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Elisa BAELEN

Durham

En résumé

Mes compétences :
clinical trials
GCP
ICH
Management
Microsoft Project
Microsoft Project Management
Gestion de projet

Entreprises

  • Quintiles - Senior Clinical Project manager

    Durham 2015 - maintenant
  • Quintiles - Clinical Project Manager

    Durham 2013 - 2015
  • Actelion - Clinical Project Manager

    Paris 2010 - 2013
  • Bristol Myers Squibb (Mead Johnson division) - Chef de projet etudes cliniques

    2008 - 2010 • CLINICAL TRIALS MANAGER - Phase IV / Post-marketing studies
    - Design of the Protocol (closely with Medical Director), CRFs, ICF
    - Study feasibility assessment
    - Budget and timing evaluation and follow-up
    - Submission and preparation of documents to authorities (IRB/IEC)
    - Sites selection and investigators recruitment
    - HCPs training meetings organisation and animation
    - Contact point for the internal and external clinical studies members
    - On-site monitoring visits (opening, follow-up and closure visits): Oversee progress of trials (record and report in accordance with protocol, SOPs, GCP)
    - Knowledge of ICH/GCP
    • Development of European medical education program for HCPs
    - KOL’s selection and collaboration
    - Interactive programs development and follow-up

Formations

  • Kungliga Tekniska Högskolan (Institut Royal De Technologie) (Stockholm)

    Stockholm 2008 - 2008 industrial management / project management
  • Ecole Biologie Industrielle Cergy

    Cergy Pontoise 2003 - 2008 French Engineering degree in Life sciences

Réseau

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