Contexte The Lausanne University Hospital CHUV is one in five university hospitals in Switzerland, and the only one in the French-speaking part of the country carrying out DBS implantations for Parkinsonian conditions, with more than 50 cases per year. Academically, it is linked to the Faculty of Biology and Medicine of the University of Lausanne (UNIL) and it holds close ties to the Swiss Federal Institute of Technology in Lausanne (EPFL).
At CHUV, we perform early feasibility clinical trials (C2) with implantable neurotechnologies (Class III medical device) to restore neurological functions in people with Spinal Cord Injury, Parkinson’s Disease, or Stroke.
Mission
CHUV is seeking for a Clinical and Regulatory Research Specialist to lead the preparation of regulatory submissions and support the clinical team in the management of clinical trials. The specialist will contribute to several studies in parallel and be involved in all phases of a clinical trial, from study start-up through to study completion.
Prepare clinical documentation for submission to the ethics committee and the competent authority: Write clinical trial amendments and documentation for submission to Swissmedic and CER-VD.
Support writing and review of medical device technical files, such as risk management activities, requirements, testing plan and reports. Support the conduct of ongoing clinical trials: Ensure trials are conducted according to the protocol.
Manage case report forms completeness.
Perform Trial Master Files & Investigator Site Files completeness checks.
Perform data completeness checks prior monitoring visit. Profil Master degree in biomedical engineering or similar.
Minimum 2 years of experience in clinical operations/ regulatory field.
Excellent rigor and attention to detail.
Solid understanding of clinical trial processes, GCP, and regulatory req