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Experiences

Current Experience

  • International Clinical Project Manager (CPM)

    Brussels, Belgium
    Since February 2008

Past Experience

  • Trial Coordinator

    January 1991 --- January 2008

  • Clinical Project Manager (CPM)

    January 1991 --- January 2007

Personality

Self Assessment :
Result OrientedInterest in knowledgeIndependenceEfficiencyAttention to detailCollaborationProblem solvingProactivityCreative thinkingCoordination

Knowledge

Self Assessment :
21 CFR Part 11Biological Drug DevelopmentBudget ManagementCell SignalingClinical DevelopmentClinical operationsClinical study reportsClinical trial managementClinical Trial Management System (CTMS)CRF designDeveloping Clinical Trial ProtocolsDiabetesEfficacy trialsEnglishEthics submission and approval processFDAGood Clinical Practice (GCP)Informed Consent DocumentsInternational Project ManagementIVRSMicrosoft OfficeoncologyOutlookPediatricsPharmaceutical IndustryPhases of clinical development (phase I to IV)Safety trials

Skills and Expertise

Self Assessment :
Develop clinical trial protocols Interact with physicians Write protocolsAttend at steering committee meetingsAttend investigator meetingCollaborate with medical teamCollaborate with principal investigatorCollaborate with project teamConduct studiesCreate study documentsInteract with KOLInteract with CROsManage budgetsManage Clinical Trial Management System (CTMS) Manage multiple projectsManuscript reviewObserve trends in dataPlanning clinical studiesProvide trainingRead medical literatureReview clinical study reportsReview dataSerious Adverse Event (SAE) ReconciliationSet up a clinical studyWork collaboratively with the other members of the clinical research team Work with coordination and data management teams

Education

  • Master in Physical Education and Fysiotherapy from Free university Brussels in 1982

Languages

BrightOwl Assessment:
Self Assessment:
French
Native
Dutch
Professional Proficiency
English
Full Proficiency

Area / Region

Brussels, Belgium

Others

Driving License
  • Yes

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