Job Summary:
The Clinical Research Manager will oversee and manage clinical trials from initiation through completion, ensuring compliance with regulatory requirements and adherence to study protocols. This role involves coordinating with cross-functional teams, managing budgets and timelines, and ensuring high-quality data collection and reporting. The ideal candidate will have a strong background in clinical research, excellent organizational skills, and a proven ability to lead and mentor research teams.
Key Responsibilities:
- Project Management: Plan, execute, and oversee clinical research projects, including study design, protocol development, and site selection.
- Regulatory Compliance: Ensure all research activities comply with federal, state, and local regulations, as well as Good Clinical Practice (GCP) guidelines.
- Team Leadership: Supervise and mentor clinical research coordinators, clinical research associates, and other staff. Facilitate training and professional development.
- Budget & Resource Management: Develop and manage study budgets, including cost estimates, expenditures, and resource allocation.
- Site Coordination: Collaborate with clinical trial sites to ensure proper study conduct, patient recruitment, and data collection.
- Documentation: Maintain and review all study documentation, including regulatory submissions, informed consent forms, and study reports.
- Communication: Serve as the primary point of contact for study sponsors, investigators, and internal stakeholders. Facilitate regular project meetings and updates.
- Quality Assurance: Conduct regular monitoring visits and audits to ensure adherence to protocols and identify areas for improvement.
- Problem-Solving: Address and resolve any issues or deviations that arise during the course of the study, implementing corrective actions as needed.
