Clinical Project Manager Job Description
Clinical project manager
provides interpretation and guidance for internal and external customers on clinical quality related regulations / guidelines (FDA, ICH, EU, etc.) and company procedures and policies, proactively maintaining cognizance of current GCP standards.
Clinical Project Manager Duties & Responsibilities
To write an effective clinical project manager job description, begin by listing detailed duties, responsibilities and expectations. We have included clinical project manager job description templates that you can modify and use.
Sample responsibilities for this position include:
Oversee the progress of the clinical trial and ensure that the trial is conducted, recorded and reported in accordance with the protocol, standard operating procedures (SOPs), GCP and applicable regulatory requirements
Develop and manage study timelines and budgets utilizing MS Project
Calculate drug supply needs, liaise with Tech Ops
Plan Investigator Meetings
Gather site information from Site Manager to have an understanding of each site in the study
Create strategy for patient recruitment and retention
Report to Associate Director of Clinical Operations
Manage and develop the project team
Supervise and evaluate assigned project staff activities and job performance
Provide continuous support of monitoring responsibilities
Clinical Project Manager Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Clinical Project Manager
List any licenses or certifications required by the position: PMP, CCRA, PMI, GCP, IATA, LEAN, MS, ACRP, HEDIS, NCQA
Education for Clinical Project Manager
Typically a job would require a certain level of education.
Employers hiring for the clinical project manager job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Life Sciences, Nursing, Healthcare, Education, Pharmacy, Medical, Science, Health Care, Project Management, Life Science
Skills for Clinical Project Manager
Desired skills for clinical project manager include:
FDA regulations
Current ICH GCP guidelines
Clinical research process from Phase I through regulatory submission
GCP
ICH guidelines
Excel
Word
PowerPoint
GCP and ICH Guidelines for clinical research
Therapeutic area
Desired experience for clinical project manager includes:
Act as principle liaison between sponsor, CRO and investigator sites
Negotiate budgets and monitor investigator payments
Assess & pronounce on clinical sites & staff's suitability to conduct the protocol
Track & manage study contracts to provide timely and accurate input into financial management systems and so delivering study to agreed budget
Determines the preliminary design of the study and evaluates and understands the study
Initiates the involvement of appropriate departments, maintaining continuous communication with those departments, and ensures the work delivered to customers is of a consistently high standard
Clinical Project Manager Examples
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Clinical Project Manager Job Description
Job Description Example
Our growing company is looking to fill the role of clinical project manager. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for clinical project manager
- Contribute to the study and/or site budget development, protocol outline development
- Oversee the site feasibility and qualification process for identification of qualified investigational sites per protocol requirements
- Serve as the liaison and/or Subject Matter Expert when defining the scope for vendor and/or site contracts
- Track & manage study contracts per their defined scope and budget
- Prepare, review & quality control essential study documents and collate all in Trial Master File or confirm that CRO provides adequate TMF documentation
- Creates and executes IS project work plans and revises as appropriate to meet changing needs and requirements
- Ability to understand technical requirements of projects and effectively manage resources, vendors and test effort action plans, impact and resolution options
- Good understanding of healthcare practices and clinical related applications, including EMR and laboratory applications
- Manages day-to-day operational aspects of a project and scope along with identifying resources needed and assigning individual responsibilities
- Reviews deliverables prepared by team before passing to customer
Qualifications for clinical project manager
- Bachelor's degree required and 5 years of related clinical experience or the equivalent combination of education and experience is required
- Must have knowledge of Database software
- Evidence of building relationships with and managing expectations of stakeholders at all levels and externally, to persuade on business benefits and gain acceptance to changes
- Must be able to displays original thinking and creativity
- Effective written, verbal, presentation and communication skills in the area of technical/clinical applications
- Review the clinical study protocol and supporting documents– Statistical Analysis Plan, CRFs, Data Management Plan, Clinical Study Report, monitoring plan, communication plan, timeline, to ensure seamless integration between clinical objectives and study performanc
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Clinical Project Manager Job Description
Job Description Example
Our company is looking to fill the role of clinical project manager. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for clinical project manager
- Experience working with and coordinating teams that are geographically disperse
- Knowledge of HL7 and interface methodologies
- Experience in .NET, Java and related internet technologies (REST, Web Services, ..) is an asset
- Ensures a common understanding of project goals by setting and managing expectations
- Facilitates change management, focuses on process integration/analysis and measurements for success
- Assembles and manages the project team, identifies appropriate resources needed, and develops a schedule to ensure timely completion of projects focusing on targeted outcomes
- Quantifies and articulates desired outcomes and measurements
- Analyzes impact on business processes and handoffs between departments/functions
- Establishes priorities which meet the project goals and objectives, and identify areas of improvement
- Provides and maintains all detailed project documentation including but not limited to project definition, roadmaps, project plans and testing plans
Qualifications for clinical project manager
