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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 science)" rel="nofollow">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

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