MARCY-L'ETOILE
I'm now working as Clinical Scientist (from July 2015) at the Medical Affairs Department of bioMérieux (Marcy L'Etoile, France). I'm responsible for the design, implementation, monitoring, data analysis, reporting and completion of post-market clinical clinical trials on in vitro diagnostic products (especially high multiplex molecular biology based assay) or systems (high multiplex molecular biology, automatic blood culture, automatic immunoassays), in compliance with study objectives, quality system management, regulatory and ethical standards. From November 2012 to June 2015 I was working at the Clinical Affairs Department of bioMerieux and I was in charge to provide support and expertise to local Regulatory Affairs/Clinical Affairs team for the clinical studies in China (clinical trial design, clinical trial process, data management, statistical analysis, clinical trial protocol and clinical trial report), in compliance with study objectives, quality system management, local and international regulatory and ethical standards. I also had to ensure functional management and contribute to the development of the local Clinical Affairs team. Before to join the Clinical Affairs Department of bioMérieux, I worked for 5 years in Beijing, as the Lab Operations Manager of the Dr. Christophe Mérieux Laboratory (IPB-CAMS / Fondation Mérieux), leading a team of 11 scientists and technicians (Chinese people). The Dr. Christophe Mérieux Laboratory (CML) has been set up by IPB-CAMS and bioMérieux in March 2005, in order to identify new emerging pathogens. In January 2008, Fondation Mérieux has replaced bioMérieux to become the French partner of the project. By now, the discovery of new pathogens or variants and the surveillance of infectious diseases through collaborations with local, national or international partners, are currently the two main tasks of the CML (22 articles published or accepted in international revues, 1 PCT patent + extension registered). From 2005 to 2006, I have successfully conducted several trainings and technical evaluations as bioMérieux expert on H5N1; Hong Kong (WHO Flu reference laboratory / Dec 2005), India (National Institute of Virology / Feb 2006), Mainland China (Chinese CDC / Oct 2006). Before to join the team in Beijing, I was working in France as bioMérieux project leader on the development on the NucliSens EasyQ SARS-CoV TSR Reagents (product launched in January 2004). In May 2003 I came to Beijing during the SARS epidemic to work in BSL-3 laboratory, and to perform the evaluation of the molecular assay from bioMérieux. I started to work for bioMérieux as senior technician in the molecular biology R&D department in 1998 (Vénissieux, France). I has got a full time scientist position in the same R&D department in 2000. From 1998 to the beginning of 2003, I was involved in the development of a new HIV-1 genotyping assay using high density DNA chips (2 publications as first author and 1 as co-author). In 1998, I graduated a master of science degree in biological and medical engineering from Université C. Bernard Lyon I (France). Prior to join bioMérieux, I have got strong skills in molecular biology and biological analysis, working as student or technician in several laboratories: Unité Mixte CNRS/bioMérieux, Ecole Normale Supérieure de Lyon (France); Molecular Oncology Laboratory, Centre Léon Bérard, Lyon (France); Medical Analysis Laboratory, Hôpital d’Instruction des Armées Laveran, Marseille (France); Bacteriology Laboratory, Laboratoire Marcel Mérieux, Lyon (France).
Mes compétences :
Études cliniques
Management d'équipe
Chef de projet
International
Chine
Virologie
Bactériologie
Biologie moléculaire
Maladies infectieuses
