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Summary

Clinical Research Professional with:
* >10 years experience in clinical research (of which >6 years operational management in clinical r&d)
* several ta/indications experience
* strong experience in clinical Project Management (e.g. global trial management)
* strong sponsor experience, as well strong experience working directly for sponsors
* passionate about clinical r&d

acrp certified CRA (sep 2012)

Experiences

Current Experience

  • Head Clinical Affairs

    Kontich, Belgium
    Since April 2016

    overall management and direction of Clinical research&development and data collection (flen pharma's Clinical trials, iis, observational studies, patient case series/studies) to ensure achievement of company’s clinical affairs targets (development and approval of new products and existing products maintain marketability).

    Overall management and direction of clinical research&development and data collection (Flen Pharma's clinical trials, IIS, observational studies, patient case series/studies) to ensure achievement of company’s clinical affairs targets (development and approval of new products and existing products maintain marketability).

Past Experience

  • Head Clinical Operations Kontich, Belgium

    November 2015 --- March 2016
    overall management and direction of the Clinical research programs to ensure achievement of the company’s Clinical operations targets (development and approval of new products and that existing products maintain marketability).

  • Clinical Project Manager (CPM)

    March 2015 --- October 2015
    management, coordination and oversight of flen pharma's Clinical trials.

  • Clinical Project Manager (CPM)

    June 2011 --- January 2015
    Clinical Project Management Medical Device studies (ich-gcp/iso14155) line & people management; supervision and Coaching of cras

  • Team Leader Clinical Research Coordinators

    February 2010 --- May 2011
    management and daily coordination of Clinical research coordinators team (general people management, allocation of projects, supervision and Coaching)

  • Clinical Research Coordinator

    October 2007 --- January 2010
    coordination & monitoring of Clinical (pre-)studies according to ich-gcp, pm: Planning & tracking timelines of r&d projects, organisation of project team meetings

  • Clinical Research Coordinator

    October 2000 --- September 2007
    pm/coordination of Clinical research collaborations (Phase II/iii trials) according to ich-gcp

  • Research assistant Immunology

    August 1999 --- July 2000
    pre-Clinical research: multiple sclerosis, osteoarthritis

Personality

Self Assessment :
Attention to detailAdaptabilityApproachabilityCommunicativeCoordinationFlexibilityIndependenceInterest in knowledgeKindnessOptimismProactivityProblem solvingResponsibilityResult OrientedSociability

Knowledge

Self Assessment :
Cardiovascular diseases
LinkedIn Assessment :
ICH-GCPClinical trialsCROClinical DevelopmentClinical researchMedical DevicesDrug DevelopmentImmunologyClinical monitoringProtocolCCRAClinical operationsoncologyCTMSSOP developmentTrial ManagementEDCRegulatory submissionsClinical Data ManagementBiopharmaceuticalsRegulatory affairsLifesciencesLife SciencesISO14155Clinical Project ManagementItalian languagesVirologyNon-clinicalBudget MonitoringProject PlanningSite ManagementPhase ISite InspectionsFAHMP inspectionMedical Device DirectiveDermatologyWound Care

Education

  • certified post-academic education in Clinical Research option drug research from Universiteit Antwerpen in 2008
  • BSc in Medical Lab technology from AP Hogeschool Antwerpen in 1999
  • in from St.-Lodewijkscollege Lokeren in 1996

Training and Certification

  • CCRA in 0000 Certification

Languages

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

Work Preferences

  • Notice Period:
    5 weeks
  • Positions I am interested in:
    Clinical Operations Manager Clinical Project Leader Clinical Project Manager (CPM) Clinical Research Manager Clinical Trial Manager (CTM) Clinical Trial Specialist (CTS) Global Clinical Project Manager (GCPM, GTM) Senior Clinical Project Manager (CPM) Associate Director Clinical Operations
  • Locations I am interested in:
    Belgium
  • Work From Home:
    Yes, 1 to 3 days per week
  • International:
    Yes

Area / Region

Belgium

Others

Driving License
  • Yes

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