Clinical Study Lead: Trial Delivery & Vendor Oversight

Regulatory Jobs; New York (NY); Hybrid; USD 110,000 - 179,000; Full time

Job summary

Regeneron is seeking an experienced Clinical Study Associate Manager to support the Clinical Study Lead in delivering clinical trials. You will help plan, manage, and monitor studies, collaborate with CROs and vendors, and contribute to study documentation, data quality, and recruitment strategies.

The role involves on-site work with hybrid flexibility in locations including Armonk, NY, Warren, NJ, and Cambridge, MA, and may require travel up to 25%.

Qualifications

• Bachelor's Degree and 4+ years of relevant industry experience.
• Data-driven approach to executing and problem solving.
• Knowledge of ICH/GCP and regulatory guidelines.

Responsibilities

• May lead/oversee planning and management of a clinical study in assigned region(s).
• Contributes to risk assessment and mitigation strategies and feasibility assessments.
• Oversees development and review of study documentation (CRF, DMP, MP, TMF) and site consents.
• Manages study systems setup (CTMS, TMF) and investigator meeting support.
• Oversees vendor engagement, contracting, forecasting and drug accountability.
• Monitors recruitment, retention and site activation progress.
• Supports data quality and escalation of data issues to the Study Lead.

Skills

Data-driven mindset

Budget awareness

Vendor management

Clinical trial operations

ICH/GCP knowledge

Cross-functional collaboration

Education

Bachelor's degree

Tools

MS Project

PowerPoint

Word

Excel

IVRS/IWRS

EDC

TMF

Job description

Regeneron is seeking an experienced Clinical Study Associate Manager to support the Clinical Study Lead in delivering clinical trials. You will help plan, manage, and monitor studies, collaborate with CROs and vendors, and contribute to study documentation, data quality, and recruitment strategies.

The role involves on-site work with hybrid flexibility in locations including Armonk, NY, Warren, NJ, and Cambridge, MA, and may require travel up to 25%.