
Clinical Research Director
2 weeks ago
This is a highly specialized role that requires exceptional leadership and management skills to oversee the planning, execution, and management of clinical trials and research studies. The successful candidate will have strong project management, leadership, organizational skills, excellent communication and interpersonal skills.
Key Responsibilities:- Clinical Trial Management:
- Develop and implement clinical research projects from initiation to completion
- Coordinate and oversee trial execution, ensuring adherence to protocols, timelines, and budgets
- Ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and ethical standards
- Provide oversight on subject recruitment, enrolment, and monitoring
- Build and maintain relationships with CROs, investigators, and external vendors
- 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
- Develop training programs and provide ongoing professional development for research teams
- Regulatory Compliance:
- Oversee regulatory documentation preparation and submission, including IRB applications and clinical trial applications
- Monitor compliance with federal, state, and local regulations, as well as company policies
- Ensure timely adverse event reporting and study ethics
- 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 data collection, monitoring, and analysis are conducted efficiently and accurately
- Analyze clinical trial data to ensure quality and integrity
- Prepare and present progress reports to senior leadership and stakeholders
- Budget and Resource Management:
- Manage project budgets, ensuring timely completion within financial constraints
- Oversee resource allocation, including personnel, equipment, and materials
- Collaboration and Communication:
- Foster effective communication between internal teams, external partners, and key stakeholders
- Collaborate with clinical research coordinators, data managers, and other departments
- Resolve issues related to clinical trial execution and provide solutions
- Continuous Improvement:
- Identify areas for process improvement in clinical trial execution and management
- Implement best practices to optimize research efficiency and compliance
Education: Bachelor's degree in Life Sciences, Clinical Research, or a related field (Master's or higher preferred)
Experience: 8-18 years of experience in clinical research, with at least 2-3 years in a managerial or supervisory role
Skills: Strong project management, leadership, organizational skills, excellent communication and interpersonal skills
Certifications: Clinical Research Coordinator (CRC) or Clinical Research Associate (CRA) certification preferred
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