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Experiences

Current Experience

  • Clinical Team Manager Dendermonde, België
    Since July 2012

    • Daily follow-up and leading of the research team (3 Clinical Research Coordinators and 1 Administrative Assistant)

    • Reporting to the management

    • Implementation of ISO 14155:2011 standard throughout the FMRP activities

    • Development of Clinical Investigation Plans

    • Development and management of eCRF (EDC2GO) for clinical trials

    • eCRF data input (Medidata RAVE, KIKA, eCapture, Mednet, webCRF, iMedidata, MERGE Veracity, Oracle, ...)

    • Contact liaison for Belgian and German Competent Authorities

    • Contact liaison for the Ethics Committees

    • Coordination and support of investigational sites in Belgium, Germany, Italy, Australia and Brazil

    • Monitoring of investigational sites in Belgium

    • Data analysis (SPSS)

    • Report writing of clinical trials

    • Management of budget proposals for upcoming research projects

    • Creation of presentations for international congresses (CACVS, LINC, Charing Cross, EuroPCR, MEET, CIRSE, VIVA, VEITH, ...)

    • Ghostwriting in peer-reviewed journals (JVS, JCVS, JEVT, ...)

    • Organization of workshops

Past Experience

  • Clinical Research Coordinator Dendermonde, België
    January 2011 --- June 2012

    • eCRF data input (Medidata RAVE, KIKA, eCapture, Mednet, webCRF, iMedidata, MERGE Veracity, Oracle, ...)

    • Submission to the Ethics Committee

    • Monitoring of investigational sites in Belgium

    • Data analysis (SPSS)

    • Creation of presentations for international congresses (CACVS, LINC, Charing Cross, EuroPCR, MEET, CIRSE, VIVA, VEITH, ...)

    • Organization of workshops

Personality

Self Assessment :
Analytical thinkingAttention to detailCritical thinkingInterest in knowledgeOptimismProblem solving

Knowledge

Self Assessment :
Medical devicesCardiovascular diseasesClinical Data Management (CDM)Clinical monitoringClinical Study DesignElectronic Data Capture (EDC) EnglishICH-GCPInformed Consent ProcessPhase IVVascular surgery
LinkedIn Assessment :
Clinical researchClinical trialsClinical trial managementICH-GCPClinical monitoringMedical DevicesCTMSClinical Data ManagementGCPClinical DevelopmentCRORegulatory submissionsClinical Study DesignEDCFDAProtocol

Skills and Expertise

Self Assessment :
Act as the main line of communication between the sponsor and the investigator Design case record forms Develop clinical trial protocols Interact with nurses Interact with physicians Interpret data Report dataCoach staffComplete case report form (CRF)Conduct monitor visitsConduct site initiationCoordinate ethics committeeRegulatory submissionsSolve problems

Education

  • Master in Health Care Management and Policy from Universiteit Gent in 2010
  • Master in Logopaedic and Audiological Sciences from Universiteit Gent in 2008

Area / Region

Hamme, België

Others

Driving License
  • No