The Clinical Project Manager is responsible for project management expertise for clinical trials.
Create and oversee project timelines and budgets, manage competing timelines and prioritize critical tasks.
Contribute to the creation and review of essential trial documents such as protocols, informed consents, case report forms, clinical study materials and monitoring tools.
Ensure appropriate versioning and translations of documents.
Schedule and lead trial team meetings throughout the life of the trial.
Maintain trial level tracking, including enrollment, trial status, and SAE reporting.
Lead, support, and guide trial team members to ensure trial delivery on time, on budget and with appropriate quality. Track budget and timeline against plan.
Evaluate, select, negotiate, contract and manage service providers (e.g. CROs, consultants).
Planning and execution of trial level site relations, including site identification, selection, investigator meetings, and newsletters. Ensure proper paperwork is completed and filed for investigative sites to participate in clinical trials.
Coordinate with finance department for site payments.
Work with other departments to ensure timelines are met and that all projects are performed in accordance with internal and external regulatory and compliance processes.
Conduct contingency planning, identify short and long-term project issues, and provide suggested solutions to management.
Create SOPs as needed.
Work effectively as a team player within Clinical.
Education and Experience
Bachelors degree in health related field
Minimum of 5 years experience in clinical research (Phases I through IV) in CRO, pharmaceutical or biotechnology environment
Sufficient knowledge of clinical trials process to allow best use of resources and planning
Proven experience in project management for clinical trial activities
Forecasting and budgeting experience
Strong attention to details and solid follow through.
Ability to complete deliverables on time and adjust priorities in a fast paced environment