
Senior Clinical Research Director
13 hours ago
Job Overview:
This role is responsible for leading and managing clinical trials and research studies. Ensuring timely completion and compliance with regulatory standards are key objectives.
Main Responsibilities:
- Clinical Trial Management:
- Develop and execute strategic plans for clinical research projects from inception to closure.
- Coordinate and oversee the execution of clinical trials, ensuring adherence to protocols and timelines.
- Maintain Good Clinical Practice (GCP), regulatory requirements, and ethical standards.
- Team Leadership:
- Foster a high-performing team by providing guidance, training, and development opportunities.
- Assign tasks and responsibilities to team members based on project needs.
- Regulatory Compliance:
- Ensure accurate preparation and submission of regulatory documentation, including Institutional Review Board (IRB) applications.
- Monitor compliance with federal and local regulations, as well as company policies.
- Study Design & Protocol Development:
- Collaborate with scientific and medical teams to design and develop clinical trial protocols.
- Verify that protocols meet study objectives and regulatory standards.
- Data Management and Reporting:
- Guarantee efficient and accurate data collection, monitoring, and analysis.
- Review and analyze clinical trial data to ensure quality and integrity.
- Budget and Resource Management:
- Establish and manage project budgets, ensuring timely completion within financial constraints.
- Communication and Collaboration:
- Facilitate communication between internal teams, external partners, and key stakeholders.
- Process Improvement:
- Identify areas for process improvement in clinical trial execution and management.
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