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Experiences

Past Experience

  • Clinical Quality Associate Diegem, Machelen, Belgium

    January 2015 --- December 2015

    lead and mentoring global departmental Training coordinators

    lead lean Six Sigma project (green belt) on improvement of development/revision of controlled documents in Clinical Development

    perform Compliance and gap assessments

    provide Training on Clinical Development processes to global department

    lead global procedure management: content review of all procedures Clinical Development is in scope, coordination or development/revisions process by liaising with global partners

    process improvements/capa

  • Clinical Quality Associate Boom

    January 2012 --- December 2014

    review site approval documents for global trials per iso14155:2011

    provide gcp advice to study teams provide Training (gcp, procedures etc)

    improvement of global processes global deviation management (site and sponsor related issues)

    perform Compliance assessments

    assist in set up of regional mock inspections

    create and maintain global trainings

  • Prevention Advisor

    September 2009 --- May 2012

    ensure all local regulatory requirements around wellbeing and safety and abbott standards on ehs (environment, Health and safety) are met for the abbott Vascular diegem site

    provide Training on ehs requirements to new employees and contractors

    maintain ehs procedures, Training matrix and Training material

  • Quality Compliance Coordinator

    July 2009 --- December 2011

    maintain compliant Training process for all employees in clincial department

    lead review of global Clinical research Training procedure

    perform Compliance assessments on Training related topics

    work on improvement of global processes within Training department

    establish function specific Training plan templates for global Clinical research department

    work on globalization of functional Training plans implement and improve electronic Training plan creation and approval (globally)

    organize trainings for emea/ap department to improve business knowledge and processes

    development of elearning for global clinical department mentor global Clinical research Training coordinators

    coordinating continuous improvement detection for emea / asiapac

  • Clinical Systems Analyst

    July 2009 --- December 2010

    provide Training to all new employees on siebel, documentum, cognos and kofax

    create business cases for system enhancements

    create and maintain Training material and user guides

  • Clinical Trial Assistant (CTA)

    March 2006 --- June 2009

    mentor of new cta's

    quality check of essential documents in trial master file

    train all new Clinical employees on siebel and webtop documentum sete up international (emea, apac) study

    prepare Ethics committee submission packages

    provide Training material to employees for Clinical systems

    work with a global team to improve Clinical systems

    budget management ous trial

  • Physiotherapist

    August 2005 --- December 2005
    treat patients with wide range of injuries (post operative, sport injuries,..) at any extremity with an exercise focused therapy

Personality

Self Assessment :
AdaptabilityEfficiencyIndependenceFlexibilityAttention to detailInnovative thinkingCritical thinkingCollaborationAnalytical thinkingProblem solving

Knowledge

Self Assessment :
Process improvementClinical researchClinical operationsGood Clinical Practice (GCP) Medical devicesCAPAClinical trialsQuality Assurance (QA)Writing Study Procedures and SOPsUnderstanding of regulatory guidelines
LinkedIn Assessment :
Clinical researchCTMSClinical trialsMedical DevicesGCPCardiologyFDA

Education

  • in Prevention Advisor III from CRESCEPT in 2009
  • Master in Sportphysiotherapy from Vrije Universiteit Brussel in 2006
  • Master in Rehabilitation Sciences & Physiotherapy from Vrije Universiteit Brussel in 2005
  • in from KA Boom in 2000

Training and Certification

  • Lean Six Sigma Green Belt in 2015 Certification
  • Lean Six Sigma Yellow Belt in 2015 Certification
  • CAPA Evaluation / Investigation / Resolution Plan in 2012 Certification

Languages

BrightOwl Assessment:
Self Assessment:
Dutch
Native
English
Professional Proficiency

Area / Region

Boom

Others

Driving License
  • Yes

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