• Lead or support study operational strategy and planning and oversee execution of select clinical studies for assigned clinical program(s). • Oversee Strategic Partners and/or other CROs and other vendors to meet obligations described in ICH-GCP and business objectives. • Accountable for planning and operational strategy and execution for assigned clinical trials. • Provides subject matter expertise and operational input into protocol synopsis, final protocol and other study related documents. • Challenges study team to ensure operational feasibility, inclusive of patient and site burden. • Supports budget development and ensures impacts are adequately addressed. • Works closely with COM (if applicable) and COPL, Global Program Management, and Finance to ensure on a regular basis that budgets, enrollment, and gaiting are accurate. • Communicates study status, cost and issues to COM and COPL; serve as escalation point for all vendors managed by Strategic Partner and/or other CROs. • Ensures new team members and vendors are appropriately onboarded.