Senior Manager Global Study Start Up
Core
Driving global execution of site activation for complex, high-profile clinical trials with strategic oversight and hands-on leadership.
Role type
Senior Manager, Global Site Start-Up Lead
Builds
Efficient and compliant clinical trial site activation processes aligned with Regeneron SOPs and ICH-GCP guidelines.
Domain
Biopharmaceuticals / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic planning, risk mitigation, CRO performance analysis, site selection strategy, regulatory compliance (ICH-GCP), line management, data-driven decision-making, project management, vendor management, trial management systems proficiency
Preferred skills
Sponsor Site Start-Up experience
Technologies
CTMS, TMF, Microsoft Project, PowerPoint, Word, Excel
Responsibilities
Develop site start-up strategies and mitigate risks; oversee CRO performance and corrective actions; lead site activation activities including fast-track initiation and milestone tracking; manage regulatory submissions and documentation; supervise SSU staff including recruitment and development; represent SSU on cross-functional teams.
Seniority
Senior, hands-on IC with line management responsibilities
