Clinical Investigation Expert l CRO Lead
Wiebe is part of the Clinical Affairs team, his area of expertise is in Clinical Strategy development, Clinical Evaluation, and Clinical Investigation.
His main activities are setting up international clinical operations and study management for all device classes under the Medical Device Regulation, with a focus on non-active high-risk devices.
The key expertise areas of Wiebe
- Prepare clinical strategies from a regulatory perspective.
- Clinical site assessment, qualification, selection, oversight, and close-out.
- Contract Research Organization management.
- Monitoring/auditing at (international) sites.
- Development of clinical study documentation and protocols.
- Study management of pre-and post-market trials.
- Risk and quality management during product development.
- Experience with multiple clinical management and QA systems, like CTMS, eTMF, LMS and QMS systems.
Wiebe about working at Qserve
“I strongly believe in the value of a practical and user-friendly approach while ensuring a high standard of quality. I look forward to helping customers bring their products to the market efficiently in an increasingly demanding regulatory environment. Does your medical device lack clinical data? We can help determine how to efficiently close those gaps and support your clinical investigations.”
Wiebe had an MSc in Immunology and a PhD. in Molecular biology.
Wiebe holds 5 years of experience in Medical Device industries, specifically in Ophthalmology and Orthopedics. In his last position, Wiebe was responsible for clinical affairs at a large orthopedic manufacturer. He designed, managed, analyzed and reviewed several clinical studies.
Wiebe performed, as CRA, and coordinated the Clinical Monitoring process in compliance with GCP to assess the safety and efficacy of medical devices. As an expert, Wiebe has experience in planning and preparing clinical trials and development and review of study protocols, ICFs, CRFs, EC/IRB and regulatory submission.
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