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Clinical Research Project Coordinator
3 semanas atrás
The Clinical Research Manager is accountable for managing and executing clinical trials in compliance with regulatory standards. They oversee all aspects of assigned projects, including study planning, coordination, and execution.
Key Responsibilities- Develops strategic plans for country-specific clinical trial initiatives.
- Collaborates with cross-functional teams to ensure timely completion of clinical deliverables according to country commitments.
- Ensures close collaboration with local regulatory authorities, ethics committees, and site staff to facilitate smooth clinical trial execution.
- Coordinates preparation and submission of clinical trial documentation to regulatory authorities and ethics committees as required.
- Monitors and reports on clinical trial progress, identifying and escalating any deviations or issues that may impact trial timelines or quality.
- Minimum 5 years' experience in clinical operations with a focus on project management and/or monitoring of clinical trials.
- Proven ability to lead in a matrix environment without direct reports.
- Understanding of all aspects of clinical drug development with particular emphasis on trial set-up, execution, and monitoring.
Preferred Qualifications:
- Master's degree in a related field such as life sciences, business administration, or public health.
- Professional certifications such as CCRA, CRA, or PMP.