Senior Manager Global Site Management

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

Resumo da oferta

Regeneron Pharmaceuticals, Inc. is seeking a Senior Manager, Global Site Management to join our Global Development team in a hybrid role supporting our global clinical trial portfolio.

You will design and lead risk-based monitoring strategies and site management across studies, partnering with Clinical Trial Management, Central Monitoring, Quality, and external partners. You will oversee CRO/FSP monitoring activities, evaluate KRIs, and drive inspection readiness, study performance, and

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 working within a RBQM framework.
• Working knowledge of ICH-GCP guidelines and applicable regulatory requirements.

Responsabilidades

• 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.

Conhecimentos

Risk-based monitoring

Site management

CRO/FSP management

RBQM

Regulatory knowledge

Cross-functional collaboration

Communication skills

Formação académica

Bachelor's degree

Descrição da oferta de emprego

Build Our Future Together

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!

When & Where:

• Location: Warren, NJ or Armonk, NY
• Work Model/Flexibility: Hybrid 3 days a week
• Shift Requirements: Standard business hours
• Travel: Up to 25%

Discover Your Role

• 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.

This Role Requires

• 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.

Preferred Qualifications

• 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.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: 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, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . For other locations, additional information will be provided during the recruitment process.

Salary Range (annually)
$134,400.00 - $219,200.00

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.