Clinical Study Manager (Medical Devices)

Location: Eindhoven, Netherlands

Company

Technology consulting firm delivering solutions across information systems, digital, telecom, life sciences, and engineering.

What you will do

• Lead clinical studies for Class I and Class II medical devices from start-up through close-out.
• Develop, review, and maintain protocols, informed consent forms, study plans, monitoring plans, and clinical reports.
• Coordinate CRAs, CRCs, Data Management, Biostatistics, Regulatory Affairs, Quality Assurance, Medical Affairs, and R&D.
• Manage timelines, milestones, budgets, risks, sites, monitoring activities, and deliverables.
• Review clinical data, resolve study issues and protocol deviations, and support investigators and study sites.
• Prepare regulatory submission and audit documentation and maintain inspection readiness.

Requirements

• Master’s degree or PhD in life sciences, biomedical sciences, medicine, pharmacy, biomedical engineering, or another scientific discipline.
• At least 3 years of experience as a Clinical Study Manager in the medical device industry.
• Experience managing studies involving Class I and/or Class II medical devices.
• Strong knowledge of ISO 14155, ISO 13485, ICH-GCP, and EU MDR.
• Experience with clinical protocol writing, clinical study documentation, project management, and multidisciplinary stakeholder coordination.
• Strong communication skills in English and Dutch are required.

Culture & Benefits

• Equal-opportunity and inclusive working environment.
• International organization with 7,600 employees across more than 60 countries.
• Opportunities to work across life sciences and engineering projects.

Hiring process

• Brief virtual or phone call.
• Approximately three interviews, adjusted according to seniority.
• Potential case study, technical assessment, role play, or problem-solving exercise.