and developing clinical staff within the study team, and acting as a mentor for professional staff and conducting reviews and performance evaluations. Effectively manages multiple important priorities
  • Demonstrated ability to work collaboratively with other cross-functional teams and people with a wide range of educational backgrounds. Demonstrated ability to interface with commercial, regulatory, federal and other members of an extended study team. Ability to influence / persuade
  • Demonstrated ability to organize research work functions in an efficient and effective manner. Great organizational skills applied to personal work and improving organization of assigned staff and trial
  • Good interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership, mentorship. Interpersonal skills to effectively motivate others. Works well with others to achieve common goals. Ability to cultivate relationships with multiple stakeholders at various levels of administration
  • Good communication skills; both verbal and written. Clear and concise communicator
  • Master's degree in related area and / or equivalent experience / training
  • GCP / Human Subjects Protection certification
56

Clinical Research Manager Resume Examples & Samples

  • Five years of clinical research experience in an academic health center, pharmaceutical, biotechnology, or CRO industry or equivalent
  • Clinical Research Certificate
  • Ensures work is done on time in a high quality manner
  • Knowledge of clinical pharmacology and pathophysiology, and food allergy research
  • Demonstrated excellence in complex project management and effectively managing multiple projects/priorities
  • Experience managing cross-functional teams or work groups as well as direct reports
  • Demonstrated understanding of pharmaceutical regulatory requirements and impact on development of clinical trials
  • Strong regulatory knowledge and ability to perform monitoring of CRFs, GCP and GMP. This position must know IRB regulations and how to perform IRB submissions. Working knowledge of FDA procedures as applicable, and ICH-GCP and relevant SOPs
  • Disciplined work approach with the ability to function independently, take initiative and effectively problems solve issues
  • Customer service oriented both internally and externally with strong organizational, interpersonal and communication skills
57

Clinical Research Manager Resume Examples & Samples

  • Risk management process
  • Full support of Regulatory / Clinical Strategy, including
  • Preparation of clinical knowledge scientific documentation
  • Development and execution of Post-marketing clinical plan
  • Planning and execution of clinical trials according to GCP and following company SOPs including
  • Contract negotiation with site
  • Maintaining and improving relationships with physicians/investigators
  • Preparation of trial related documentation
  • Organizing Ethics committee submissions
  • Performing study initiation’s visits, site monitoring and training
  • Data collection, analysis and reporting
  • Collaborating with physicians towards publication of study results
  • Scientific and strategic evaluation of ISTs, request from grants, etc
  • Lead the clinical knowledge in a specified field (platform) thus providing clinical evidence, training and support to Lumenis members and sites
  • Responsible for Medical Information responses concerning the specific platform for internal as well as external customers
  • Active participation in scientific meetings / lectures / congresses
  • Support Business Units activities from the scientific/medical point of view in strategic thinking, planning and execution
  • Support vigilance report review with professional, clinical knowledge
  • Budget management
58

Clinical Research Manager Resume Examples & Samples

  • Manage clinical study personnel focused on conducting clinical programs consistent with applicable regulations, guidelines, and policies. Interprets and executes on policies and procedures appropriate to clinical programs under his/her management. Recommends modifications to policies and procedures to larger clinical organization as necessary
  • Accomplishes results through experienced clinical research employees who exercise significant latitude and independence in their assignments
  • Provides ongoing training, direction and guidance on all clinical programs under their supervision
  • Conduct quarterly performance reviews and continuous employee development
  • Provide leadership and program representation with internal partners and external customers
  • Supervise training of study personnel including internal staff and external study sites (e.g. Principal Investigators, Study Site Support Staff, etc.)
  • Functions as an advisor to the Clinical Department Leadership regarding study strategy, projects, individual tasks and overall study operations
  • Ensures projects/programs are completed on schedule and within budget. Will drive highest quality program execution. Continually assess best practices and implement continuous improvement across studies as well as provide input to global department program execution
  • Participate on key functional workgroups to drive clinical wide or cross-departmental initiatives
  • Provide significant input and oversight to clinical program budgets
  • Ensures appropriate resources are maintained to effectively conduct clinical programs
  • Gives direction to staff on program priorities for various projects assigned to their area
  • Proactively engages senior clinical management in program risk discussions and provides well thought out solutions to issues
  • Identifies opportunities to strengthen clinical program quality and efficiency by assessing resource needs and capacities to ensure business objectives are met
59

