Global Clinical Study Lead

Regeneron Pharmaceuticals, Inc.; Armonk (NY); On-site; USD 129,000 - 210,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Manager, Clinical Study Lead to oversee global execution of clinical trials, ensuring timelines, budgets, and SOP adherence with ICH/GCP standards.

The role involves leading cross-functional teams, protocol input, site evaluation, and vendor management, with ~25% travel and on-site work in multiple locations. The position requires a Bachelor's degree and at least six years of experience, strong budget and vendor management skills, and proficiency in

Qualifications

• Bachelor’s degree and at least six years of relevant industry experience.
• Extensive budget management and vendor management experience.
• Strong proficiency with trial management systems and Microsoft Office.
• Experience in global clinical trial operations and protocol development.
• Knowledge of ICH/GCP and regulatory guidelines.

Responsibilities

• Lead the cross-functional study team for clinical study delivery on time and within budget.
• Provide operational input into protocol development and site selection.
• Oversee study documentation and systems (CTMS, TMF).
• Identify outsourcing needs and manage CRO/vendor relationships.
• Develop baseline budgets, timelines, and scope changes.
• Lead risk assessments, site activation, and patient recruitment strategies.
• Supervise CTM staff and drive process improvements.

Skills

Cross-functional leadership

Budget management

Vendor management

Trial management

ICH/GCP knowledge

Global operations

Project management

Education

Bachelor’s degree

Tools

Project

PowerPoint

Word

Excel

IVRS/IWRS

EDC

Job description

Regeneron Pharmaceuticals, Inc. is seeking a Manager, Clinical Study Lead to oversee global execution of clinical trials, ensuring timelines, budgets, and SOP adherence with ICH/GCP standards.

The role involves leading cross-functional teams, protocol input, site evaluation, and vendor management, with ~25% travel and on-site work in multiple locations. The position requires a Bachelor's degree and at least six years of experience, strong budget and vendor management skills, and proficiency in