Senior Clinical Study Lead — Global Trial Execution

Regulatory Jobs; New York (NY); On-site; USD 151,000 - 246,000; Full time

Job summary

Regeneron seeks a Senior Clinical Study Lead to drive global trials in the Inflammation & Immunology area. You will own study design through close-out, ensure SOP/ICH-GCP compliance, and lead cross-functional teams, vendors, and budgets.

On-site with hybrid flexibility in Armonk NY area, travel up to 25% may be required. Responsibilities include overseeing study documentation, CTMS/TMF setup, and data review plans, plus budgeting and timelines.

Qualifications

• Bachelor's degree required; 8+ years of clinical trial experience.
• Proven line management and leadership skills.
• Ability to influence across diverse stakeholders and meet deadlines.
• Advanced proficiency with trial management systems and MS applications.
• Extensive global clinical trial operations experience and protocol development input.

Responsibilities

• Leads cross-functional study team and acts as primary contact for leadership.
• Oversees study documentation, systems setup (CTMS, TMF) and data review plans.
• Manages outsourcing, vendor engagement, contracting, and oversight.
• Contributes to budget and timeline development and management.
• Leads risk assessment, site activation monitoring, and patient recruitment strategies.
• Oversees study drug forecasting, accountability, and close-out activities.
• Supervises CTM staff, including performance management and mentoring.

Skills

Cross-functional leadership

Clinical trial management

Line management

Budget management

Vendor management

ICH/GCP knowledge

CTMS

EDC

MS Office (PowerPoint, Word, Excel)

Education

Bachelor's degree

Tools

CTMS

TMF

EDC

IVRS/IWRS

MS Office

Job description

Regeneron seeks a Senior Clinical Study Lead to drive global trials in the Inflammation & Immunology area. You will own study design through close-out, ensure SOP/ICH-GCP compliance, and lead cross-functional teams, vendors, and budgets.

On-site with hybrid flexibility in Armonk NY area, travel up to 25% may be required. Responsibilities include overseeing study documentation, CTMS/TMF setup, and data review plans, plus budgeting and timelines.