BrightOwl Loader Loading

Experiences

Current Experience

  • Clinical Team Manager
    Since March 2015
    • 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, eCapture, Mednet, 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
    February 2013 --- March 2015
    • eCRF data input (Medidata RAVE, 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 • Contact liaison for the Ethics Committees

  • DCO (Data Coordinator Officer)
    March 2012 --- February 2013
    Data Monitoring & Source Data Verification. Site support for Merck.

  • Klantenbegeleiding
    October 2011 --- May 2012
    Guide People, compose training programs, ...

Personality

Self Assessment :
Analytical thinkingProblem solvingOrganization

Knowledge

Self Assessment :
R&DSerious Adverse Event (SAE)Report WritingPresentationsPowerPointPhase IVPhase IPhases of clinical development (phase I to IV)PharmacovigilancePatient Follow UpOracle ClinicalMicrosoft WordMicrosoft ExcelAdverse Events (AE)Clinical Data Management (CDM)Clinical monitoringClinical study reportsClinical trial audits and inspectionsCRFCRF designCRODatabase design and maintenanceMedical Devices
LinkedIn Assessment :
Pharmaceutical IndustryGMPClinical trialsSOPVaccinesoncologyValidationClinical DevelopmentCTMSGCPFDACRO

Skills and Expertise

Self Assessment :
Build and manage the Trial Master File (TMF) Interact with physicians Monitor a clinical study Write protocols Write papersAdverse event reportingResolves queriesClinical data collectionCapture data on source documentsReview data interpretationSerious Adverse Event (SAE) Reconciliation

Education

  • Master in Physical Education and Fysiotherapy from Vrije Universiteit Brussel in 2011

Training and Certification

  • Introduction GCP-ICH guidelines in 2011 Training
  • Languages

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

Work Preferences

  • Positions I am interested in:
    Clinical Research Associate (CRA)
  • Locations I am interested in:
    Belgium
  • Work From Home:
    Yes, 0 to 3 days per week
  • Work Regime:
    Permanent position :    100% FTE
  • International:
    Yes

Area / Region

Ghent, Belgium

Others

Driving License
  • Yes