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Angélique BETTON

Castres

En résumé

Mes compétences :
CRO
Oncology
ICH-GCP
CTMS
Coordination
Pharmaceutical industry
International
SOP
SAE
Clinical Trials

Entreprises

  • Pierre Fabre - International Clinical Study Coordinator

    Castres 2004 - maintenant Phase III study in breast cancer for registration in China (since 2013)
    - Set up activity in China with 1 CRO
    - Responsible for SAEs (analysis, tracking, periodic review)
    - Responsible for SOPs implementation
    - Responsible for study deviation (periodic review, follow up of CAPA implementation)
    - Responsible for oversight of the CTMS
    - Involved in drafting study documents


    Phase III study in breast cancer for registration in Europe (since 2006)
    1000 patients all over the world,
    - Responsible for study activities conducted in 3 countries Pierre Fabre affiliates (France, Belgium, Portugal and 1 country handled by a CRO (India)
    - Presentation and organization of study meetings with investigators and CRA
    - Follow up of all the monitoring activities
    - Development of tools to track IPs
    - Involved in drafting SOPs (IP, SAE, monitoring, study deviations)
    - Validation of clinical data (446 patients)
    - Closing out activities

    Phase III study in lung cancer (since 2004)
    - Writing 170 SAE narratives
    - Closing out activities
  • Pierre Fabre - Clinical Research Associate

    Castres 2001 - 2004 - Therapeutic area: prostate cancer, lung cancer, mesothelioma...
    - Phase: I, II and III
  • Pierre Fabre - International Clinical Study Coordinator

    Castres 2001 - 2001 - Therapeutic area: lung cancer
    - Phase : II
  • AstraZeneca - Clinical Research Associate

    Rueil-Malmaison 2000 - 2001 - Therapeutic area: lung cancer
    - Phase: II and III
  • Pierre Fabre - Clinical Research Associate Trainee

    Castres 2000 - 2000 - Therapeutic area: prostate cancer, lung cancer and myeloma
    - Phase: II and III

Formations

Pas de formation renseignée

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