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Summary

profound knowledge of the Clinical Development process in general,  profound  experience in Clinical operations and Data Management activities for over 15 years.

-    compiling and submission of Clinical Trial Applications to ca and ec as well as site Qualification, initiation, follow up, close out - Training and support of junior CRA’s.
-     coordination and Planning to adhere to time lines for submissions, Interim Analysis, and data base closure in close         collaboration with other departments.

supervision and follow up of activities outsourced to external parties.

creation of Presentations and workshops regarding Data Management/review, handling science)" >Protocol violations and safety reporting.

experienced in working with/at CRO’s as well as Pharmaceutical/Biotechnology companies on international trials.



Personality

BrightOwl Assessment :
Anger commandDependabilityOrganizationDiligenceStrivingAuthenticityCreative thinkingInterest in knowledgeCuriosityPerspectiveImpulse commandEfficiency

Knowledge

BrightOwl Assessment :
Cardiovascular diseasesGastroenterologyEndocrinology and metabolismNeurologyInfectious diseasesMedical oncology Search literature on clinical trialsUnderstanding of regulatory guidelinesPhase IPhase IIPhase IIIScientific methodologyInterpret clinical trial resultsProject ManagementClinical trial design

Skills and Expertise

BrightOwl Assessment :
Coach and provide guidance to clinical staff.Teach university studentsassess the needs of the project(s)/program(s) and make changes in process, work flow and/or assignments.Direct co-workers to achieve resultWork collaboratively with the other members of the clinical research team Design the studyWork with coordination and data management teamsDevelop a clinical strategy to bring a next drug or indication forwardDevelop regulatory strategy

Education

  • Managing multidisciplinary projects in from Cevora in 2013
  • Project Management in from Cevora in 2013
  • Post-graduate degree - Business Management in from K.U.Leuven in 1995
  • Master of Science in Biomedical Sciences, Major in Research in from K.U. Leuven in 1990

Languages

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

Work Preferences

  • Work From Home:
    No
  • Work Regime:
    Permanent position
    BrightOwl freelancer :    20 Hours per week
    BrightOwl employee
  • International:
    Yes

Publications

    Expert has 2 publications (Will be avalible with full profile)

Area / Region

Putte

Others

Driving License
  • Yes

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