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 trialseCRF 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 trialsmanagement 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 • 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

Similar Candidates

Other Candidates in Belgium

Other Candidates in Ghent

Other similar Candidates in Ghent

Other Candidates

Most Recent Searches

Most Famous Searches

You might also like