Clinical Study Operations Lead

Regeneron Pharmaceuticals, Inc.; Kentucky; On-site; USD 85,000 - 110,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Clinical Study Associate Manager to join our Clinical Trial management team in the United States.

You will support the Clinical Study Lead across internally sourced and CRO-staffed studies, collaborating with vendors and the internal study team to deliver trial milestones. Responsibilities include leading study planning, risk assessment, document development, system setup (CTMS, TMF), vendor engagement, recruitment strategies, and budget management.

Qualifications

• Bachelor's degree and 4+ years of relevant industry experience.
• Proficient with trial management systems and MS Office applications.
• Knowledge of ICH/GCP and regulatory guidelines.

Responsibilities

• Lead/oversee planning and management of a clinical study in assigned region(s) in alignment with global study plans.
• Contribute to risk assessment and mitigation strategies and support feasibility assessments.
• Develop and review study documents (CRF, data management plan, monitoring plan).
• Set up and maintain study systems (CTMS, TMF) and support investigator meeting prep.
• Engage, contract and manage vendors; oversee drug forecasting and reconciliation.
• Provide regular status reports and help develop recruitment/retention strategies.
• Monitor site recruitment, activation, and monitoring visits; ensure data quality.
• Oversee study close-out activities including database lock, budget reconciliation, and TMF.

Skills

Data-driven problem solving

Attention to detail

Budget awareness

Vendor management

ICH/GCP knowledge

Education

Bachelor's degree

Tools

MS Office (Project, PowerPoint, Word, Excel)

Trial management systems

EDC

TMF/CTMS

IVRS/IWRS

Job description

Regeneron Pharmaceuticals, Inc. is seeking a Clinical Study Associate Manager to join our Clinical Trial management team in the United States.

You will support the Clinical Study Lead across internally sourced and CRO-staffed studies, collaborating with vendors and the internal study team to deliver trial milestones. Responsibilities include leading study planning, risk assessment, document development, system setup (CTMS, TMF), vendor engagement, recruitment strategies, and budget management.