Global Project Manager, FSP

Job Description: • 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. Requirements: • Bachelor’s Degree or international equivalent required; Life Sciences preferred. • Knowledge in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. • Demonstrated successful experience in project/program management and matrix leadership. • 5+ years’ experience in pharmaceutical industry and/or clinical research organization, including 3+ years clinical study management/oversight. • Experience could include either early phase clinical studies or Phase 2 and 3 studies and global/international studies or programs. • Experience in more than one therapeutic area is advantageous. • Fluent business English (oral and written). Benefits: • Health insurance • 401(k) matching • Flexible work hours • Paid time off • Professional development opportunities Apply tot his job Apply To this Job