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Director, Clinical Operations
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Full-time
- This will generally involve close supervision of external contract organizations who will have responsibility for site interaction, site monitoring, data management, biostatistics, IRB interaction, central laboratory function, clinical research budget negotiation, medical writing, pharmacovigilance, and other critical activities.
- Establishes and maintains good working relationships with clinical study site personnel to ensure adherence to protocols and Good Clinical Practice (GCP), provision of quality data and adherence to study timelines.
- Maintains oversight of the conduct of the studies at the study centers (site selection, start up, monitor adherence to protocols and Good Clinical Practices (GCP), applicable guidance and study closure)
- Interfaces with Chief Medical Officer/Medical Monitor and cross-functional team members including Data Management, Drug Safety, Logistics/Manufacturing, Project Management, Regulatory Affairs, and Biostatistics
- Serve as company representative at external meetings, scientific congresses, etc.
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