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Summary

- local Project Manager - ongoing excelya, on behalf of bayer Pharmaceuticals - Clinical Project Leader - 1 year soladis clinical studies (formerly orgamétrie) - Clinical Research Coordinator - 1 year institut pasteur - clinical ressearch coodinator/ CRA - 1 year institut pasteur of madagascar - Clinical Research Associate - 6 months institut universitaire en santé mentale de québec - Clinical Research Associate - 5 months chu angers service de réanimation - Clinical Research Associate - 4 months chu grenoble service de cardiologie spécialisations : bpc, ich rédaction de protocole Élaboration des bases de données analyse statistique monitoring

Experiences

Current Experience

  • Project Manager

    Belgium
    Since October 2017

    Project Manager at syneos Health on behalf of bristol-myers squibb

    study Phase II/iii
    Clinical studies oversight
    management of providers
    ensure Compliance with study timelines

    Project Manager at Syneos Health on behalf of Bristol-Myers Squibb

    Study phase II/III
    Clinical Studies oversight
    Management of providers
    Ensure compliance with study timelines

Past Experience

  • Local Project Manager Lille, France

    May 2016 --- October 2017

    • study science)" rel="nofollow">Protocol Translation • budget coordination • regulatory submission (cctirs, cnil, cnom) • site visit initiation • site visit report Validation • partners/ service provider coordination (investigators, CRO...)

  • Clinical Project Leader

    May 2015 --- May 2016
    documents writing - science)" rel="nofollow">Protocol - crf - information consent form regulatory submissions - cctirs, cnil - cpp, ansm - cnom study set-up - printing management - kick off meeting management of centers - contracts/agreements implementation and follow up - CRA management - monitoring visit follow-up and report Validation - writing of monitoring plan study follow-up - inclusions follow-up - progress reports - timelines - budget

  • Clinical Research Coordinator

    May 2014 --- April 2015
    writing study documents project coordination regulatory submission follow-up and monitoring visits

  • Clinical Research Coordinator

    January 2013 --- December 2013
    development and implementation of the archive plan creation and establishment of quality procedures follow-up and monitoring visits development of a Good Clinical Practice Training

  • Clinical Research Associate (CRA)

    March 2012 --- September 2012
    rédaction du protocole d'étude Élaboration de la feuille de recueil création de la base de données analyse des résultats

  • Clinical Research Associate (CRA)

    October 2011 --- March 2012
    - création des classeurs investigateurs - rédaction du crf - réunion de mise en place - monitoring

  • Clinical Research Associate (CRA)

    March 2011 --- June 2011
    - prise de rendez-vous pour la visite d'inclusion. - inclusion des patients éligibles à l'étude (30 patients inclus). - suivi des patients. - remplissage du crf. - Élaboration de la base de données patient.

Personality

Self Assessment :
AdaptabilityAnalytical thinkingCollaborationCommunicativeCoordinationCuriosityIndependenceOptimismOrganizationSociability

Knowledge

LinkedIn Assessment :
Clinical researchClinical monitoringGCPsICH guidelinesSPSSAdobe AcrobatClinical trialsPharmaceuticalsStataLotus NotesMicrosoft Office 2007OpenClinicagestion de projetANSM

Skills and Expertise

Self Assessment :
project managementSubmit regulatory applicationsmanaging a small team

Education

  • Master in Recherche clinique from Institut Supérieur de la Santé et des Bioproduits d'Angers in 2012
  • Master's degree in Biotechnology from Université Joseph Fourier (Grenoble I) in 2011

Training and Certification

  • M.S. Project Management of clinical trial in 2012 Training
  • M.S. Health Engineering and Medicine - Biotechnology in 2011 Training
  • B.S. Biology in 2010 Training
  • Languages

    BrightOwl Assessment:
    Self Assessment:
    French
    Native
    English
    Professional Proficiency

Work Preferences

  • Notice Period:
    12 weeks
  • Positions I am interested in:
    Clinical Trial Manager (CTM) Clinical Project Manager (CPM) Clinical Project Leader
  • Positions I am NOT interested in:
    Clinical Research Associate (CRA) Clinical Trial Assistant (CTA)
  • Work From Home:
    Yes, 0 to 3 days per week
  • Work Regime:
    Permanent position :    100% FTE
  • International:
    Yes

Area / Region

Belgium

Others

Driving License
  • Yes

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