1 месяц назад
Clinical Research Associate (Medical Devices)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Research Associate (Medical Devices) (Clinical Investigations): Supporting the planning, execution, monitoring, and close-out of clinical investigations for Class I–III medical devices with an accent on GCP, ISO 14155, EU MDR, and clinical documentation. Focus on coordinating clinical sites and stakeholders, following up on protocol deviations and safety events, maintaining TMF/ISF records, and supporting audits and inspections.
Location: Eindhoven, Netherlands
Company
is an independent technology consulting firm providing solutions across Information System & Digital, Telecom, Life Sciences, and Engineering.
What you will do
- Plan, execute, monitor, and close out clinical investigations for Class I, Class II, and Class III medical devices.
- Perform site selection, qualification, initiation, monitoring, follow-up, and close-out activities.
- Maintain and review Trial Master File and Investigator Site File documentation.
- Monitor clinical data and documentation, identify protocol deviations and non-compliances, and follow up on study issues.
- Coordinate with investigators, study coordinators, sponsors, medical experts, and cross-functional project teams.
- Support safety-event reporting, clinical documentation, audits, inspections, and regular study status updates.
Requirements
- Bachelor’s or Master’s degree in Life Sciences, Biomedical Sciences, Nursing, Pharmacy, Medicine, or a related discipline.
- Proven professional experience as a Clinical Research Associate in the medical device industry.
- Experience with clinical investigations involving Class I, Class II, and/or Class III medical devices.
- Strong knowledge of GCP and ISO 14155, with an understanding of the EU Medical Device Regulation and clinical evaluation framework.
- Experience with clinical trial documentation, TMF/ISF, monitoring activities, and study processes from start-up through close-out.
- Professional proficiency in English and willingness to travel to clinical sites when required.
Nice to have
- Dutch language skills.
Culture & Benefits
- Work on multiple medical device projects and technologies for different clients.
- Exposure to Class I–III devices and different stages of clinical development.
- Training, knowledge-sharing, and professional development opportunities.
- International and multidisciplinary working environment.
- Competitive salary and benefits package aligned with experience.
Hiring process
- Brief virtual or phone call.
- Approximately three interviews, depending on seniority.
- Potential case study, role play, technical assessment, or problem-solving exercise.
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