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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

  • Local Project Manager
    Since May 2016
    • Study protocol translation • Budget coordination • Regulatory submission (CCTIRS, CNIL, CNOM) • Site visit initiation • Site visit report validation • Partners/ Service provider coordination (Investigators, CRO...)

Past Experience

  • Clinical Project Leader
    May 2015 --- May 2016
    Documents writing - 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

France

Others

Driving License
  • Yes