Clinical Study Manager: Trial Delivery & Vendor Oversight

Regeneron Pharmaceuticals, Inc.; New Jersey; On-site; USD 90,000 - 130,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. seeks a Temporary Clinical Study Associate Manager to support the Clinical Trial management team. You will assist the Study Lead in delivering studies and coordinating with CROs.

Responsibilities include planning, risk mitigation, study documentation, CTMS/TMF setup and maintenance, and budget oversight.

You will work with vendors, monitor site activity, ensure data quality, and contribute to inspections readiness and study close-out.

Qualifications

• Bachelor's degree required with 4+ years in clinical trial operations or equivalent.

Responsibilities

• Lead or oversee planning and management of clinical studies in assigned regions.
• Contribute to risk assessment and mitigation planning.
• Oversee study documentation development and site start-up materials.
• Maintain CTMS and TMF systems; support investigator meeting activities.
• Engage, contract, and manage vendors for the study.
• Monitor recruitment, data quality, and site activity.
• Support budget management and scope changes.
• Assist in audits, inspections, and CAPAs as needed.
• Oversee study close-out activities including database lock and drug accountability.

Skills

Data-driven approach

Trial management systems

MS Office (Project, PowerPoint, Word,‑

Budget management

Vendor management

ICH/GCP knowledge

Education

Bachelor's Degree

Tools

IVRS/IWRS

EDC

TMF

Job description

Regeneron Pharmaceuticals, Inc. seeks a Temporary Clinical Study Associate Manager to support the Clinical Trial management team. You will assist the Study Lead in delivering studies and coordinating with CROs.

Responsibilities include planning, risk mitigation, study documentation, CTMS/TMF setup and maintenance, and budget oversight.

You will work with vendors, monitor site activity, ensure data quality, and contribute to inspections readiness and study close-out.