Stellenbeschreibung
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 Manager, Central Monitoring to join our Clinical Study team, supporting global and complex clinical development trials. In this role, you will analyze key risk and performance data to identify emerging issues and guide sponsor oversight decisions, while collaborating with study teams, fellow Central Monitors, data analysts, and CRO partners.
This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
When & where:
- Location: United States
- Work model/flexibility: Remote
- Travel percentage: Up to 25%
Discover your role:
- Lead centralized monitoring reviews for assigned global and complex studies within a therapy area or program
- Interpret key risk and performance indicators to spot trends and sites that may need sponsor intervention
- Author the Central Monitoring Plan and contribute to study quality risk assessments
- Present findings and recommended actions to study teams, at CRO kick-off, and in quality risk review meetings
- Partner with data analysts to configure and run our risk-based quality management system
- Oversee CRO central monitoring activities to ensure alignment with agreed standards
- Represent Central Monitoring in audit and inspection preparation as a subject matter expert
- Drive process improvements and delegate tasks to the Central Monitoring Associate Manager
This role might be for you if:
- You enjoy turning complex data into clear insights
- You are a resourceful problem-solver who troubleshoots with curiosity
- You communicate clearly, both in writing and in front of a study team
- You build strong relationships with internal colleagues and external partners
- You stay curious about emerging trends and technologies in clinical trial oversight
- You are comfortable taking ownership as the go-to expert on central monitoring
This role requires:
- Bachelor's degree and at least 7 years of relevant biotechnology/pharmaceutical experience, including a minimum of 1 year of direct Central Monitoring experience
- Working knowledge of the clinical drug development process, ICH, and GCP guidelines and regulations. - Preferred: site monitoring or data management experience
- Proficiency in Microsoft Office applications
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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. If you have any questions, please speak with your recruiter.
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. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.
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.
Salary Range (annually)
$114,800.00 - $187,400.00