Clinical Study Manager — Regional Trials & Oversight

Regeneron Pharmaceuticals, Inc.; Village of Tarrytown (NY); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Clinical Study Associate Manager to support the Clinical Trial Management team. You will help lead study planning, risk assessment, and site management, collaborating with CROs and internal stakeholders.

Responsibilities include overseeing study documentation, CTMS/TMF setup, vendor engagement, and budget oversight, while monitoring recruitment, data quality, and study timelines to ensure successful delivery.

Qualifications

• Bachelor's Degree and 4+ years of relevant industry experience.
• Data-driven approach to executing and solving problems with attention to detail.
• Technical proficiency in trial management systems and MS applications listed above.
• Knowledge of ICH/GCP and regulatory guidelines/directives.

Responsibilities

• May lead planning and management of a clinical study in assigned region(s).
• Contribute to risk assessment and feasibility to select regions/countries.
• Oversee development of study documentation and review patient materials.
• Oversee setup and maintenance of CTMS and TMF; support investigator meetings.
• Engage vendors, manage contracts, and oversee drug forecasting and reconciliation.
• Provide regular status reports and assist recruitment/retention strategies.
• Monitor recruitment, site activation, and monitoring visits.
• Support data quality through reviews of metrics, deviations, and non-compliance.
• Oversee deliverables against timelines; escalate budget/timeline issues.
• Support audits/CAPAs and study close-out activities as needed.

Skills

Data-driven problem solving

Attention to detail

Budget management awareness

Vendor management experience

Clinical trial operations

ICH/GCP knowledge

Strong communication skills

Education

Bachelor's degree

Tools

MS Project

PowerPoint

Word

Excel

IVRS/IWRS

EDC

TMF

Job description

Regeneron Pharmaceuticals, Inc. is seeking a Clinical Study Associate Manager to support the Clinical Trial Management team. You will help lead study planning, risk assessment, and site management, collaborating with CROs and internal stakeholders.

Responsibilities include overseeing study documentation, CTMS/TMF setup, vendor engagement, and budget oversight, while monitoring recruitment, data quality, and study timelines to ensure successful delivery.