Clinical Operations Lead

Responsible for the clinical operations of a project within a defined regional/global level. Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations. The COL acts as a primary liaison between the CRAs and the clinical project team. Additional responsibilities include 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 and the oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions. The COL will develop study tools for site and CRA use, review visit reports, review and track protocol deviations, and support other objectives for clinical operations and the clinical project team. Project Oversight Overall oversight of (a group 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, to aid the site/CRA in the satisfactory performance and compliance with standards mentioned above. May support clinical project team by providing oversight of study deliverables related to other departments (e.g. Data Management, TMF Operations, etc.) Oversee regional startup and feasibility activities. Assist in vendor management activities as required per project. Perform review of visit reports for quality, compliance and appropriate site management. Assure compliance with high quality and timely project deliverables according to the project requirements and the monitoring plan. Proactive management of site and country performance (recruitment, data collection, document collection, TMF review etc.) and inform clinical project team on progress. Contribute to financial project management processes as applicable. May include but may not be limited to input on revenue recognition, site payments, and site pass-through expense review. May be required to manage/oversee investigator sites including CRA responsibilities, on a temporary or permanent basis. Project Liaison Conduct regular global CRA calls with the monitoring and site management team, as well as individual/country CRA calls Attend meetings with Study Sponsor to provide status updates on country and site progress Provide operational support and guidance to the monitoring team throughout project. Provide project training/mentoring to regional CRAs on study procedures, clinical plans and guidelines, and timelines for the study. Ensures study specific training requirements are completed and documented. First point of contact for regional CRAs for study-specific questions and issues. Escalates to PM and other functions as appropriate. Support line managers by providing status updates on utilization