Senior Clinical Research Associate (CRA) – Medical Devices (F/M/X)

Job description As a Senior CRA, you will play a key role in the successful execution of clinical investigations for medical devices. You will oversee site management activities, ensure regulatory compliance, and support clinical project teams across various client engagements. Your project experience will allow you to contribute beyond monitoring by supporting study planning, operational excellence, and stakeholder management. Key Responsibilities Perform site feasibility, qualification, initiation, routine monitoring, and close\-out visits. Ensure clinical investigations are conducted in accordance with ISO 14155, ICH\-GCP, MDR (EU 2017/745\), applicable local regulations, and study protocols. Monitor site performance, patient safety, protocol compliance, and data quality. Build and maintain strong relationships with investigators, clinical sites, sponsors, and cross\-functional teams. Identify operational risks and proactively drive issue resolution. Support Clinical Project Managers with study planning, timelines, and project execution. Review essential documents and ensure inspection readiness throughout the study lifecycle. Contribute to process improvements and share best practices across projects. Mentor junior CRAs where appropriate. Your Profile Master's degree or higher in Life Sciences, Biomedical Sciences, Biomedical Engineering, Pharmacy, Medicine, or another relevant scientific discipline. At least 5 years of experience as a Clinical Research Associate, preferably within the Medical Device industry. Demonstrated experience supporting clinical projects beyond routine monitoring activities. Strong knowledge of ISO 14155, MDR (EU 2017/745\), ICH\-GCP, and applicable regulatory requirements. Experience working in multidisciplinary and international project teams. Excellent stakeholder management and communication skills. Fluent in English and Dutch. Willingness to travel throughout the Ne