Clinical Study Manager Neurovascular (m/f/d)

1 month ago
Full-time
Mid Level
Project and Program Management
Penumbra

Penumbra

Penumbra Inc is a global healthcare company focused on innovating novel technologies to address challenging medical conditions in neuro and peripheral vascular markets. They design, develop, manufacture, and market medical devices for interventional th...

Health Care Providers & Services
1K-5K
Founded 2004

Description

  • Lead and manage international clinical studies from study start-up through close-out.
  • Coordinate investigator sites across Europe and internationally and provide operational support throughout the study lifecycle.
  • Manage study timelines, budgets, documentation, clinical systems, and trial dashboards.
  • Oversee external vendors, Investigator Meetings, and collaboration with Principal Investigators and Key Opinion Leaders.
  • Monitor study progress, identify risks, and drive timely issue resolution.
  • Support clinical data review, regulatory submissions, and study reporting.
  • Partner with cross-functional teams including Regulatory Affairs, R&D, Medical Affairs, Quality, Marketing, and Commercial.
  • Ensure compliance with ICH-GCP, QMS, and applicable regulatory requirements.
  • Contribute to continuous process improvements.

Requirements

  • Bachelor's degree in Life Sciences or a related scientific discipline.
  • 3–5+ years of clinical study or clinical project management experience in MedTech, medical devices, or pharmaceuticals.
  • 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, stakeholder management, and communication skills.
  • Proficiency with EDC systems, clinical trial management tools, and Microsoft Office.
  • Experience in Neurovascular, Cardiovascular, or another interventional medical device area is highly desirable.
  • Willingness to travel up to 20% across Europe and internationally.
  • Fluency in English; CV must be submitted in English.

Benefits

  • Annual fitness subsidy.
  • Comprehensive Employee Assistance Program.
  • Two weeks of paid Family Care Leave.
  • Paid time off on December 24th and 31st in addition to regular vacation days.
  • Supportive, diverse team environment focused on personal and professional growth.
  • Comprehensive accident insurance during business trips.

Interested in this position?

Apply directly on the company website

Apply Now

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