Clinical Research Project Manager II,
Durham, United States
FHI 360
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Job Summary / Responsibilities
- Responsible for the overall coordination and management of clinical projects/studies from start-up through close-out activities. The CRPM II is responsible for the management of complex, multicenter, multinational clinical studies, including FDA-regulated clinical trials.
- Directs the technical and operational aspects of clinical research efforts, including providing supervisory and mentoring support to other clinical research staff, to ensure the successful completion of clinical studies.
- Manages complex relationships with a diverse group of collaborators representing donor agencies, local government, non-government organizations, industry, and academia. Works with major functional area leads to identify and evaluate fundamental issues on the project, makes sound business decisions and ensures solutions are appropriately vetted and implemented.
- Works to ensure all project deliverables meet the sponsor's time/quality/cost expectations.
- Works in collaboration with other functional area leads providing accurate labor forecasts, reviewing pass-through costs and ensuring timely invoicing.
- Effectively creates operational project plans tailored to the particular needs of each assigned study. Collaborates with centralized, remote monitoring units to ensure project progress and deliverables meet or exceed contractual requirements. Ensures that all clinical study management and project deliverables are completed to the sponsor's satisfaction, ensuring quality deliverables on time and within budget and in accordance with Standard Operating Procedures (SOPs), policies and practices.