Global Clinical Study Lead, Immunology Trials

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

Job summary

Regeneron is seeking a Senior Clinical Study Lead to join the Clinical Trial Management team in Armonk, NY, supporting Inflammation & Immunology trials. You will lead large, complex trials from design through close-out with global responsibility for timelines, budget, and quality in accordance with ICH/GCP and Regeneron SOPs.

This role requires extensive line management of CTM staff, cross-functional leadership, and oversight of study documentation, vendors, and trial systems (CTMS, TMF, EDC).

Qualifications

• Bachelor's degree required and at least 8 years of clinical trial experience.
• Experience with line management and strong interpersonal/leadership skills.
• Advanced trial management skills with MS Office and CTMS/EDC familiarity.

Responsibilities

• Leads the cross-functional study team responsible for clinical study delivery.
• Oversees development of study documents (CRF, DMP, monitoring plans, SAP).
• Manages CTMS and TMF setup and maintenance.
• Identifies outsourcing needs and oversees vendor management.
• Contributes to budget and baseline timeline development and monitoring.
• Leads risk assessment and regional feasibility for studies.
• Oversees patient recruitment, retention, data entry, and query resolution.
• Oversees drug supply forecasting and reconciliation.
• Escalates issues to Program Operations Leader (POL) and implements actions.
• Manages study close-out activities including database lock and accounting.

Skills

Line management

Leadership

Interpersonal skills

Cross-functional collaboration

Project management

Deadline prioritization

Communication

Education

Bachelor's degree

Tools

CTMS

TMF

EDC

IVRS/IWRS

PowerPoint

Word

Excel

Job description

Regeneron is seeking a Senior Clinical Study Lead to join the Clinical Trial Management team in Armonk, NY, supporting Inflammation & Immunology trials. You will lead large, complex trials from design through close-out with global responsibility for timelines, budget, and quality in accordance with ICH/GCP and Regeneron SOPs.

This role requires extensive line management of CTM staff, cross-functional leadership, and oversight of study documentation, vendors, and trial systems (CTMS, TMF, EDC).