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Experiences

Current Experience

  • Global Lead CRA

    Home based
    Since August 2007
    Coaching

    Communication CRA team (internal & CRO), participate in selection vendors, training/coaching junior CRA's, development of training tools + presentations (international investigator meeting/Regular team meetings (webinar)), audit FU (CAPA), representative of monitoring team in project team.

    Development of study documents: Protocol review, review of CRF, ICF, CRF guidelines

    Development of recruitment planning & monitoring guidelines

    Global trials

     

Past Experience

  • Clinical Project Manager (CPM) Home based

    June 2011 --- April 2014
    Project Planning

  • Clinical Project Manager (CPM) Oostakker, Gent, België

    February 2007 --- June 2012
    Phase III

  • Clinical Project Manager (CPM) Brussels, Belgium

    December 2009 --- October 2010
    Phase IV

  • Clinical Project Manager (CPM) Niel

    June 2008 --- May 2009
    Business Development

Personality

Self Assessment :
Problem solvingAttention to detailCreative thinkingCollaboration

Knowledge

Self Assessment :
oncologyOphthalmologyPhase IIPhase IIIPhase IVPulmonary diseasesSupervising CRAsUrologyCardiovascular diseasesClinical researchClinical trial budgetingClinical trial managementContract negotiationCross-functional team leadershipCTMSDesigning case report formsDrug regulatory authoritiesEfficacy trialsElectronic Data Capture (EDC) Ethics submission and approval processFDAICH-GCPInformed Consent ProcessNeurological surgery

Skills and Expertise

Self Assessment :
Design case record forms Monitor a clinical studyAssess site feasibilityCalculate trial timelinesCoach clinical staffCollaborate with project teamCommunicate with investigatorcoordinating research projectsCreate clinical documentsDesign subject consent formEthics committee submissionsInteract with CROsInteract with ethics committeeManage projects resourcesSupervise clinical monitorsSelect investigatorsReview vendor reportsReview study protocolsReview monitoring reportsRespond to audit findingsRegulatory submissionsProvide trainingPresent data at congressOrganise meetingsManage vendor budgetsManage study budget

Work Preferences

  • Work From Home:
    Yes, 4 Days
  • Work Regime:
    BrightOwl freelancer :    max 16h/w Hours per week
  • International:
    Yes

Area / Region

Gentbrugge, Gent, België

Others

Driving License
  • Yes

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