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Clinical Research Operations Manager
2 months ago
Position Overview:
A dynamic biopharmaceutical organization is seeking to enhance its Clinical Operations team by adding two Clinical Trial Managers. This role is pivotal in supporting the Head of Clinical Operations and will involve overseeing the recruitment, initiation, execution, and closure of clinical trials. Additionally, the Clinical Trial Manager will assist in managing the daily operations of the Clinical Research Associate (CRA) field staff.
Key Responsibilities:
- Coordinate and monitor visits for the clinical monitoring team.
- Track and manage project-specific training for field CRA personnel.
- Review and finalize monitoring visit reports and follow-up communications.
- Oversee trial start-up activities and manage regulatory documentation to ensure site readiness.
- Administer the electronic Trial Master File (eTMF).
- Manage clinical supplies in collaboration with the unblinded CRA.
- Develop and implement study-specific plans and monitoring tools.
- Ensure compliance with standard operating procedures (SOPs), local regulations, and industry guidelines.
- Participate in the creation of data collection forms and database entry screens.
- Support the development of Institutional Review Board (IRB) submission packages.
- Conduct field monitoring and co-monitoring as required.
- Engage in site qualification, initiation, interim monitoring, and close-out visits as necessary.
- Evaluate field monitors at scheduled intervals.
- Oversee study progress and daily operations with site personnel.
Qualifications:
- Registered Nurse (RN), Radiologic Technologist (RT), or a bachelor’s degree in a science-related discipline or equivalent experience.
- Minimum of 5 years in the clinical trials sector or a related field, with over 8 years of industry experience preferred.
- Experience in clinical roles (RN, PA, etc.) with CRA exposure is advantageous for understanding field operations and medical terminology.
- Demonstrated experience in supporting Phase 2B and Phase 3 studies, with a focus on launch activities.
- Prior work experience with both sponsors and Contract Research Organizations (CROs).
- Experience with blinded and unblinded Phase 2 and 3 studies, with a primary focus on blinded studies.
- Familiarity with therapeutic areas such as neonatal care, respiratory, intensive care, and oncology, with significant study involvement.
- Proficient in using various Electronic Data Capture (EDC) platforms.
- Willingness to travel up to 25% for both domestic and international assignments.
- Able to work onsite as required, with a preference for specific locations.
- Preferred Skills: Experience in clinical supply chain management, particularly with complex drug and device logistics.
- Background in a startup environment is a plus.