- Bachelor's degree in life sciences or equivalent combination of education, training and experience
- Minimum of 5 years clinical research experience including 2 years project management experience
- Possess a working understanding of medical and clinical research terminology
- A minimum of 10 years of clinical or research industry or relevant work experience including a minimum of 4 years project management experience
- Previous line management experience preferred but not essential
- University degree (equivalent of Bachelors Degree in the US)
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Clinical Project Manager Job Description
Job Description Example
Our growing company is looking to fill the role of clinical project manager. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for clinical project manager
- Develops clinical research protocols
- Interface with clinical data management and statistics in developing case report forms, managing data cleanup, and analyzing study data
- Develops project budget/schedule in collaboration with Core Team and/or Program Management
- Trains and oversees monitoring teams (CRAs) and the timeliness and quality of their work
- Oversees study vendors (reference labs, CRO, other potential vendors)
- Maintains trial master file and all relevant trial documentation
- Performs study execution and status reporting activities
- Prepares final clinical study report and oversee study closeout activities
- Leads study teams for studies of moderate to high complexity
- Contributes to department/function continuous improvement activities/initiatives
Qualifications for clinical project manager
- BSc or MSc in biological science or other relevant science
- Experience of managing multi-site, international clinical studies and coordinating activities of cross-functional operational teams and communication with internal & external trial stakeholders
- Medical qualifications, bachelor degree or above in Clinical Medicine, Pharmacology and Public Health, , strong emphasis in science
- Robust demonstrable clinical research experience in a bio-pharmaceutical company/CRO including demonstrated skills and competency in project management tasks
- Minimum of four (4) years of relevant clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits)
- In lieu of the above requirements, candidates with five (5) years of site management and/or study/project coordinator experience will be considered
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Clinical Project Manager Job Description
Job Description Example
Our company is growing rapidly and is looking to fill the role of clinical project manager. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for clinical project manager
- Coordinates the review and acceptance of vendor deliverables and approves vendor invoices for payment
- Educate self and others about the clinical outsourcing capabilities of CMOs and core operational issues at CMO sites
- Identify and implement improvements within BMS and at CMOs
- Develop self and others as appropriate
- Lead and manage a multidisciplinary cross functional Clinical Trial Team (CTT) (medical writing, statistics, data management, monitoring partner, drug supply, regulatory, safety ) or support the Sr
- Lead and manage a multidisciplinary cross functional Clinical Trial Team (CTT) (medical writing, statistics, data management, monitoring partner, drug supply, regulatory, safety ) to ensure study deliverables are met according to time-lines, budget, quality standards and operational procedures
- Accountable for the writing or contributing to the development of Clinical Study Protocol, amendments, Informed Consent Form and other study essential documents, and contributing to clinical sections of regulatory documents (Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions, review of clinical trial application packages) as required
- Accountable for the development, management and tracking of study budget (internal and external costs) working closely with the PLS Finance and customer representative
- Manages clinical outsourcing to CROs and other vendors such as IRT, central and specialty labs
- Responsible for the clinical review and/or approval of CRFs, completion guidelines and the data review plan
Qualifications for clinical project manager
- 5+ years of relevant hands-on experience in a Clinical Project Manager role
- Oncology experience Phase I or II
- Thorough understanding of cross-functional clinical processes including data management
- Biostatistics, medical writing, drug safety, and regulatory affairs
- Strong leadership, communication, management and organizational skills, conflict resolution, and
- Ability and willingness to trave1 25% of the time (internationally and domestically)
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Clinical Project Manager Job Description
Job Description Example
Our company is hiring for a clinical project manager. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for clinical project manager
- Oversee all aspects of trial conduct from Study start-up through close-out
- Develop plans to achieve contracted milestones
- Monitor project progress against the established plans and ensure compliance with plans
- Manage project budget and resource expenditures including invoicing, analyzing cost variances and conducting revenue recognition
- Supervise assigned project team members including Clinical Research Associates, Clinical Site Specialists, Regulatory Associates, Project Associates
- Provide operational input and participate in the design and review of study protocols, case report forms (CRFs), associated study documents and plans, monitoring plans, and regulatory submissions and reports in collaboration with project team
- Coordinate development of patient/subject consent forms and site/patient materials
- Prepare and participate in presentations to clients in Defence of proposals
- Provide input into client proposals in response to Requests for Proposals (RFPs)
- Serves as key management and primary contact for customer(s)
Qualifications for clinical project manager
- Familiarity with financial budgeting or reporting
- Bachelor's Degree in Engineering, Technology or related from a four-year college or university
- Project management including portfolio management (Clinical Application)
- Managing large scale teams
- Quantification of outcomes and measurements
- Project Management Certification or equivalent, Six Sigma, Lean or related certification