Senior Manager Global Study Start Up

Responsibilities Drive global site activation for complex, high-profile clinical trials with independence and compliance (Regeneron SOPs, ICH‑GCP, industry standards). Develop site start-up strategy, including dependencies, risk mitigation/escalation; create and align site activation projections; ensure TMF‑ready site documentation. Oversee tracking/analysis of study metrics to evaluate CRO performance and drive corrective actions. Lead country start-up strategy; maintain country intelligence; support regulatory submissions (CIRB/LIRB coordination, site documentation, CRO insurance requests). Manage site start-up activities (fast-track initiation, site calls, document collection, milestone tracking) and oversee CRO/in‑house SSU regional execution. Serve as subject matter expert for essential site documents; train and guide teams/sites on regulatory requirements, document management, and TMF filing. Represent SSU on cross‑functional teams; elevate issues and ensure timely resolution. Recommend and drive cross‑functional/department process improvements. Direct line management of SSU staff (work assignments, performance management, recruiting, development, coaching/mentoring, training, study oversight); may require up to 25% travel. Qualifications and Skills Bachelor’s degree; 8+ years of relevant industry experience; preference for sponsor site start‑up experience. Leadership, data‑driven planning/problem‑solving, strong verbal/written/presentation skills. Ability to influence/negotiation across stakeholders and manage vendors. Technical proficiency: CTMS, TMF, MS Project/PowerPoint/Word/Excel. Extensive clinical drug development experience (including study start‑up); strong ICH/GCP and regulatory knowledge; strong project management. #J-18808-Ljbffr