
Principal Research Operations Manager
4 days ago
The Senior Clinical Research Manager will lead and manage clinical trials and research studies, ensuring that they are completed on time, within budget, and in compliance with regulatory standards.
Clinical Trial Management:
- Clinical Trial Planning: Plan and initiate clinical research projects from start to finish. Coordinate and oversee the execution of clinical trials, ensuring adherence to protocols, timelines, and budgets.
- 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 and clinical trial applications.
- Study Design & Protocol Development: Work with scientific and medical teams to develop clinical trial protocols. Ensure protocols meet study objectives, regulatory standards, and ethical guidelines.
- Data Management and Reporting: Ensure data collection, monitoring, and analysis are conducted efficiently and accurately. Review and analyze clinical trial data to ensure quality and integrity.
- Budget and Resource Management: Develop and manage project budgets, ensuring that clinical trials are completed within financial constraints. Oversee resource allocation, including personnel, equipment, and materials.
Required Skills and Qualifications:
- Education: Bachelor's degree in Life Sciences, Clinical Research, or a related field (Master's or higher preferred).
- Experience: 8 to 18 years of Experience in clinical research, with at least 2-3 years in a managerial or supervisory role.
- Skills: Strong project management, leadership, and organizational skills. Excellent communication and interpersonal skills, with the ability to interact effectively with internal and external stakeholders.
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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