Senior Global Clinical Study Lead

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

Job summary

Regeneron seeks a Manager, Clinical Study Lead to drive the global execution of smaller or less complex clinical trials from design to closeout. You will manage timelines, budgets, and ensure study conduct aligns with SOPs and ICH/GCP.

The role covers internal studies and CRO engagements, with a focus on continuous improvement of CTM processes and reliable delivery across functional partners.

Qualifications

• Bachelor's degree and at least six years of relevant industry experience.
• Extensive budget management expertise.
• Strong technical proficiency with trial management systems and Microsoft applications (Project, PowerPoint, Word, Excel) and platforms such as IVRS/IWRS and EDC.
• Experience in global clinical trial operations, including protocol development and key study documents.
• Ability to understand and implement the operational strategic direction for clinical studies.

Responsibilities

• Leads the cross-functional study team responsible for clinical study delivery and oversees execution against timelines, deliverables, and budget.
• Provides operational input into protocol development and feasibility assessments; oversees site evaluation and investigator meeting execution.
• Oversees study documentation including case report forms, data management plan, monitoring plan, and statistical analysis plan.
• Manages setup and maintenance of study systems (CTMS, TMF) and ensures regulatory compliance.
• Identifies outsourcing needs and leads CRO/vendor engagement, contracting, and management.

Skills

Budget management

Vendor management

Cross-functional leadership

Project management

ICH/GCP knowledge

Education

Bachelor's degree

Tools

MS Project

PowerPoint

Word

Excel

IVRS/IWRS

EDC

Job description

Regeneron seeks a Manager, Clinical Study Lead to drive the global execution of smaller or less complex clinical trials from design to closeout. You will manage timelines, budgets, and ensure study conduct aligns with SOPs and ICH/GCP.

The role covers internal studies and CRO engagements, with a focus on continuous improvement of CTM processes and reliable delivery across functional partners.