- Lead and manage end-to-end clinical studies for coronary and peripheral devices, including feasibility, pivotal, and post-market trials.
- Develop study protocols, case report forms (CRFs), monitoring plans, risk management plans, and other trial documentation.
- Oversee study start-up activities including site selection, contracts, budgets, and ethics submissions.
- Ensure timely trial progress, enrollment, monitoring, data collection, and reporting.
- Manage and provide direction to CROs, core labs (e.g., angiographic imaging analysis labs), and clinical warehouses handling device logistics.
- Establish KPIs, track vendor performance, and ensure adherence to timelines, quality standards, and budgets.
- Coordinate with supply chain and warehouse teams for clinical device distribution, inventory tracking, and returns.
- Supervise clinical research associates (CRAs), trial coordinators, and other study support staff.
- Provide coaching, performance management, and workload prioritization.
- Foster a culture of quality, collaboration, and continuous improvement.
- Ensure all clinical activities comply with ICH-GCP, ISO 14155, EU MDR (2017/745), and local regulations (e.g., BfArM, ANSM, MHRA, AEMPS).
- Support preparation of regulatory submissions, technical documentation, and notified body audits.
- Manage inspection readiness and respond to regulatory queries regarding clinical data.
- Contribute to clinical strategy, study design, and evidence-generation plans for coronary and peripheral devices.
- Collaborate with R&D, marketing, medical affairs, quality, and regulatory teams to support product development and post-market surveillance.
- Present clinical trial updates, risk assessments, and metrics to leadership.
- Create and manage clinical study budgets.
- Track expenses and forecast study-related financial needs.
- Ensure timely delivery of milestones and proactively resolve operational challenges.
- Master's degree or higher in Life Sciences, Nursing, Biomedical Engineering, or related field.
- Preferred: Master's degree (MSc/MPH) in Clinical Research, Biomedical Sciences, or Healthcare Management.
- 10+ years of experience in clinical research, with at least 3+ years managing medical device trials, ideally in cardiovascular (coronary or peripheral).
- Demonstrated experience overseeing CROs, core labs, and external vendors.
- Strong understanding of EU MDR, ISO 14155, ICH-GCP, and European clinical trial regulations.
- Prior experience managing multinational clinical studies in Europe.
- Experience leading clinical teams and managing complex operational structures.
- Strong project leadership, organization, and time-management abilities.
- Excellent vendor management and negotiation skills.
- Ability to interpret clinical data and manage clinical documentation.
- Effective communication skills across diverse teams and cultures.
- Ability to travel (20–40% depending on business needs).
- Experience with cardiovascular, endovascular, coronary stents, balloons, atherectomy, or related devices.
- Prior involvement in CE-marking activities or clinical evidence generation under EU MDR.
- Experience with EDC, CTMS, eTMF systems.
- Fluency in multiple European languages is an advantage.
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Clinical Manager – Europe - Île-de-France - Concept Medical
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Description
Department: Clinical Trials
Role Summary
The Clinical Manager – Europe is responsible for planning, executing, and overseeing clinical trials for coronary and peripheral vascular medical devices across the European region. This role provides strategic and operational leadership to internal teams and external vendors (CROs, core laboratories, investigational sites, and distribution warehouses). The manager ensures that all clinical programs are conducted in compliance with ISO 14155, ICH-GCP, EU MDR, local country regulations, and internal company standards.
Key Responsibilities
1. Clinical Trial Management
2. Vendor Oversight
3. Team Leadership
4. Regulatory & Quality Compliance
5. Clinical Strategy & Cross-Functional Collaboration
6. Budget & Timeline Management
Required Qualifications & Experience
Education
Professional Experience
Key Skills
Preferred Attributes
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