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Camille WOUTERS

Paris

En résumé

Pas de description

Entreprises

  • Actelion - Data Scientist

    Paris 2015 - maintenant
  • Aptiv Solutions - Clinical Data Manager

    2012 - 2015 In charge of an Endpoint Cardiology Study (Clintrial):
    o Create and maintain the Data Management Plan (DMP), Data Handling Manual and other study specific procedures documentation
    o Coordinate and conduct the data cleaning process:
    - Discrepancy review
    - Generate and distribute queries and follow-up until resolution
    o Coordinate import/ exports of data with external data providers
    o Coordinate interim data analysis of the database according to the project timelines and database QC plan
    o Maintain study folder (TMF)
    Involvement in different studies:
    o Data QC
    o Testing of the validation check Specifications
  • Merck Serono à Genève (Suisse) - Stage en data management

    2011 - 2011 Involvement in the Set-up/Conduct of an EDC oncology studies (InForm):
    - MedDRA and WhoDrug coding (Concomitant medication, Adverse Event, Medical History and Drug History): manual review of automatic coding
    - Raising of coding queries
    - Consistency review of coding data listing
    - Coding set-up and testing
    - SAEs reconciliation in partnership with Drug Safety Department
    - Poster Writing on coding data retrieval and analysis
    - CRF/DVP testing and validation: data entry and writing of Test Value and Finding Forms writing
    Writing of Pharmacy Thesis
  • Laboratoires SERVIER - Stage en data management

    2010 - 2010 Involvement in the Conduct of a Cardiology EDC study (Clintrial/InForm):
    - Cleaning of queries: discrepancy listing edition, discrepancy review and discrepancy update
    - Loading of external randomisation data
    - Quality Control of Life Questionnaire

Formations

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