This is what you will be doing at Qserve:
As a Clinical Study Manager at our CRO you lead the planning, setup and execution of clinical investigations for medical devices and in-vitro diagnostic devices. In close collaboration with the Sponsor, you develop the necessary study documents, secure ethics approval and competent authority approval, and manage the study from start-up to close-out. You lead a small team of in-house and contract CRA’s, conduct co-monitoring visits, site audits, and GCP training sessions. Most studies are in Europe but you sometimes step in when help is needed with a study in the US, China or other region. This is a broad role where you are expected to develop a good knowledge of, and hands-on experience with a large variety of devices and study designs in all stages of clinical development. When you are not working in clinical operations, you participate in other clinical projects including the writing of study protocols, post-market clinical follow-up plans and clinical evaluations.