Clinical Project Manager
about this position
Serve as the clinical point person leading the cross-functional project team meetings; responsible for generating meeting agendas and minutes.
Establish study milestones to be in alignment with company goals; ensure the project team is in alignment with study milestone dates; and track/report on study metrics and timelines.
Ensure the project team adheres to ICH/GCP/Federal and local regulations and company SOPs.
Identify, evaluate, select, and manage CROs and essential vendors.
Ensure oversight of set-up, training, and monitoring of sites participating in clinical trials.
Facilitate the development of clinical trial agreements and other relevant documents, in conjunction with Legal.
Participate in review of scope of work, budgets, vendor performance, and issue resolution.
Assist in preparation and review of clinical documents such as informed consent, clinical protocol, investigator brochure, monitoring plan, pharmacy manual, project plans, tracking tools, SIV materials, training presentations, and other study related documents as required.
Review of monitoring visit reports submitted by CRAs for assigned clinical trials.
Ensure the Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic reviews.
Work with Quality to proactively anticipate risks, and plan for and implement risk mitigation strategies throughout the conduct of the trial.
Participate and respond to Quality and/or regulatory authority inspection audits.
Participate in program strategy meetings and operations’ initiatives and programs.
Perform other related duties as required.
May be expected to mentor and develop junior clinical operations staff
- Master’s degree or equivalent
- Minimum of 5 years of experience in clinical research, with at least 2 years of experience in clinical trial management
- Experience in management of CROs, vendors, and consultants
- Excellent cross-functional clinical project management skills
- Excellent written and verbal communication skills
- Excellent working knowledge of FDA & ICH GCP regulations and guidelines in clinical trials
- Demonstrated ability to implement SOPs and Study Plans
- Demonstrated self-starter and team player with strong interpersonal skills
- Demonstrated problem solving abilities and strong organizational skills
- Strong computer skills, including MS Office and PowerPoint
- Position may require some travel
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