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Summary

   

Experiences

Past Experience

  • Domain Expert Beerse, Belgium
    September 2016 --- December 2016

    Migration project (transfer of all trials to a new production environment):

    • Preparation of trial migration
    • Converting, creating and testing SAS-scripts for quality control of SDTM conform datasets (SAS Drug Development & SAS v9.2)
    • Quality control of executed migrations (in HP ALM)

  • Consultant Roeselare, Belgium
    February 2016 --- May 2016

    • Managing the preparation and writing of subsidy applications for innovative industrial R&D projects, for SMEs & larger companies
    • Assisting in the management of funded innovation and R&D projects
    • Interplaying with companies, research organisations and governmental departments

  • Development Manager Sint-Lambrechts-Woluwe, Belgium
    January 2015 --- February 2016

    Development, maintenance and testing of tools related to Data Management (DM) activities:

    • Definition of new requirements
    • Writing of documentation needed for implementation and validation of requirements
    • Testing and validation of implemented requirements
    • Reporting of bugs and resolution in cooperation with the IT department

  • Clinical data manager Sint-Lambrechts-Woluwe, Belgium
    November 2009 --- December 2014

    • Clinical trial protocol: development of the DM sections & final review
    • Case Report Forms (CRFs): definition & creation in the clinical database
    • Data validation plans (DVPs): development & maintenance
    • Crosschecks & validation checks programs: development & maintenance (QC)
    • Data handling, cleaning (QC) & reporting
    • Communication: with participating investigators & third parties (pharmaceutical companies, CROs & vendors) to ensure efficient data collection

  • Manager Leuven, Belgium
    January 2010 --- August 2010

    • Developing well structured application subsidy dossiers for innovative industrial R&D projects
    • Ensuring linguistic quality of application dossiers: spelling, grammar & style (Dutch)

  • Junior Consultant Kuurne, Belgium
    March 2009 --- October 2009

    • Managing the preparation and writing of subsidy applications for innovative industrial R&D projects, for SMEs & larger companies
    • Assisting in the management of funded innovation and R&D projects
    • Interplaying with companies, research organisations and governmental departments

  • Funding Engineer Ieper, Belgium
    September 2008 --- February 2009

    • Managing the preparation and writing of subsidy applications for innovative industrial R&D projects, for SMEs & larger companies
    • Assisting in the management of funded innovation and R&D projects
    • Interplaying with companies, research organisations and governmental departments

Personality

Self Assessment :
TrustFlexibilityAttention to detailInterest in knowledgeProblem solvingAnalytical thinking

Knowledge

Self Assessment :
Microsoft ExcelExcel VBASASSQLPython
LinkedIn Assessment :
Clinical Data ManagementData ManagementClinical trialsEnglishClinical researchCTMSGCPMicrosoft OfficeCRF designMicrosoft ExcelClinical DevelopmentPowerPointWindowsFrenchMicrosoft WordICH-GCPdutchSAS programmingSQLHTMLXMLVBA Excel

Skills and Expertise

Self Assessment :
Ensure data consistencyData validationData verificationEnsure data integrity

Education

  • Master in Bio-engineer in cell & gene biotechnology from KU Leuven in 2008

Training and Certification

  • Programming in VBA Excel 2010 in 2014 Training
  • Introduction to Monitoring Clinical Trials in accordance with ICH-GCP Guidelines in 2009 Training
  • Languages

    BrightOwl Assessment:
    Self Assessment:
    Dutch
    Native
    English
    Professional Proficiency
    French
    Elementary Proficiency
    German
    Elementary Proficiency

Work Preferences

  • Notice Period:
    1 week
  • Positions I am interested in:
    Data Manager
  • Locations I am interested in:
    Ghent, Belgium
  • Work From Home:
    Yes, 2 to 5 days per week
  • Work Regime:
    Permanent position :    100% FTE
    BrightOwl employee :    100% FTE
  • International:
    No

Publications

    Expert has 1 publications (Will be avalible with full profile)

Area / Region

Gent, België

Others

Driving License
  • Yes