Clinical Study Manager, Neurovascular

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Penumbra, Inc.

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2004

⚕️ Healthcare Insurance

🧬 Biotechnology

Healthcare Insurance • Biotechnology • Medical Devices

Penumbra, Inc. is a global healthcare company focused on developing innovative technologies to help patients worldwide. Specializing in the production of medical devices for neuro and vascular conditions, Penumbra offers products such as thrombectomy devices, embolization catheters, and MRI-compatible systems. The company is dedicated to advancing patient care with next-generation software solutions like Lightning Flash 2. 0, designed for the rapid removal of blood clots and treatment of pulmonary embolism. Penumbra is committed to improving outcomes for conditions like stroke, brain aneurysm, and heart attack, supported by clinical evidence and investor growth strategies.

📋 Description

• Lead and manage international clinical studies from study start-up through close-out, ensuring delivery on time, within budget, and in compliance with applicable 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 Principal Investigators (PIs) and Key Opinion Leaders (KOLs). • Monitor study progress, identify risks, and drive timely issue resolution to ensure successful study execution. • 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. • Drive compliance with ICH-GCP, QMS, and applicable regulatory requirements while contributing 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 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, 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.

🏖️ Benefits

• Stay Active - Enjoy an annual fitness subsidy to support your healthy lifestyle. • Support & Well-Being - Benefit from our comprehensive Employee Assistance Program, providing guidance and support in times of need. • Family First - Receive two weeks of paid Family Care Leave to support a sick family member or in the case of bereavement. • Vacation Time - In addition to your regular vacation days, enjoy paid time off on December 24th and 31st. • A Team That Inspires - Work alongside a diverse, open-minded, and supportive team that encourages personal and professional growth. • Accident Insurance - Stay protected with comprehensive accident insurance during all business trips.