Job Summary:
The Clinical Research Manager oversees the planning, coordination, and execution of clinical trials and research studies. This role involves ensuring compliance with regulatory guidelines, managing research teams, and collaborating with healthcare professionals and sponsors. The Clinical Research Manager is responsible for maintaining quality control, monitoring trial progress, and ensuring that studies are completed on time and within budget.
Key Responsibilities:
- Oversee the day-to-day operations of clinical trials and research studies.
- Ensure compliance with regulatory standards (e.g., FDA, ICH-GCP) and institutional policies.
- Coordinate with investigators, sponsors, and research staff to ensure efficient trial execution.
- Manage study timelines, budgets, and resources.
- Monitor trial progress and resolve issues to ensure timely completion.
- Prepare and review study protocols, consent forms, and other documentation.
- Ensure proper data collection, management, and reporting.
- Train and supervise clinical research staff.
- Maintain communication with stakeholders, including sponsors, regulatory bodies, and patients.