Found Description
We are seeking an experienced Clinical Study Manager to lead the development and execution of complex clinical studies. This role is responsible for overseeing clinical strategies to evaluate product safety and effectiveness, driving study milestones, and ensuring compliance with regulatory standards and Good Clinical Practice (GCP).
Responsibilities
- Design, plan, and oversee clinical evaluation research studies from inception through completion
- Author protocols and patient record forms; interpret results of clinical investigations
- Manage operational aspects of trials in accordance with SOPs, GCP, and country-specific regulations
- Provide work direction to cross-functional teams including site managers, monitoring, safety, and statistics
- Serve as the primary liaison between study teams and leadership; manage budgets, schedules, and status reporting
- Collaborate with medical affairs, regulatory, and marketing ...