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 Clinical Operations Lead 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, oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions. The Clinical Operations Lead will develop study tools for sites and CRA use, review visit reports, review and track protocol deviations, and support other objectives for clinical operations and the clinical project team.
Germany, Romania, UK, Canada, Netherlands, USRead More