Clinical Operations Lead (Clinical Trial Manager)
Required skills
Oversight of project deliverables, assigned Clinical Research Associates (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations. Acts as a primary liaison between CRAs and the clinical project team. Project specific training of CRAs, conducting assessment visits with CRAs, implementation of enrollment and recruitment strategies, preparation of the monitoring plan and other structural documentation. Oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions. Develop study tools for site and CRA use, review visit reports, review and track protocol deviations.
Preferred skills
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Technologies
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Responsibilities
Overall oversight of regional CRAs to ensure site compliance with study protocol, study plans, ICH-GCP, local regulations and study timelines. Monitoring support visits (Co-monitoring) per project requirements. Support clinical project team by providing oversight of study deliverables related to other departments. Oversee regional startup and feasibility activities. Assist in vendor management activities. Perform review of visit reports for quality, compliance and appropriate site management. Assure compliance with high quality and timely project deliverables. Proactive management of site and country performance. Contribute to financial project management processes. Conduct regular global CRA calls with the monitoring and site management team. Attend meetings with Study Sponsor. Provide operational support and guidance to the monitoring team. Provide project training/mentoring to regional CRAs. First point of contact for regional CRAs for study-specific questions and issues. Support line managers by providing status updates on utilization.
Seniority
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Domain
Clinical trials, pharmaceuticals, healthcare