
Senior Clinical Research Manager
7 hours ago
Job Summary:
The Clinical Research Leader will oversee clinical trials and research studies, ensuring timely completion and regulatory compliance.
- Clinical Trial Management:
- Plan, initiate, and execute clinical research projects from inception to completion.
- Coordinate and manage the execution of clinical trials, adhering to protocols and timelines.
- Ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and ethical standards.
- Team Leadership:
- Lead and mentor clinical research staff, ensuring they are trained and performing effectively.
- Assign tasks and responsibilities to team members based on project needs.
- Regulatory Compliance:
- Oversee the preparation and submission of regulatory documentation, including Institutional Review Board (IRB) applications.
- Monitor compliance with federal, state, and local regulations.
- Study Design & Protocol Development:
- Collaborate with scientific and medical teams to develop clinical trial protocols.
- Evaluate feasibility and risk of proposed studies.
- Data Management and Reporting:
- Ensure efficient and accurate data collection, monitoring, and analysis.
- Review and analyze clinical trial data to ensure quality and integrity.
- Budget and Resource Management:
- Develop and manage project budgets, ensuring timely completion within financial constraints.
- Oversee resource allocation, including personnel, equipment, and materials.
- Collaboration and Communication:
- Foster communication between internal teams and external partners.
- Collaborate with clinical research coordinators, data managers, and other departments to ensure effective study execution.
- Continuous Improvement:
- Identify areas for process improvement in clinical trial execution and management.
- Implement best practices to optimize research efficiency and compliance.
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