Clinical Study Manager Neurovascular
New
P
PenumbraMedTech
EuropeContractMiddle
Salary not disclosed
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Job Details
- Experience
- 3–5+ years
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.
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.
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