- Provide operational leadership for the planning, start-up, conduct, maintenance, and close-out of assigned global studies or regions.
- Serve as the principal Clinical Operations representative on cross-functional study teams.
- Develop, review, and maintain integrated study execution plans, enrollment plans, oversight plans, and operational trackers.
- Contribute operational input to protocols, informed consent forms, eCRFs, and clinical study reports.
- Lead or oversee country and site feasibility, site selection, activation, training, enrollment, and close-out activities.
- Manage CRO and vendor selection, performance, governance, and invoice reconciliation.
- Monitor study performance through KPIs and risk management plans.
- Ensure sponsor oversight activities are documented and inspection-ready including eTMF management.
- Provide technical guidance, coaching, and mentoring to junior team members.
Budget management