Hybrid Global Site Management & RBQM Lead

Regeneron Pharmaceuticals; Warren (MI); Híbrido; USD 134 000 - 219 000; Tempo integral

Resumo da oferta

Regeneron Pharmaceuticals is seeking a Senior Manager, Global Site Management to join the Global Development team in a hybrid role supporting our global clinical trial portfolio. You will design and lead risk-based monitoring strategies, ensure high-quality site management, and drive inspection readiness across studies.

Collaborate with Trial Management, Central Monitoring, Quality, and external partners to improve study performance and patient outcomes.

Qualificações

• 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 with RBQM framework and ICH-GCP guidelines.
• Proven experience overseeing CROs, FSPs, or external partners.

Responsabilidades

• Lead 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.
• Evaluate performance metrics, KRIs, 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.

Conhecimentos

Risk-based monitoring

RBQM

Site management

Regulatory knowledge

CRO/FSP oversight

Communication

Stakeholder management

Formação académica

Bachelor's degree

Descrição da oferta de emprego

Regeneron Pharmaceuticals is seeking a Senior Manager, Global Site Management to join the Global Development team in a hybrid role supporting our global clinical trial portfolio. You will design and lead risk-based monitoring strategies, ensure high-quality site management, and drive inspection readiness across studies.

Collaborate with Trial Management, Central Monitoring, Quality, and external partners to improve study performance and patient outcomes.