Regeneron is seeking a Senior Manager, Central Monitoring to be accountable for centralized monitoring activities for global and complex trials. As an integral member of the Clinical Study team, you will drive program-level analytical data review within our clinical development studies.

What You'll Do

Be accountable for centralized monitoring activities for global or complex trials and program-level analytical data review.
Interpret Key Risk Indicator (KRI) and Key Performance Indicator (KPI) data within analytical tools.
Conduct comprehensive review of supplemental operational data, trends, and issues to report to study teams.
Develop and author the Central Monitoring Plan.
Participate in Quality Risk and Control Tracker (QRACT) development.
Present at CRO kick-off meetings.
Work with data analysts on technical configuration and execution of the Central Monitoring RBQM system.
Conduct and communicate study-level and program-level Central Monitoring Review for assigned studies.
Interpret relationships between KPIs and supporting data to critically assess site and study trends.
Review and report data to identify centralized monitoring activities or sites requiring sponsor intervention.
Support study teams in understanding findings and defining appropriate follow-up actions.
Document outputs from Central Monitoring Review meetings and track decisions to closure.
Access and complete applicable tracking and reporting tools.
Define strategies and provide insights for Central Monitoring under the RBQM operating model.
Present at periodic study and program-level Quality Risk Review meetings.
Act as a subject matter expert for Central Monitoring implementation and execution.
Represent Central Monitoring during audit and inspection preparation and conduct.
Partner with outsourcing management and CROs to align on monitoring strategies and standards.
Provide oversight of CRO partner central monitoring activities.
Critically evaluate data, metrics, and reports to ensure they meet Central Monitoring review needs.
Represent Central Monitoring in process improvement initiatives and strategic planning.
Assess and evaluate the Central Monitoring Process for enhancements.
Assign and delegate tasks to Central Monitoring Associate Managers and Managers.
Perform line management activities including goal setting, performance assessments, coaching, and development planning.

What We're Looking For

A minimum of a Bachelor’s degree.
At least 8 years of relevant experience in the biotechnology or pharmaceutical industry.
A minimum of 3 years with direct Central Monitoring experience.

Nice to Have

Site monitoring or data management experience.

Technical Stack

CluePoint or similar RQBM system for Central Monitoring.
Microsoft Office applications.

Team & Environment

You will support a number of studies within a therapy area and at the program-level. You'll work closely with other Central Monitors and may have direct reports including Central Monitoring Associate Managers and Managers. You will be an integral member of the Clinical Study team.

Benefits & Compensation

Compensation range: $134,400.00 - $219,200.00 annually.
Health and wellness programs (medical, dental, vision, life, and disability insurance).
Fitness centers.
401(k) company match.
Family support benefits.
Equity awards.
Annual bonuses.
Paid time off.
Paid leaves (e.g., military and parental leave).

Work Mode

This position is onsite.

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, 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.