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Experiences

Current Experience

  • Clinical Project Manager
    Since August 2015

Past Experience

  • Clinical Project Manager
    August 2014 --- August 2015

  • Project Coordinator / Local Project Manager
    October 2013 --- June 2014
    • Act as local liaison between Client representatives (CRA, Sites monitors) and Covance Lab • Ensure the feasibility in collaboration with the Global Project Manager • Manage day-to-day local studies related activities (logistic, budget, planning) • Monitor, track and provide resolution to all local studies issues and complaints

  • Clinical Scientist apprentice
    September 2012 --- October 2013
    In charge of the clinical phase of product development and Clinical Affairs representative in the project team • Set-up of international clinical trials (Microbiology, Immuno-assay) for in vitro diagnostic medical devices • Draft of clinical trial protocols, plan and final performances reports • Management of clinical trials: sites selection, set-up, monitoring and close-out visits

  • Packaging Technician
    October 2011 --- October 2013
    • Vaccine vials packaging before their cryopreservation according to GMP (good manufacturing practices) • Quality control of vials integrity • Training of newcomers

  • Clinical Research Associate Trainee
    May 2012 --- August 2012
    Set-up and monitoring of clinical trials (Phase I, II, III) on retinal disease (GATE, VIVID, ESBA, RETAIN study) • Raw data entry, validation of CRF/eCRF and queries management • Follow-up, assistance and convocation of patients • Creation of an informatics database facilitating management of patients follow-up • Communication with sponsor, CRA and other study stakeholders

  • Quality control technician
    July 2011 --- August 2011
    • Check on conformity of each batches of raw material • Physicochemical measurement on raw material batches • Acceptance or rejection of batches according to quality norms

  • Laboratory Technician
    July 2010 --- August 2010
    • Execution of biologic tests with different reagents produced by bioMérieux according to GLP • Statistical analysis of biological data, in order to put forward a control protocol for improve current control techniques • Investigation with TNC (Non Compliance Processing) team to find non compliances origins

Knowledge

LinkedIn Assessment :
Clinical trialsClinical DevelopmentClinical Data ManagementClinical researchMedidataGCPPharmaceutical IndustryBiotechnologyGMPSOPLifesciencesFDAVaccinesInfectious diseasesGood Laboratory Practice (GLP)SAP

Education

  • Master 2 Ingénierie de la santé in Management de projet et opérations cliniques from Université Montpellier I in 2013
  • Master 1 in Ingénierie pour la santé et le médicament from Institut de pharmacie industrielle de Lyon (IPIL) in 2012
  • Licence de Biologie spécialité Physiologie in from Université Claude Bernard (Lyon I) in 2011

Area / Region

Lyon, France

Others

Driving License
  • Yes