The Clinical Project Manager is responsible for the overall management and coordination of operational activities involved in the planning, conduct and completion of clinical trials including the management of deliverables, adherence to budget, and ongoing risk mitigation. The PM manages CROs and leads cross functional project teams (clinical monitoring, data management, biostatistics, medical writing, medical affairs, regulatory affairs, and clinical QA) to ensure the project is completed on time, within budget, and with high quality.
- Drive the planning, formation and execution of timelines for assigned clinical trial
- Assist the clinical development staff in developing and reviewing protocols, investigator brochures, informed consent forms, clinical study reports and other scientific documents
- Identify, evaluate, and select external vendors (central lab, CROs, consultants/contractors)
- Develop contracts for and perform ongoing management of vendors to ensure deliverables and performance adhere to contract
- Oversee the development of plans and execution of those plans related to site monitoring, safety management, data management and biostatistics
- Oversee the identification, selection and proper initiation of sites
- Oversee development of CRFs, clinical and safety databases, and shell Tables, Figures and Listings
- Plan, coordinate and conduct investigator meetings
- Execute and control project activities, including scope, schedule, budget and risk associated with each assigned project. Report performance to senior management
- With Medical Affairs, assess trends in data including adverse events, protocol violations, etc.
- Oversee timely database freeze and database lock. Participate in data review meeting.
- Establish communication plans for information distribution to team members
- Identify and track key study metrics in order to identify/anticipate issues (early) and conduct root-cause investigations for issue resolution and/or escalation (as needed)
- Ensure adherence to SOPs, Good Clinical Practice and FDA/ICH regulations
- Bachelors degree in science preferred
- 5+ years of clinical project management experience in biotechnology or pharmaceutical company setting including study initiation, conduct and close-out and management of CROs