Clinical Study Manager (Medical Devices)

TL;DR

Clinical Study Manager (Medical Devices): Planning, coordination, and execution of clinical studies for Class I and II medical devices with an accent on regulatory compliance and operational oversight. Focus on developing clinical protocols, managing cross-functional teams, and ensuring adherence to ISO 14155, ISO 13485, and MDR standards.

Company

Independent technology consulting firm providing guidance and solutions across Information Systems, Telecom, Life Sciences, and Engineering for over 1000 clients globally.

What you will do

• Lead the operational management of clinical studies from start-up through close-out.
• Develop and maintain clinical study documentation, including protocols, informed consent forms, and clinical reports.
• Ensure all studies comply with ISO 14155, ISO 13485, MDR, GCP, and internal quality procedures.
• Coordinate cross-functional teams, including CRAs, CRCs, Data Management, Regulatory Affairs, and R&D.
• Manage study timelines, budgets, risks, and milestones.
• Prepare documentation for regulatory submissions and support internal and external audits.

Requirements

• Master's degree or PhD in Life Sciences, Medicine, Pharmacy, Biomedical Engineering, or a related scientific discipline.
• Minimum 3 years of experience as a Clinical Study Manager within the medical device industry.
• Proven experience managing clinical studies for Class I and/or Class II Medical Devices.
• Strong knowledge of ISO 14155, ISO 13485, ICH-GCP, and EU MDR.
• Experience in clinical protocol writing and multidisciplinary team coordination.
• Strong communication skills in English and Dutch.

Culture & Benefits

• Inclusive and diverse equal-opportunity workplace.
• Opportunity to work within a massive international network of 7,600 people across 60 countries.
• Professional growth and development as a steppingstone to complex global projects.

Hiring process

• Initial brief virtual or phone conversation to discuss motivations and fit.
• Series of interviews (average of 3) with line managers and future colleagues.
• Case study or technical assessment depending on the specific role requirements.