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; escalate 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/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.

Application:
- Apply now to take your first step toward living the “Regeneron Way.”