Senior Clinical Trials Operations Lead

Regeneron Pharmaceuticals, Inc.; Armonk (NY); On-site; USD 110,000 - 140,000; Full time

Job summary

Regeneron Pharmaceuticals is seeking a Clinical Study Associate Manager to support clinical trial delivery within a global management team. The role involves oversight of regional study planning, vendor management, study documentation, and system setup (CTMS, TMF), with site activation and recruitment responsibilities.

The candidate will contribute to risk mitigation, feasibility assessments, and inspection readiness, ensuring adherence to GxP and ICH/GCP guidelines while managing budgets and

Qualifications

• Bachelor's degree required.
• 4+ years in clinical operations.
• Proficiency with trial management systems (EDC, TMF, IVRS).
• Budget awareness.
• Vendor management experience.
• Knowledge of GxP and ICH/GCP guidelines.

Responsibilities

• Oversee regional study planning and vendor management.
• Manage study documentation and CTMS/TMF setup.
• Site activation, recruitment, data quality, and study close-out.
• Contribute to risk mitigation, feasibility, and inspection readiness.

Skills

Vendor management

Budget awareness

GxP knowledge

EDC familiarity

TMF familiarity

IVRS familiarity

Education

Bachelor's degree

Tools

EDC

TMF

IVRS

Job description

Regeneron Pharmaceuticals is seeking a Clinical Study Associate Manager to support clinical trial delivery within a global management team. The role involves oversight of regional study planning, vendor management, study documentation, and system setup (CTMS, TMF), with site activation and recruitment responsibilities.

The candidate will contribute to risk mitigation, feasibility assessments, and inspection readiness, ensuring adherence to GxP and ICH/GCP guidelines while managing budgets and