The Clinical Project Manager is responsible for project management for clinical trials. Specific responsibilities include the following:
- Manage all aspects of assigned clinical trials in accordance with FDA, GCP, and ICH guidelines. Create and oversee project timelines and budgets.
- Contribute to the creation and review of essential trial documents such as protocols, informed consents, case report forms, and study manuals.
- Evaluate, select, negotiate, contract and manage service providers (e.g. CROs, lab vendors). Develop and execute quality management plan.
- Maintain trial level tracking, including enrollment, trial status, and SAE reporting.
- Ensure trial delivery on time, on budget and with appropriate quality. Identify potential risks to budget and timeline.
- Establish relationships with site personnel; lead investigator calls.
- Manage study supplies and study drug ordering.
- Oversee maintenance of the trial master file.
- Review clinical data; work with programming team and medical on publications.
- Travel to sites to oversee CRAs and assist sites with trial execution.
- Coordinate with finance department for site payments.
- Create SOPs and templates as needed.
Education and Experience
- Bachelor degree ; BS in health related field preferred
- Minimum of 5 years experience in clinical research in CRO, pharmaceutical or biotechnology environment
- Forecasting and budgeting experience
- Deep knowledge of regulatory guidelines including ICH/GCP
- Strong attention to details and solid follow through.
- Strong communication and organizational skills
- Strong technology skills (e.g. Microsoft Excel, Word, Project, PowerPoint)
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