Senior Global Clinical Study Lead

BioSpace; Armonk (NY); On-site; USD 129,000 - 210,000; Full time

Job summary

Regeneron is seeking a Manager, Clinical Study Lead to drive global execution of clinical trials from design to closeout. You will own study timelines, budgets, and SOP/ICH-GCP compliance, coordinating with CROs and internal teams to maintain quality and timelines.

The role requires leading cross-functional teams, overseeing study documentation, and contributing to process improvements. Onsite work in Armonk, NY with travel may be required.

Qualifications

• Bachelor's degree required with at least six years in clinical trials or related field.
• Strong budget management and vendor management experience.
• Proficiency with trial management systems and MS Office apps (Project, PowerPoint, Word, Excel).
• Experience in global clinical trial operations, protocol development, and key study documents.
• Ability to lead cross-functional teams and execute operational strategy.

Responsibilities

• Leads cross-functional study team for clinical study delivery, ensuring timelines, deliverables, and budget.
• Oversees protocol development input, site selection, and investigator meeting execution.
• Manages study documentation and systems setup (CTMS, TMF) to meet regulatory requirements.
• Assesses outsourcing needs, engages CROs, and ensures performance per scope of work.
• Manages baseline budget, timelines, risk assessment, and patient recruitment strategies.

Skills

Budget management

Vendor management

Cross-functional leadership

ICH/GCP knowledge

Trial management systems

MS Office (Project, PowerPoint, Word, 

Education

Bachelor's degree

Tools

IVRS/IWRS

EDC

Project

PowerPoint

Word

Excel

Job description

Regeneron is seeking a Manager, Clinical Study Lead to drive global execution of clinical trials from design to closeout. You will own study timelines, budgets, and SOP/ICH-GCP compliance, coordinating with CROs and internal teams to maintain quality and timelines.

The role requires leading cross-functional teams, overseeing study documentation, and contributing to process improvements. Onsite work in Armonk, NY with travel may be required.