Senior Clinical Study Manager, Trials & Vendors

Regeneron Pharmaceuticals, Inc (USA); Kentucky; On-site; USD 112,000 - 183,000; Full time

Benefits offered by this job

Annual bonuses or other incentiveplans

Equity awards

Pension or retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits (medical, dental, +

Paid time off

Family support benefits

Job summary

Regeneron Pharmaceuticals, Inc (USA) is seeking a Clinical Study Associate Manager to support the Clinical Study Lead in delivering studies, including local and CRO-managed trials. The role involves planning, risk assessments, study documentation, and budget oversight, with on-site responsibilities in locations across the U.S.

and travel as needed. You will ensure data quality, coordinate with vendors, and help drive recruitment and retention efforts while adhering to ICH/GCP guidelines and

Qualifications

• Bachelor's degree; 4+ years in clinical operations or related field.
• Experience developing key study documents and trial deliverables.
• Familiarity with ICH/GCP and regulatory guidelines.

Responsibilities

• May lead/oversee planning and management of a clinical study in assigned regions.
• Contributes to risk assessment and mitigation strategies; supports feasibility assessments.
• Oversees study documents (CRFs, data management plan, monitoring plan) and site-level materials.
• Maintains study systems (CTMS, TMF) and supports investigator meetings.
• Manages vendors, drug forecasting, accountability, and reconciliation; supports recruitment/retention strategies.

Skills

Data-driven problem solving

Attention to detail

Trial management systems

MS Office (Project, PowerPoint, Word,?

Education

Bachelor's Degree

Tools

Project

PowerPoint

Word

Excel

IVRS/IWRS

EDC

TMF

Job description

Regeneron Pharmaceuticals, Inc (USA) is seeking a Clinical Study Associate Manager to support the Clinical Study Lead in delivering studies, including local and CRO-managed trials. The role involves planning, risk assessments, study documentation, and budget oversight, with on-site responsibilities in locations across the U.S.

and travel as needed. You will ensure data quality, coordinate with vendors, and help drive recruitment and retention efforts while adhering to ICH/GCP guidelines and