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Summary

After a master degree in Biology with a specialization on Clinical Trial’s Management, I am in charge of the implementation of SDTM standard into a CRO. I also involve in the training of a Data Management team. Regarding the technical aspect, I focus on the development of database mapping specifications to produce SDTM datasets from source data.

Previously, I worked as a Project Manager in data base conversion in SDTM standard. My main activities were the co-ordination of all project related activities (planning, resourcing and financial aspects of the project). I also had to deal with the management of the project team on a daily basis.

Experiences

Current Experience

  • CDISC Specialist Ottignies
    Since June 2014

    Mapping of client data using CDISC
    Transfer of data from metadata into CDISC
    Annotation of eCRFs and CRFs using CDISC Terminology
    Preparation of clinical data CDISC conversion definitions
    Quality Control of all project deliverables
    Responsibility for the timely delivery of a CDISC-compliant submission package

Past Experience

  • Project Manager Brussels
    November 2013 --- June 2014

    Co-ordination of projects related activities
    Management of project team on a daily basis
    Responsible for planning, implementing and reviewing a project (technical, timing, resourcing and financial aspects)

  • Data Integration Specialist Brussels
    November 2012 --- November 2013

    Mapping of client data using CDISC
    Transfer of data from metadata into CDISC
    Annotation of eCRFs and CRFs using CDISC Terminology
    Preparation of clinical data CDISC conversion definitions
    Quality Control of all project deliverables
    Responsibility for the timely delivery of a CDISC-compliant submission package

  • Consultant Clinical Data Manager via 4Clinics Ottignies
    August 2012 --- September 2012

    Development and review of data management procedures for clinical trials with sponsor companies and other departments
    Coordination of overall data management by serving as primary contact for the sponsor, external data providers, and all project team members.

  • Trainee Clinical Data Manager Waterloo
    April 2012 --- July 2012

    Development and review of data management procedures for clinical trials with sponsor companies and other departments
    Coordination of overall data management by serving as primary contact for the sponsor, external data providers, and all project team members.

  • Trainee Clinical Study Coordinator Montpellier
    October 2011 --- March 2012

    Tracking and reporting trial documents
    Updating clinical trial databases
    Prepare, collate, distribute and archive clinical documents and correspondence
    Updating manuals/documents (e.g., patient diaries, instructions) and documenting proper destruction of clinical supplies

  • Clinical Research Laboratory Technician Rennes
    February 2011 --- May 2011

    Participate to the data collection
    - Record and update adverse events, intervene as appropriate
    - Monitor and document study subject compliance
    - Maintain accuracy, accessibility, and confidentiality in volunteer/patient records
    - Record and communicate or resolve any discrepancy to study protocols in regards to laboratory

Knowledge

LinkedIn Assessment :
Clinical trialsCROPharmaceutical IndustryClinical Data Management (CDM)CDISCGCPICH-GCPClinical DevelopmentClinical Study DesignSDTM

Education

  • Master 2 Professionnel in Conception, gestion et évaluation des essais thérapeutiques from Faculté de médecine de Montpellier in 2012
  • Master I in Molecular Biology from Université de Rennes I in 2011

Area / Region

Brussels

Others

Driving License
  • Yes