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Summary

With my practical experience in GCP and interest in clinical development in general I preferably like to work on a variety of tasks from starting up to closing, feasibility checks, selection visits, co visits and monitoring. My main interest is stimulating the trial team to follow the minimal GCP requirements as efficiently as possible and promote long standing relation ships with the trial site, including the corresponding increase in medical knowledge about the disease involved in the trial. If you ask colleagues about my personal properties they might say in general that I am enthusiastic, but calm and persistent if it comes to important GCP quality related matters, without losing the view on practicability. E.g. as a Quality System Manager I have introduced (internal) compliance checks to be performed together as a Team effort to enable a Clinical Platform to learn from trends. Also an important process for Specialised Nutrition was tackled, prepared and introduced: Release of study products, compliant with a well organised GCP- GMP interface which is a real challenge! In the past years I have developed a basic attitude regarding quality and motivating of colleagues to work compliant with SOPs and regulations and pay attention to the minimal GCP requirements.

Experiences

Current Experience

  • Lead Auditor
    Since August 2014
    Contribution at compliance factor and implementation QMS, with focus at auditing, supplier management, quality agreements and vendor qualifications.

Past Experience

  • Consultant/senior CRA the Netherlands
    November 2013 --- May 2014

  • Quality System Manager
    February 2010 --- June 2013
    Danone Research; coach for SOP owners, external independant Audits, Compliance Checks at Clinical Operations Platform

  • CSM
    January 2009 --- January 2010

  • CRA/Auditor
    January 2000 --- May 2009

  • Field Trial monitor
    January 1998 --- January 2000

  • Product Manager clinical chemistry
    September 1994 --- December 1998

  • Stafmedewerker
    September 1992 --- August 1993

  • Market Relation Manager
    January 1989 --- August 1992

Knowledge

LinkedIn Assessment :
GCPClinical trialsAudits/ComplianceGMPQuality SystemsLifesciencesPharmaceutical IndustrySOPAuditingCROClinical researchICH-GCPBiotechnologyLife SciencesCTMSSOPMedical DevicesRR&DscienceRegulatory affairs

Education

  • post academic Grade A in Epidemiology from Vrije Universiteit Amsterdam in 1993
  • HMI in Hoger management voor Bedrijven en Instituten from Instituut voor Bedrijfs Wetenschappen (IBW) in 1992
  • Drs in Chemistry (Masters for neurofarmacology and biophysical chemistry) from Radboud Universiteit Nijmegen in 1985
  • Gymnasium-B in from Thomas a Kempis college in 1977

Training and Certification

  • Epidemiologist Certification

Area / Region

Netherlands

Others

Driving License
  • No