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Marine CROUZILLE (GROBOZ)

Lyon

En résumé

Mes compétences :
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PLANISWARE5
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Secourisme - Protection Civile

Entreprises

  • Sanofi Pasteur - Clinical Trial Manager

    Lyon 2016 - 2017 Projects
    Clinical Trials – International (Poland and Russia)
    • Meningococcal Vaccine
    o Observational Study in Russia, prospective safety study
    o Phase III Study: Immunogenicity & Safety Study in Europe

    • Pediatric combined vaccine – Immunogenicity & Safety (registration) Study in Russia and Poland

    Responsibilities
    • Feasability/Site selection,
    • Submission to HA/EC preparation,
    • Coordination of sites, CROs & CRAs,
    • Management of vaccines & supplies,
    • Strong interaction with other departments, Study follow-up, eTMF and eCRF use
  • Sanofi Pasteur - Clinical Program Manager

    Lyon 2015 - 2016 Projects:
    Clinical Trials – International (Asia, Latin America)
    • Dengue Project – Exploratory Phase (Epidemiology/Thailand), Phase II (Immunogenicity & Safety/Brazil)
    • Clostridium Difficile Project – Phase III (Efficacy, Immunogenicity & Safety/Asia)

    Responsibilities:
    • Coordination of clinical trials and study-related activities (monitoring, data management,
    regulatory affairs, biostatistics);
    • Management of negotiation and budget (AED, Investigator agreement, fee negotiation and payment of the investigators/centers);
    • Management of planning of the studies, communication of timelines and studies progress
    • Organization and chairing of clinical team meetings
  • Sanofi Pasteur - Clinical Project Manager V.I.E (Singapour)

    Lyon 2013 - 2015 Management and coordination of the projects:
    • Epidemiological Studies – International (Asian region)
    o Prospective dengue incidence study in India, involving 14,000 subjects / 4 sites
    o Dengue Seroprevalence Study in Indonesia – 3200 Subjects / 1 main site - 30 satellite sites
    o Incidence Study in Dengue-Endemic region in Asia and Latin America – Coordination for activities in Asia – 5 sites in Malaysia
    o Vaccine safety and effectiveness studies to prepare for dengue vaccine launch in Malaysia and Philippines - 2400 Subjects / 7 sites
    • Clinical Trials – International (Vietnam) - Registration of Meningococcal Vaccine in Vietnam – 200 Subjects
    • Investigator Sponsored Studies – International (Asian Region) - Working on several projects (Flu, Clostridium Difficile, Meningococcal, Pertusis..)
  • Sanofi Pasteur - Clinical Program Manager - Apprentice

    Lyon 2012 - 2013 Projects:
    Clinical Trials – International (Asia, US)
    • Dengue Project – Phase I (Tolerance/Philippines), Phase II (Immunogenicity & tolerance/Singapore + two trials in collaboration with the US Army), Phase III (follow-up of subjects included in efficacy trial/Thailand)
    • Support for Quadrivalent Flu Vaccine trial

    Responsabilities:
    • Participation at coordination of clinical trials within a project
    • Management of budget of the studies (AED, Investigator agreement, fee negotiation and payment of the investigators/centers)
    • Management of planning of the studies, communication of timelines and studies progress
    • Coordination of study-related activities: monitoring, regulatory affairs, data management and biostatistics
    • Organization and chairing of clinical team meetings
  • ICM, Institut du Cancer de Montpellier - Attachée de Recherche Clinique - Stagiaire

    montpellier 2012 - 2012 - Management d'une Etude de Phase II sur le cancer du Rectum
    - Management d'une Etude de Phase II sur la chirurgie conservative dans le cancer du sein (oncoplastie)
    - Suivi de patients
    - Mise en place d'une Etude
  • ICM, Institut du Cancer de Montpellier - Attachée de Recherche Clinique - Stagiaire

    montpellier 2012 - 2012 - Particiapation en tant qu'Attachée de Recherche Clinique sur une étude de Phase I en oncologie
    - Suivi de patients
  • Institute of Technology Tallaght (Dublin, Irlande) - Stagiaire recherche fondamentale

    2011 - 2011 - Suivi de protocoles expérimentaux
    - Synthèse de nouveaux produits (polymères)
    - Utilisation des méthodes de caractérisation électrochimique
  • Inserm - Attachée de Recherche clinique - chercheur (stagiaire)

    PARIS 13 2010 - 2010 - Participation en tant qu'ARC à une étude clinique sur la Dystrophie Facio-Scapulo Humérale
    - Travail en laboratoire, suivi de protocoles expérimentaux

Formations

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