Clinical Study Manager

Job Summary

The Clinical Study Manager leads international multicenter clinical trials from startup to close-out. This manager coordinates investigator sites across Europe, manages trial budgets and timelines, oversees CROs and external vendors, ensures ICH-GCP compliance, collaborates with Principal Investigators (PIs) and Key Opinion Leaders (KOLs), and partners with Regulatory Affairs, R&D, and Quality teams.

Key Roles & Operational Responsibilities

1. International Trial Management & Operational Execution

• End-to-End Lifecycle: Lead, plan, and execute international clinical studies from protocol initiation through site setup, recruitment, data lock, and study close-out.
• Site & Vendor Oversight: Coordinate investigator sites across Europe and international locations; supervise CROs, central labs, and external vendors to ensure deliverables meet contractual timelines and budget expectations.
• KOL & PI Engagement: Drive collaboration with Principal Investigators (PIs) and Key Opinion Leaders (KOLs), organizing Investigator Meetings and supporting trial governance.

2. Timeline, Budget & Data Management

• Trial Dashboards: Track and manage trial timelines, operational budgets, clinical documentation, and electronic data capture (EDC) systems.
• Risk Mitigation & Clinical Data: Monitor trial progress, identify study risks, lead root-cause problem solving, and support clinical data review, regulatory submissions, and final study reporting.

3. Governance, Quality & Cross-Functional Alignment

• ICH-GCP Compliance: Ensure all trial operations strictly adhere to ICH-GCP, Quality Management Systems (QMS), and international regulatory requirements.
• Matrix Collaboration: Partner seamlessly with cross-functional internal units including Regulatory Affairs, R&D, Medical Affairs, Quality Assurance, Marketing, and Commercial teams.

Foundational Capabilities & Prerequisites

Required Technical Profile & Qualifications

• Academic Baseline: Bachelor’s degree in Life Sciences, Biomedical Engineering, Nursing, or a related scientific discipline.
• Clinical Management Experience: 3–5+ years of dedicated clinical study or clinical project management experience within the MedTech, medical device, or pharmaceutical industry.
• Multicenter Trial Mastery: Hands-on experience directing international, multicenter clinical studies, including site management, vendor oversight, and regulatory filings.
• Regulatory & Quality Standards: In-depth knowledge of ICH-GCP guidelines, clinical trial operations, and global medical device regulatory frameworks.
• Digital Systems: Proficiency with EDC platforms, Clinical Trial Management Systems (CTMS), and Microsoft Office.
• Language Proficiency: Professional fluency in spoken and written English (all CVs and interview processes are conducted in English).
• Mobility: Willingness and capability to travel up to 20% across Europe and internationally.

Desirable Attributes

• Specific clinical trial experience within Neurovascular, Cardiovascular, or other interventional medical device therapeutic areas.
• Proven success navigating complex matrix organizations and communicating effectively across cultures.

What Penumbra Offers

• Wellness & Active Lifestyle: Annual fitness subsidy to support personal health and wellness.
• Family Care & Leave: Comprehensive Employee Assistance Program (EAP) and two weeks of paid Family Care Leave for family health needs or bereavement.
• Paid Time Off: Standard vacation allowance plus dedicated paid company holidays on December 24th and 31st.
• Travel Safety: Comprehensive accident insurance covering all global business travel.
• Inclusive Culture: Open-minded, collaborative team environment dedicated to personal and professional development.

Skills Required:

• Health / Medical