Manager Clinical Study Lead
Regeneron · Armonk +1 more
Clinical OperationsFull-time$129k–$210kCompany career page
The apply link worked recently (not employer-confirmed).
What they're looking for
- Bachelor's degree and six years of clinical trial operations experience
- Extensive budget management expertise and vendor management experience
- Technical proficiency with trial management systems, IVRS/IWRS, EDC, and Microsoft Office
- Knowledge of ICH/GCP guidelines, regulatory requirements, and protocol development
- Strong project management, cross-functional leadership, and organizational skills
What you'll be doing
- Lead global execution of assigned clinical trials from design through closeout, managing timelines, budgets, and regulatory compliance
- Oversee cross-functional study teams, site selection, investigator meetings, and study documentation development
- Manage vendor engagement and CRO relationships; ensure alignment with scope of work and contractual obligations
- Lead study risk assessment, patient recruitment strategies, and data monitoring; address deviations from plan
- Supervise Clinical Study Management staff; drive process improvements and study closeout activities including database lock and lessons learned
Privacy & handoff
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