Carmat aims to meet a major public health challenge related to cardiovascular diseases, namely heart failure, the leading cause of death in the world. More specifically, Carmat aims to provide a lasting solution to the treatment of terminal heart failure, a disease for which there are very few effective options today - the main one being heart transplants – and affecting at least 26 million people worldwide. Thanks to its unique design and physiological functions, the CARMAT total artificial heart could, subject to the success of ongoing clinical trials, save the lives of thousands of patients each year, without risk of rejection and preserving their quality of life.
Missions and Responsabilities
The mission consists in setting up and monitoring international clinical studies in pre-marked and in post-CE marked phases:
- Perform the selection of the investigational centers, the establishment, the follow-up and the closing of the clinical studies, in collaboration with the Clinical Study Manager.
- Ensure the monitoring and scientific, technical and regulatory quality of international studies according to ISO14155 and local regulatory requirements if necessary.
- Contribute to the administrative tasks required to set up and monitor clinical studies (e.g. collection of documents from the center required for regulatory procedures, archiving the Trial Master File sponsor and center)
- Conduct monitoring and co-monitoring visits to ensure the quality of data collected, source documents and the archiving of investigative documents
- Work in collaboration with the Clinical Study Manager to identify non-conformities in the conduct of the study, and contribute to the implementation of corrective or preventive actions if necessary
- To be in contact with the investigating doctors,
- Revise clinical procedures as needed
- Contribute to write (e.g. Trial Monitoring Plan) and implement study-specific clinical documents and monitoring tools
- Prepare centers, and contribute, to audits and inspections
- Write the visit reports in English
- Ensure the traceability of the gaps encountered according to a CAPA procedure
Knowledge & Skills
- Knowledge in Clinical Research and Medical Devices regulatory requirements : ISO 14155, European Regulation of DM 2017/745
- Knowledge of Good Clinical Practice (ICH-GCP)
- Knowledge in cardiology and cardiac surgery, will be appreciated
- Rigor, organization, autonomy
- Strength of proposal, especially with the investigative centers in the management of gaps.
- Written and verbal communication abilities
- Ability to analyze
- Effective Team working
- English
Educational requirements and experience
- Scientific degree BAC +3
- Experience in a CRA function of at least 3 years.
- Experience with FDA, ANSM inspections will be appreciated
Location
Vélizy-Villacoublay