Clinical Study Manager Neurovascular (m/f/d)

Penumbra, Inc.; Deutschland; Remote; USD 110.000 - 160.000; Vollzeit

Benefits dieser Stelle

Fitness subsidy

Employee Assistance Program

Family Care Leave

Paid vacation days

Team that inspires

Accident Insurance

Zusammenfassung

Penumbra, Inc. in Alameda, CA is seeking an experienced Clinical Study Manager to lead international multicenter studies from start-up to close-out, ensuring on-time, on-budget delivery in compliance with ICH-GCP and regulatory requirements.

You will coordinate investigator sites across Europe and beyond, manage timelines and budgets, oversee vendors, and partner with Regulatory Affairs, R&D, Medical Affairs, Quality, Marketing, and Commercial teams to drive robust study execution.

Qualifikationen

• Bachelor's degree in Life Sciences or related field.
• 3–5+ years of clinical study or project management in MedTech/medical devices.
• Experience managing international multicenter studies and vendor oversight.
• Strong knowledge of ICH-GCP, study operations, and regulatory requirements.
• Experience in a global cross-functional matrix organization.
• Excellent PM, stakeholder management, and communication skills.
• Proficiency with EDC systems, trial management tools, and MS Office.
• Experience in Neurovascular or Cardiovascular interventional devices is desirable.
• Willing to travel up to 20% internationally.

Aufgaben

• 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.

Kenntnisse

Project management

Stakeholder management

Communication

Regulatory knowledge

Cross-functional collaboration

Travel readiness

Ausbildung

Bachelor's degree in Life Sciences

Tools

EDC systems

Clinical trial management tools

Microsoft Office

Jobbeschreibung

At Penumbra,innovation,teamwork, andinitiativeare more than values–they are the foundation of a workplace where every individual is encouraged to grow and make a real difference. We believe that the strength of our team lies in our diverse talents and shared passion for improving lives. Ifyou’relooking for a role where your contributions matter, we invite you to join a company that values both personal development and impactful work.

As a leading MedTech company,weprovidecutting-edgesolutions for conditions such as stroke, pulmonary embolism, deep vein thrombosis, and acute limb ischemia.Headquarteredin Alameda, California, Penumbra has over 4,500 employees worldwide and generated revenues of approximately $1.4 billion in 2025.

What is in it for you

• 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.

Main Responsibilities

• 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.

What we are looking for

• 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 inNeurovascular, Cardiovascular, or another interventional medical device area is highly desirable.
• Willingness to travel up to20% across Europe and internationally.

At Penumbra, we value your skills and qualificationsabove all else. We welcome candidates of any gender, ethnicity, religion, sexual orientation, or age. Ifyou'reskilled and a good match for our culture of collaboration, we want you on our team.

To learn more about Penumbra's commitment to being an equal opportunity employer, please take a look atour AAP-Policy-Statement.