Senior Manager Global Site Management and Monitoring

At Regeneron, we believe that when the right idea finds the right team, powerful change is possible. We are 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 will 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.

Responsibilities:

• 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.

Qualifications:

This Role May Be For You If:

• You have extensive experience with risk-based quality operating models and clinical trial operations.
• 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.

To Be Considered:

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 travelling up to 25% of the time to support site management activities.

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 Regeneron Benefits. For other countries specific benefits, please speak to your recruiter.

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.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.

The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.