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Summary

I have always an outspoken interest in clinical research and am an experienced Clinical Data Manager in oncology, with more than seven years work experience at the Radiotherapy Department of the UZ Brussel.  I have responsibility from the set up to the closing of phase I, II and III clinical trials, for the collection and processing of all the relevant information required for the clinical research and assisting the Clinical Research Physician in statistics analysis and interpretation for Medical publication. And now I am actively looking for a new challenge.

Experiences

Current Experience

  • Clinical Data Manager (DM)
    Since December 2007
    Responsible for the collection and processing of all the relevant information required for the set up of a clinical trial, cleaning of the data, reporting to the Study Coordinator/Clinical Research Physician. - Create database and Case Report Forms (CRFs) including the guidelines for the CRFs completion in accordance with the study protocol. - Conduct data collection and quality control to assure that the data are reliable and processed in compliance with ICH-GCP requirements. - Conduct thorough cross check programs for consistency and validation checks on the data. - Ensure good communication with participating investigators and other study sites (at European level) in order to resolve queries and missing data. - Conduct the reconciliation of SAEs. - Organize the preparation and execute the review with the Study Coordinator/Clinical Research Physician on a regular basis. - Submit the necessary study documents for approval of the Ethics Committee and the Competent Authorities. - Conduct the registration of the study at clinicaltrial.gov - Ensure proper filing of all study related documents, in compliance with ICH-GCP requirements. - Conduct and assist the Study Coordinator/Clinical Research Physician in data/statistics analysis and interpretation for Medical writing and publications.

Knowledge

Self Assessment :
Clinical Data Management (CDM)Clinical researchClinical Study DesignClinical trial designClinical trial managementClinical trialsGood Clinical Practice (GCP) Scientific writing Phase ICancerClinical monitoringData cleaningData AnalysisData entryData ManagementDatabase design and maintenanceElectronic Data Capture (EDC) EnglishEthics submission and approval processGCPICH GCP guidelinesICH-GCPInformed Consent ProcessInterpret clinical trial resultsMedical oncology Medical writingMicrosoft OfficeMicrosoft ExceloncologyoncoPatient Follow UpPatient Reported Outcome Measures (PROMs)Pharmaceutical IndustryPhase IPhase IIPhase IIIPhase IVPhases of clinical development (phase I to IV)Principles and ethics of clinical researchQuality of Life (QoL) outcomesRadiation oncologyRandomization and blindingRegulatory affairsRegulatory RequirementsRegulatory submissionsSafety concerns (such as therapeutic ratio with respect to possible adverse effects)Safety trialsScientific WritingSearch literature on clinical trialsStatistical considerations in design and analysisStudy outcomes and outcome measuresInformed Consent DocumentsWriting Study Procedures and SOPs
LinkedIn Assessment :
Clinical trialsClinical Data ManagementPilatesData ManagementClinical researchEDCCRF design

Education

  • Master's degree in Medicine from Université libre de Bruxelles in 2007
  • Postgraduate in Food Science and Technology from Universiteit Gent in 2004
  • Doctor of Medicine (M.D.) in Medicine from Universitas Katolik Indonesia Atma Jaya in 1995

Training and Certification

  • GCP-IST in 2015 Training
  • Quality of Life Conference, Symptom Research and Patient Reported Outcomes in Cancer Clinical Trials in 2012 Training
  • Organisation and Implementation of Cancer Clinical Trials in 2011 Training
  • Quality of Life, Symptom Research and Patient Reported Outcomes in Cancer Clinical Trials in 2011 Training
  • European Forum for Good Clinical Practice (EFGCP) in 2010 Training
  • Methodology of cancer clinical trials: the next generation in 2010 Training
  • GCP-IST-Safety reporting in 2009 Training
  • Clinical trial statistics for non statisticians in 2008 Training

Work Preferences

  • Notice Period:
    4 weeks
  • Work From Home:
    Yes, 0 to 2 days per week
  • Work Regime:
    Permanent position :    FTE 50%-100% FTE
  • International:
    Yes

Publications

    Expert has 3 publications (Will be avalible with full profile)

Area / Region

Gent, België

Others

Driving License
  • Yes