Senior Clinical Study Lead, Global Trials & Strategy

BioSpace; Armonk (NY); Hybrid; USD 151,000 - 246,000; Full time

Job summary

Regeneron is seeking a Senior Clinical Study Lead to drive the global execution of large and complex clinical trials in Inflammation & Immunology. The role ensures study timelines and budgets align with SOPs and ICH/GCP, with accountability for CRO oversight as needed.

The position requires extensive trial operations experience, strong leadership, and the ability to manage end-to-end study activities from design through close-out.

Qualifications

• Bachelor's degree required with 8+ years clinical trial experience.
• Experience leading and managing a cross-functional study team.
• Advanced proficiency in trial management systems and MS applications.

Responsibilities

• Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact for leadership for the assigned study.
• Oversees study documentation and systems setup (CTMS, TMF, etc.).
• Identifies outsourcing needs and leads vendor engagement and management.
• Contributes to budget and timeline development and management.
• Leads risk assessment and regional feasibility to select study regions/countries.
• Oversees patient recruitment, retention strategies, and data query resolution.
• Manages study close-out activities including database lock and TMF reconciliation.

Skills

Leadership

Cross-functional

Trial management

Communication

MS Office

Education

Bachelor's degree

Tools

CTMS

TMF

EDC

IVRS/IWRS

Job description

Regeneron is seeking a Senior Clinical Study Lead to drive the global execution of large and complex clinical trials in Inflammation & Immunology. The role ensures study timelines and budgets align with SOPs and ICH/GCP, with accountability for CRO oversight as needed.

The position requires extensive trial operations experience, strong leadership, and the ability to manage end-to-end study activities from design through close-out.