Clinical Research Manager Resume Examples & Samples

  • Oversees the direction, planning, execution and interpretation of clinical research projects consistent with all applicable regulations, guidelines and policies
  • Accomplishes results through managing Senior Clinical Research Associates
  • Provides leadership in areas of technical mentoring and clinical trial planning
  • Insure adequate training for employees; develops employees and evaluates their performance; contributes input to the hire, termination and promotion of employees
  • Insures projects are completed on schedule and within budget
  • Able to refer to Standard Operating Procedures (SOPs) and Department Operating Procedures (DOPs) for guidance on everyday study tasks
  • Develops clinical plans, guidelines and strategies in consultation with clinical team, cross-functional project team, and investigators
  • Interfaces with regulatory agencies and/or payers including pre-IDE meetings w/FDA and prepares and conducts presentations to FDA panel reviewers re: requirements and results of study
  • Facilitates or conducts meetings in area of expertise with internal clients and physician customers
  • Reviews, approves and implements CAPA findings and Audit Report with Quality Department
  • Authors/co-authors results of studies in the medical literature and/or presents at scientific meetings
  • Assists in preparation and approves Clinical Reports, PMA submission Package
  • Provides input and support for planning post-clinical educational activities and market launch of products
  • Regularly communicates with Senior Management on resource requirements and staff performance
  • May be assigned as a clinical team member of a project core team
  • Resolves complex issues with input from team members and cross functional teams
  • Frequent interactions with peers, clients, vendors on significant matters
  • Interfaces with representatives from key functional groups to drive clinical wide or cross departmental initiatives
  • Represents organization as a prime internal and external contact on specific projects
  • Drives completion of projects and departmental initiatives and processes
  • Provide input and support for post-clinical activities and market launch of products
  • May support global activity
  • Participate in training to enhance knowledge base and may attend relevant scientific and or medical meetings
  • Minimum 8 years experience directly supporting clinical research
  • Management experience with the ability to delegate study workloads to best meet departmental goals
  • Cost-center/budget management experience
  • International clinical and/or regulatory experience preferred
  • Extensive knowledge of GCP and regulatory compliance guidelines and regulations for clinical trials
  • Advanced written, oral and interpersonal communication skills, including proficient knowledge of medical and regulatory terminology
  • Intermediate knowledge of word processing, spreadsheet, database and graphics presentation applications, and electronic meeting/calendar coordination
  • Experience leading complex projects and project teams
  • Experience in resource and expense management
  • Ability to drive process excellence and compliance with product/service quality standards
  • Demonstrated ability to identify and adapt to shifting priorities and competing demands
60

Clinical Research Manager Resume Examples & Samples

  • Supervise and provide oversight and guidance as needed to research staff; Supervise activities of subordinates as assigned
  • Strong organizational skills and significant attention to detail for data entry
  • Self-motivated, willing and able to take initiative
  • Ability to work both independently and with a team to resolve issues with a positive outcome
61

Clinical Research Manager Resume Examples & Samples

  • Provides leadership in developing study-related documents (e.g., budgets, data collection tools, investigator files and informed consent documents)
  • Reviews invoices from investigative sites, study vendors, and institutional review boards (IRBs) he/she is assigned to
  • Participates in negotiating clinical study agreements and will review and approve monitoring reports and invoices
  • Participates in the analysis, summary and reporting of clinical data
  • Will task manage Clinical Research Coordinators that are assigned to their studies (the CRM will not have any direct reports) or act as their own Clinical Research Coordinator on smaller trials assigned to
  • Maintains good relations with investigators and sponsors, including physicians, medical research staff and outside consultants
  • Serves as liaison between investigative sites and the clinical research organization (CRO), if appropriate
  • Ensures appropriate resources are available for assigned studies and resolves conflicts and issues
  • Able to perform monitoring visits (SQVs, SIVs, IMVs, COVs)
  • As needed, the CRM will identify and work with outside vendors to coordinate acquisition of materials and equipment needed for clinical studies/trials
  • Acts as the main line of communication between the Sponsor and the investigator and maintains contact with internal cross-functional departments
  • Maintains good relationships with investigators and their staffs, including physicians, medical research staff, and outside consultants
  • Performs Research coordination, planning and logistics, including oversight of budget and timelines
  • Responsible for the safety and proper conduct throughout the trial
  • Verifies that the investigator follows the approved protocol and all GCP guidelines
  • Verifies that source data/documents and other trial records are accurate, complete, and maintained
  • Ensures adverse events, concomitant medications, and intercurrent illnesses are reported on appropriate CRFs in accordance with the protocol
  • Ensures all CRFs are reviewed in a timely fashion and submitted to the data management group
  • Communicates deviations from the protocol, SOPs, GCPs, and the applicable regulatory requirements to the investigator
  • Develops study-related documents (e.g., case report forms, investigator files and informed consent documents)
  • Reviews invoices from investigative sites, study vendors, and institutional review board (IRBs)
  • Participates in clinical study agreement negotiations and reviewing and approving monitoring reports on assigned studies
  • Helps to review clinical study reports
  • Resolves research conflicts and issues
62

