Senior Manager Global Site Management and Monitoring

Regeneron Pharmaceuticals, Inc.; Uxbridge; On-site; GBP 80,000 - 100,000; Full time

Job summary

A global biopharmaceutical company in Uxbridge is seeking a Senior Manager, Global Site Management to enhance clinical trial operations. In this role, you will develop risk-based monitoring strategies, ensure compliance, and collaborate with clinical teams. Applicants should have a Bachelor's Degree and 8+ years of experience in clinical trials and monitoring. The position requires knowledge of ICH/GCP standards and up to 25% travel. Join a dynamic team dedicated to driving innovation and improving study efficiencies.

Benefits

Health and wellness programs

401(k) company match

Annual bonuses

Qualifications

• 8+ years of experience in clinical trial operations, monitoring, and site management.
• Proven understanding of ICH/GCP standards.
• Familiarity with medical terminology and industry regulations.

Responsibilities

• Develop study-specific risk-based monitoring strategies.
• Collaborate with Clinical Trial Management teams.
• Oversee performance metrics and risk indicators.

Skills

Risk-based monitoring strategies

Collaboration skills

Medical terminology

Understanding of ICH/GCP standards

Education

Bachelor's Degree

Job description

At Regeneron, we believe that when the right idea finds the right team, powerful change is possible. We're looking for a Senior Manager, Global Site Management and monitoring, to join our team and play a pivotal role in coordinating and improving the delivery of clinical trial operations. In this role, you'll contribute to the planning, execution, and oversight of our clinical trial portfolio, ensuring collaboration among internal teams, external vendors, and investigator sites. With opportunities to drive innovation and process improvement, this position offers meaningful impact in advancing clinical trial strategies and methodologies.

• Develop and be responsible for study-specific risk-based monitoring strategies to ensure compliance and efficiency, while managing vendor relationships, including onboarding, performance evaluations and resource alignment.
• Collaborate with Clinical Trial Management teams to design monitoring strategies aligned with RBQM methodologies, including budget planning and approval.
• Provide input to monitoring plans, ensuring alignment with critical data specifications and SDR/SDV approaches.
• Oversee and evaluate performance metrics and risk indicators, providing intervention as needed.
• Act as an SME for monitoring/site management topics, offering guidance to internal and external stakeholders.
• Support inspection readiness activities and participate in regulatory GCP inspections and audits.
• You excel in collaborative environments while maintaining the ability to work independently.
• You are skilled in establishing relationships with stakeholders and translating strategies into actionable frameworks.
• You are familiar with medical terminology and industry regulations, including ICH/GCP standards.

Applicants must have a Bachelor's Degree and at least 8 years of proven experience in clinical trial operations, monitoring, and site management. A proven understanding of ICH/GCP standards and familiarity with medical terminology are crucial. Preferred qualifications include experience in risk-based monitoring methodologies and expertise in collaborating with CROs and FSPs. This position involves traveling up to 25% of the time to support site management activities.

Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries' specific benefits, please speak to your recruiter.