Clinical Project Manager
Since May 2022 Caesar has joined the Qserve Group as Clinical Project Manager in the Qserve CRO team. Caesar has close to 7 years of experience in Clinical Investigations, of which 4,5 years with medical devices.
As Clinical Project Manager, Caesar will be responsible for the planning, setup and execution of clinical investigations for medical devices. Caesar is based in the Netherlands.
Caesar about working at Qserve
Working at Qserve is to me an opportunity to be involved in the development of novel state-of the art technologies, to innovate and improve the biomedical field together with the most knowledgeable and skilled people in the field. I find medical devices fascinating, because they often possess ingenious technology intended for a concrete medical purpose. I enjoy the broad dynamics associated with running clinical investigations. They require team efforts between colleagues, manufacturers and hospital staff, posing challenges on a cross-divisional level as much now as ever. And as a Clinical Project Manager one will be in the middle of it all.
Caesar has close to 7 years of experience in Clinical Investigations, of which 4,5 years with medical devices. After 5 years of translational research on stem cell therapy, Caesar started working as a CRA at a CRO specialized in oncology. He later moved to another CRA position supporting mostly investigator-initiated trials. Caesar subsequently worked as a Clinical Project Leader on medical devices in the cardiovascular field. Caesar joined Qserve in May 2022.
Caesar has mainly developed expertise in high risk implantable medical devices at the pre- and post-market phase. He has experience in the approval process of clinical investigations under the MDR.
The key expertise areas of Caesar:
- Providing regulatory submission strategy for clinical investigations
- Liaising with Ethics Committees, the Competent Authority and Key Opinion Leaders
- Clinical Investigation documentation development and review (e.g. Clinical Investigation Plan, Informed Consent Form, Monitoring Plan)
- Supporting Clinical Trial Agreement negotiations
- Cross-divisional Project Management and clinical trial oversight
- Performing Site Qualification visits, Initiation visits, Routine Monitoring visits, Close-out visits, vendor audits.
- Knowledge of ICH-GCP and ISO14155 guidelines
- Scientific inquiry and providing scientific input
Learn more about Qserve CRO