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About the role
- Senior Manager driving global execution of site activation for complex clinical trials at Regeneron. Leading cross-functional collaboration and ensuring compliance with regulatory standards.
Responsibilities
- Drive the global execution of site activation for complex, high profile clinical trials
- Partner closely with cross-functional teams and Clinical Research Organizations (CROs)
- Develop site activation projections, mitigate risks impacting site activation, and monitor CRO performance by analyzing metrics
- Lead all aspects of site start-up activities, including fast-track initiation, milestone tracking, and document collection
- Ensure comprehensive and compliant documentation of site start-up materials in the Trial Master File (TMF) to maintain inspection readiness
- Provide training, guidance, and support to teams and sites on regulatory requirements, document management, and TMF filing
- Serve as the subject matter expert for essential site documents
- Lead and oversee all aspects of site start-up activities for complex, high profile studies
Requirements
- Strong interpersonal and leadership skills
- Ability to provide and implement operational strategic direction and guidance for respective clinical trials
- Demonstrates strong knowledge and a data-driven approach to planning, executing, and problem-solving
- Strong communication skills via verbal, written and presentation abilities
- Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
- Ability to influence and negotiate across a wide range of stakeholders
- Ability to lead and develop productive study teams and collaborations
- Applies advanced negotiation and interpersonal skills to vendor management
- Strong technical proficiency in trial management systems (CTMS, TMF) and MS applications including (but not limited to) Project, PowerPoint, Word, Excel
- Extensive experience in the clinical drug development process, including study start-up
- Knowledge and understanding of ICH/GCP and regulatory guidelines/directives
- Strong project management skills, cross-functional team interaction and organizational skills
- Line management experience preferred
Benefits
- health and wellness programs (including medical, dental, vision, life, and disability insurance)
- fitness centers
- 401(k) company match
- family support benefits
- equity awards
- annual bonuses
- paid time off
- paid leaves (e.g., military and parental leave) for eligible employees at all levels!
Job title
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