Manager Central Monitoring

About the role

Regeneron is seeking a Manager, Central Monitoring to join its Clinical Study team and support global, complex clinical development trials. You will analyze risk and performance data, identify emerging issues, and guide sponsor oversight while collaborating with study teams, data analysts, and CRO partners.

Key responsibilities

• Lead centralized monitoring reviews for assigned global and complex studies within a therapy area or program.
• Interpret key risk and performance indicators to spot trends and sites that may need sponsor intervention.
• Author the Central Monitoring Plan and contribute to study quality risk assessments.
• Present findings and recommended actions to study teams, at CRO kick‑off, and in quality risk review meetings.
• Partner with data analysts to configure and run the risk‑based quality management system.
• Oversee CRO central monitoring activities to ensure alignment with agreed standards.
• Represent Central Monitoring in audit and inspection preparation as a subject‑matter expert.
• Drive process improvements and delegate tasks to the Central Monitoring Associate Manager.

Required profile

• Bachelor's degree with at least 7 years of biotechnology/pharmaceutical experience, including a minimum of 1 year in direct Central Monitoring.
• Working knowledge of the clinical drug development process, ICH and GCP guidelines and regulations.
• Preferred experience in site monitoring or data management.
• Proficiency in Microsoft Office applications.

Required skills

• Microsoft Office applications.
• Knowledge of ICH and GCP guidelines.

What we offer

• Competitive total rewards package including annual bonuses, equity awards, and pension/retirement benefits.
• Health and wellness programs, fitness centers, and comprehensive insurance (medical, dental, vision, life, disability).
• Paid time off and family support benefits.