Clinical Study Manager — Medical Devices (ISO/GCP)

Amaris Consulting; Eindhoven; On-site; EUR 70,000 - 100,000; Full time

Job summary

Amaris Consulting is seeking a Clinical Study Manager in the Netherlands to oversee planning, coordination, execution, and oversight of clinical studies for Class I and II medical devices. You will ensure regulatory compliance, quality standards, and effective collaboration across CRAs, CRCs, Data Management, Regulatory Affairs, QA, and R&D.

Applications require a Master’s or PhD in Life Sciences or related fields and at least 3 years of experience in clinical study management within the medical

Qualifications

• Master’s degree or PhD in Life Sciences, Biomedical Sciences, Medicine, Pharmacy, or related field.
• Minimum 3 years of experience as a Clinical Study Manager in the medical device industry.
• Experience with Class I and Class II medical devices and regulatory standards (ISO 14155, ISO 13485, MDR, GCP).

Responsibilities

• Lead end-to-end management of clinical studies from start-up to close-out.
• Develop and maintain study documentation including protocols and reports.
• Ensure compliance with ISO 14155, ISO 13485, MDR and GCP.
• Coordinate multidisciplinary teams–CRAs, CRCs, Data Management, Regulatory Affairs, QA, Medical Affairs, R&D.
• Manage timelines, milestones, budgets, risks, and deliverables.
• Oversee site selection, initiation, monitoring, and study close-out with CRAs.
• Guide investigators on protocol requirements and regulatory compliance.
• Review data quality and resolve protocol deviations; drive process improvements.
• Prepare regulatory submission/inspection documentation and support audits.

Skills

Clinical study management

Project management

Regulatory compliance

Stakeholder management

Cross-functional collaboration

English and Dutch

Education

Master’s or PhD in Life Sciences or related

Tools

ISO 14155

ISO 13485

ICH‑GCP

MDR

Job description

Amaris Consulting is seeking a Clinical Study Manager in the Netherlands to oversee planning, coordination, execution, and oversight of clinical studies for Class I and II medical devices. You will ensure regulatory compliance, quality standards, and effective collaboration across CRAs, CRCs, Data Management, Regulatory Affairs, QA, and R&D.

Applications require a Master’s or PhD in Life Sciences or related fields and at least 3 years of experience in clinical study management within the medical