Global Clinical Study Lead

Penumbra, Inc.; United States; Remote; USD 120,000 - 180,000; Full time

Benefits offered by this job

Fitness subsidy

Employee Assistance Program

Family Care Leave

Paid Time Off during holidays

Diverse, supportive team environment

Accident insurance on business trips

Job summary

Penumbra, Inc. seeks an experienced clinical project leader to drive international multicenter studies from start-up to close-out. You will coordinate sites across Europe and beyond, manage timelines and budgets, oversee vendors and meetings, and ensure regulatory compliance.

The role partners with Regulatory Affairs, R&D, Medical Affairs and Quality to deliver quality data. The ideal candidate holds a Life Sciences degree with 3–5+ years in MedTech or pharma clinical studies, and is comfortable

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 3–5+ years of clinical study or clinical project management experience within MedTech, medical devices, or the pharmaceutical industry.
• Hands-on experience managing international multicenter clinical studies, including site management, vendor oversight, and study execution.
• Strong knowledge of ICH-GCP, clinical study operations, and regulatory requirements.
• Experience working within a global, cross-functional matrix organization.
• Excellent project management and stakeholder management skills; strong communication abilities.
• Willingness to travel up to 20% across Europe and internationally.

Responsibilities

• Lead and manage international clinical studies from start-up through close-out, ensuring on-time, on-budget delivery in compliance with regulations.
• Coordinate investigator sites across Europe and internationally, providing operational support throughout the study lifecycle.
• Manage study timelines, budgets, documentation, clinical systems, and trial dashboards.
• Oversee external vendors, Investigator Meetings, and collaborations with PIs and KOLs.
• Monitor study progress, identify risks, and drive timely issue resolution for successful study execution.
• Support clinical data review, regulatory submissions, and study reporting.
• Partner with Regulatory Affairs, R&D, Medical Affairs, Quality, Marketing, and Commercial.
• Drive compliance with ICH-GCP, QMS, and applicable regulatory requirements while contributing to process improvements.

Skills

Project management

Stakeholder management

Communication skills

Cross-functional collaboration

Regulatory knowledge

Education

Bachelor's degree in Life Sciences

Tools

EDC systems

Clinical trial management tools

Microsoft Office

Job description

Penumbra, Inc. seeks an experienced clinical project leader to drive international multicenter studies from start-up to close-out. You will coordinate sites across Europe and beyond, manage timelines and budgets, oversee vendors and meetings, and ensure regulatory compliance.

The role partners with Regulatory Affairs, R&D, Medical Affairs and Quality to deliver quality data. The ideal candidate holds a Life Sciences degree with 3–5+ years in MedTech or pharma clinical studies, and is comfortable