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Nathalie VANDENHOUDT

BRUXELLES

En résumé

Mes compétences :
Recherche clinique Affaires Réglementaires Da
Recherche scientifique

Entreprises

  • GSK - Clinical Regulatory Affairs Manager

    2016 - maintenant

  • CVO-EUROPE - Vaccine Supply Coordinator (for GSK)

    LYON 2013 - 2016

  • Bone Therapeutics S.A. - Clinical Study Manager & Regulatory Assistant

    Gosselies 2011 - 2012 Project Management including:

    - Management and Coordination of Clinical Research and Development programs: phase I, II and III international trials
    - Review and Analysis of Clinical Data and Results
    - Scientific Writing: preparation of study documents (Clinical Study Reports, Protocols, Informed Consent Forms, Case Report Forms, Study Manuals...) according to ICH-GCP
    - Working in close collaboration with other Departments (QA, QC, Production, R&D,...).
    - Site contacts (selection, contract negociation, initiation, follow up, contact with Ethics Comittees,...)
    - Contact with services providers and coordinating them
    - Reporting and notification of Safety Events

    Regulatory tasks:

    - Communication and meeting preparation with Competent Authorities in Belgium and other European countries (preparation of submission packages, scientific advices,...)

  • Crossover CRI SA - Clinical Study Coordinator / Clinical Research Associate

    2009 - 2011 - Management of the administrative part of Clinical Research on site (from first contacts with sponsors until the close out visit)
    - Coordination trials between different departments (medical department, radiology, nuclear medicine, laboratory,...) involving lots of people.
    - Management of Clinical Studies in different departments: oncology, dermatology, ophthalmology, rheumatology, anesthesiology, gynecology, cardiology,…
    - Reviewing of academic clinical protocols according to ICH-GCP guidelines
    - Submission of academic trials to the Competent Authorities

    - Site activities (initiation - monitoring - close out visits) in Belgium both in Dutch and French.

Formations

  • Université Libre De Bruxelles ULB (Bruxelles)

    Bruxelles 2001 - 2009 Biologie moléculaire et médicale, PhD virologie
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