The Clinical Operations Manager oversees clinical trials, ensuring compliance with regulations while managing budgets, timelines, and team coordination.
About the Role
We are seeking a detail-oriented and results-driven Clinical Operations Manager to oversee and optimize clinical trial activities. This role is responsible for ensuring studies are conducted in compliance with regulatory requirements, company SOPs, and Good Clinical Practice (GCP) guidelines while meeting timelines and budget expectations.
Key Responsibilities
- Oversee planning, execution, and closeout of clinical trials.
- Manage study timelines, budgets, and deliverables.
- Coordinate with cross-functional teams including Regulatory, Data Management, and Medical Affairs.
- Ensure compliance with GCP, ICH guidelines, and applicable regulations.
- Select and manage CROs, vendors, and clinical sites.
- Monitor site performance and resolve operational issues.
- Review clinical documents (protocols, CRFs, monitoring reports).
- Support audit readiness and inspection activities.
- Track and report study progress to leadership.
Top Skills
Good Clinical Practice
Ich Guidelines
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