What are the responsibilities and job description for the Clinical Trials Operations Lead position at Regeneron Pharmaceuticals?
As a Senior Clinical Study Lead at Regeneron, you will be accountable for the successful delivery of global clinical trials. This role requires a high degree of independence and oversight of study timelines, ensuring compliance with ICH/GCP.
Responsibilities:
- Lead cross-functional study teams to deliver high-quality trial results
- Provide operational input into protocol development and feasibility assessments
- Oversee the development and review of study-specific documentation
- Monitor data entry and query resolution processes
- Identify outsourcing needs and lead vendor engagement and contracting
- Develop and implement risk mitigation strategies
Qualifications:
- Minimum 8 years of relevant industry experience
- Exceptional leadership and communication skills
- Advanced expertise in operational strategic direction and guidance
