Senior Manager Global Site Management
About The Position
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager, Global Site Management to join our Global Development team in a hybrid role supporting our global clinical trial portfolio. In this position, you will play a meaningful role in designing and leading all aspects of risk-based monitoring strategies, ensuring high-quality site management and operational execution across clinical studies. Working closely with Clinical Trial Management, Central Monitoring, Quality, and external partners, you will help drive inspection readiness, study performance, and patient-focused outcomes. This is an opportunity to supply to a science-driven organization committed to advancing innovative therapies for patients worldwide!
Requirements
- Bachelor's degree and 8+ years of proven experience in clinical research, clinical operations, site management, monitoring, or related pharmaceutical/biotechnology environments.
- Strong knowledge of clinical trial operations, risk-based monitoring methodologies, and site management practices.
- Experience working within a Risk-Based Quality Management (RBQM) framework.
- Working knowledge of ICH-GCP guidelines and applicable regulatory requirements.
- Demonstrated experience managing and overseeing CROs, Functional Service Providers (FSPs), or external clinical partners.
- Excellent communication, collaboration, organizational, and stakeholder management skills.
Nice To Haves
- Experience developing monitoring plans, critical data identification strategies, and targeted Source Data Verification (tSDV) approaches.
- Experience supporting global clinical studies across multiple countries and regions.
- Familiarity with performance metrics, Key Risk Indicators (KRIs), and operational risk management processes.
- Proven ability to influence cross-functional teams and drive process improvement initiatives.
- Experience participating in regulatory inspections, audits, and inspection readiness activities.
- Strong critical thinking, problem-solving, and decision-making capabilities in complex clinical development environments.
Responsibilities
- Lead the development and implementation of study-specific risk-based monitoring and site management strategies across global clinical programs.
- Partner with Clinical Trial Management teams to identify critical data, key study risks, and appropriate monitoring approaches.
- Provide oversight of CRO and FSP monitoring activities to ensure quality, compliance, and study execution objectives are achieved.
- Evaluate performance metrics, key risk indicators, and operational trends to proactively identify and mitigate study risks.
- Collaborate with cross-functional partners to support study planning, budget forecasting, inspection readiness, and operational excellence.
- Establish productive relationships with investigator sites, CRO partners, and internal stakeholders to drive study performance and data quality.
- Act as a subject matter expert in risk-based quality management (RBQM), monitoring strategy, and site management standards.
- Contribute to process improvement initiatives and innovation efforts that enhance clinical trial delivery and operational efficiency.
Benefits
- annual bonuses or other incentive plans
- equity awards
- pension or retirement benefits
- 401(k) company match
- health and wellness programs
- fitness centers
- insurance benefits (e.g. medical, dental, vision, life and disability)
- paid time off
- family support benefits
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What This Job Offers
Job Type
Full-time
Career Level
Senior