Clinical Research Manager Resume Examples & Samples

  • Bachelor’s degree or higher in a biomedical-related degree or related scientific field, including nursing qualifications; or a bachelors degree and 5 years of clinical study/trial experience including experience as a Clinical Research Associate (monitor)
  • Medical device experience is strongly preferred
  • Has knowledge of ICH-GCP requirements and a strong interest in clinical research
63

Clinical Research Manager Resume Examples & Samples

  • Support the local/regional planning and execution of Celgene-sponsored clinical trials (phases I-IV)
  • Have a comprehensive overview of all Celgene sponsored clinical study activities in the country / region
  • Support the feasibility process for clinical programs and studies in collaboration with Clinical Operations and CRO partners, as appropriate
  • Proactively collaborate with CROs, and Study Teams for the execution of clinical trials
  • Coordinate, plan, attend and participate/present at local investigator meetings as appropriate
  • Collaborate with local Medical Affairs to ensure clinical support and regional activities are in alignment with corporate objectives, as appropriate
  • Keep informed on relevant local regulations and law and communicate to applicable personnel, as appropriate
  • Scientific / healthcare related degree, preferred
  • Extensive experience in the (international) pharmaceutical / medical field with solid clinical trial management / monitoring experience, mandatory
  • Any relevant therapeutic area experience will be considered. Haemartology / Oncology experience is desirable
  • Line-management experience desirable
  • Excellent written and verbal communication and interpersonal skills. Must be able to relate effectively to people at all levels of the organization
  • Working knowledge of SOPs/regulations relevant to clinical research
  • Computer literate; familiarity with Microsoft Office programs, in particular, Word and Excel
64

Clinical Research Manager Resume Examples & Samples

  • Line management of Clinical Research Associates (CRAs)
  • Recruitment, initial and continued training and development of CRAs
  • Oversight and Management of CRAs to ensure CRAs are meeting expectations of core monitoring responsibilities
  • Tracking and management of CRA resourcing/allocation of assignment; and
  • Manage turnover and retention of CRAs to meet company objectives
  • Bachelor’s degree with 4-6 years pharmaceutical industry experience (clinical monitoring or study management), including 3 years as a CRA, and 1-2 years as a CRA Manager preferred
  • Advanced knowledge of Good Clinical Practice
  • Strong leadership, mentoring, and motivational skills
  • Proficient knowledge of Microsoft® Office software; and
  • Occasional travel for evaluation of CRAs (approximately 10%); and
  • This position is office based in Cincinnati, OH
65

Clinical Research Manager Resume Examples & Samples

  • Execute and oversee clinical trial country submissions and approvals for assigned protocols
  • Develop materials including local language Informed Consents and translations
  • Work in partnership with IRB/IEC and Regulatory Authority on submission and approval-related interactions for assigned protocols
  • Manage country deliverables, timelines and results for assigned protocols to meet country commitments
  • Responsible for quality and compliance in assigned protocols in the country
  • Contribute to the development of local SOPs, may oversee contract workers (CTCs) and local vendors as applicable
  • Collaborate internally with GCTO country operations (CRM, CTC,CRA), CQM, Finance, Medical Affairs, Regulatory Affairs, PV, Business Compliance, Legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones
  • Responsible for clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management