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Clinical Study Manager, Neurovascular
Penumbra, Inc.Leading Clinical Study Manager role in a MedTech company, managing multicenter clinical studies across Europe. Seeking candidates with clinical project management experience and strong knowledge of regulatory requirements.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing international clinical studies, ensuring compliance with ICH-GCP and regulatory requirements while effectively coordinating cross-functional teams and external vendors. Proficient in project management and clinical data review, with a strong focus on delivering studies on time and within budget.
Highest-signal resume keywords
Clinical Study ManagementICH-GCP ComplianceProject ManagementStakeholder ManagementEDC Systems Proficiency
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Study OperationsRegulatory SubmissionsStudy ExecutionVendor OversightBudget ManagementTimeline ManagementDocumentation ManagementClinical Data ReviewTrial DashboardsSite Management
Soft Skills
Communication SkillsProblem-Solving SkillsCollaboration SkillsStakeholder Engagement
Tools & Technologies
Clinical Trial Management ToolsEDC SystemsMicrosoft Office
Industry Keywords
MedTechMedical DevicesPharmaceutical IndustryNeurovascularCardiovascularInternational Clinical StudiesCross-Functional TeamsQuality Management SystemsContinuous Process Improvements
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- 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.