CLINICAL TRIAL SPECIALIST

1 Year contract - CHUV Lausanne

NeuroRestore is a research and innovation center spanning EPFL and CHUV that develops bioengineering strategies involving neurosurgical interventions to restore neurological functions. Our innovative treatments result from rigorous preclinical studies that have been conducted during the last 15 years in rodent and non-human primate models.

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.

JOB DESCRIPTION and RESPONSABILITIES

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.

(A)  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.

 

(B)   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.

PROFILE

  • 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 requirements.

  • Fluency in English.

  • Ability to work independently along with a multidisciplinary team on a large portfolio of clinical trials.

     

    Nice to have

  • Prior experience in medical devices clinical trials strongly preferred.

  • Experience with medical device risk management processes (ISO 14971)

  • Interest in neuromodulation therapies.

Please submit the following documents:

  • A CV outlining your educational background and relevant experience.

  • A cover letter.

  • Applications should be sent to lea.bole-feysot@chuv.ch

INFO CHUV

Working Place: CHUV, Lausanne

Type of contract : 1 year contract

Occupancy rate: 80-100%

Preferred date of start: May

Contact: lea.bole-feysot@chuv.ch

Matthieu Gautier