Hybrid Clinical Study Manager: Trials & Vendors

Regeneron Pharmaceuticals, Inc.; Warren (MI); On-site; USD 110,000 - 179,000; 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, lead study activities in assigned regions, and oversee vendor engagement and forecasting for trials, including CTMS and TMF oversight. The role requires a data-driven approach, strong regulatory knowledge, and experience in developing study documents.

Qualifications

• Data driven approach to executing and problem solving.
• Attention to detail to deliver on study activities.
• Familiarity with medical terms and vendor management experience.
• Experience in clinical trial operations and developing key study documents.
• Knowledge of ICH/GCP and regulatory guidelines/directives.

Responsibilities

• May lead/oversee planning and management of a clinical study in assigned region(s).
• Contributes to risk assessment and risk mitigation strategies.
• Develops and reviews study documents (CRF, data management plan, monitoring plan, oversight plan).
• Oversees setup and maintenance of study systems (CTMS, TMF).
• Manages engagement, contracting and oversight of vendors and drug forecasting/recall.
• Provides status reports to the Clinical Study Lead and helps develop recruitment and retention strategies.
• Monitors recruitment, site activation, monitoring visits, and data quality issues.
• Supports budget management and scope changes; contributes to audits and CAPAs.
• Manages study close-out activities including database lock and TMF reconciliation.

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 join our Clinical Trial management team in the United States.

You will support the Clinical Study Lead, lead study activities in assigned regions, and oversee vendor engagement and forecasting for trials, including CTMS and TMF oversight. The role requires a data-driven approach, strong regulatory knowledge, and experience in developing study documents.