Global Site Management Lead — RBQM & Trials

Regeneron Pharmaceuticals, Inc; New Jersey; Hybrid; USD 134,000 - 219,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc in the United States is 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.

Qualifications

• 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.

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.

Skills

RBQM

Risk-based monitoring

Site management

Quality management

Cross-functional collaboration

Stakeholder management

Education

Bachelor's degree

Job description

Regeneron Pharmaceuticals, Inc in the United States is 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.