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Experiences

Current Experience

  • Global Monitoring Organization Country Head UK & Benelux
    Since March 2015
    Responsible for: - The conduct of all clinical trials in the applicable territory within GCP Guidelines, local regulations and company SOPs. Therapeutic areas: RSV, Flu, Staph Aureus, Pertussis, Meningococcal (B), GBS including Maternal Immunization. - Coordinate with the R-Physician the feasibility activities to be conveyed to the GMO Regional Head as required. - Interacting with Regional Physicians, as well as with study investigators for the trial planning and execution including safety aspects of the trials conducted in the assigned territory. - Ensure that clinical and regulatory activities related to the planning and executions of clinical trials in the assigned territory are in line with the company strategic plans and performed according to the highest quality standards. - Resource allocation, people management, training and development and budget control within the assigned territory for Regional Physicians, Clinical Trial Managers, CRA’s and CTA’s. In addition: • Core member of the GSK Amsterdam affiliate Management Team. • Core member of the Global Study Document Review Committee (SDRC). This Committee reviews and approves all relevant study documents including but not limited to ICF’s, Diary Card’s, phone call scripts, Data Management related documents and others for all (legacy) Novartis vaccines studies on a regular basis, including chairman (a.i.) for this committee for over one year. • Coordinator of the local (Amsterdam) GSK Emergency Management Team. • (co) author of the Novartis Vaccines global ICF template and SOP as also being owner or author from other global SOP’s and or WI’s • Global representative for legacy Novartis Global Monitoring Organization on the CTA transition (Novartis --​> GSK) work stream, followed by Implementation team.

  • Core Member of the global Study Documents Review Committee (SDRC)
    Since March 2015

Past Experience

  • GMO Country Head UK/Benelux
    October 2013 --- March 2015

  • Core Member of the global Study Documents Review Committee (SDRC)
    February 2013 --- March 2015

  • Clinical Operations Manager, Global Monitoring Organization, Region Central & Northern Europe
    February 2011 --- October 2013

  • Member of the projectgroup Clin Ops
    January 2009 --- September 2013

  • Head of Operations / Ass. Dir. RSM
    June 2010 --- February 2011

  • Ass. Dir. RSM /Head of Operations
    October 2008 --- June 2010
    Head of operations for the Benelux CR&D department for the following therapeutic domains: - CNS (Alzheimer), Cardiology, Bone, Inflammation, Vaccins and phase 1 studies. Also line manager for Project managers and CRA's (both Netherlands and Belgium)

  • Senior Site Manager
    March 2008 --- October 2008

  • (International) CRA
    June 2001 --- February 2008
    Monitoring different studies in different therapeutic areas such as; Diabetes, nefrology, cardiovascular including 2 (international) IMT studies. During these studie I have also become specialized in IMT imaging.

  • Lab manager
    January 1996 --- June 2001
    I started this lab in 1996 and have performed all tasks, including interviews with customers, preparing tenders. I was responsible for management including line management, distribution of work, QA, contacting/arrangements contractors etc.

  • Chief Technician Laboratory Clinical Chemistry
    January 1988 --- January 1996

  • Laboratory Technician
    February 1981 --- July 1988

Personality

Self Assessment :
CollaborationCommunicativeAdaptabilityAnalytical thinkingApproachabilityAssertivenessAttention to detailCompetitivenessCritical thinkingEfficiencyProblem solvingResiliencySelf-disciplineResponsibilityStriving

Knowledge

Self Assessment :
Labtechnician R&D Phase IClinical DevelopmentClinical monitoringClinical operationsClinical trial managementGood Clinical Practice (GCP)ICH guidelinesInfectious diseasesInformed Consent DocumentsInformed Consent ProcessInternational Project ManagementLaboratoryLaboratory ManagementLeadershipmanagementOperations Managementpeople managementPharmaceutical ResearchPhase IPhase IIPhase IIIPhases of clinical development (phase I to IV)PresentationsProblem SolvingTeam LeadershipTeam BuildingVaccines
LinkedIn Assessment :
Clinical DevelopmentTherapeutic AreasDiabetesCardiologyGCPPharmaceutical IndustryClinical researchClinical trialsVaccinesClinical monitoringICH-GCPCROEDCCTMSClinical operationsGood Clinical Practice (GCP)Standard Operating Procedure (SOP)

Education

  • Equal to Bachelor in HLO Clinical Chemistry and Haematology from ROC Utrecht in 1992
  • Associate’s Degree in Laboratory Clinical Chemistry from Anthoni van Leeuwenhoek Instituut in 1982
  • Equal to Bachelor in HBO-A Clinical Chemistry from Van Leeuwenhoek Inst. – Delft in 1982
  • in from Hugo de Groot in 0
  • in from Primary school in 0

Training and Certification

  • Development Leadership in 2014 Certification
  • Multiple other trainings. See LinkedIn in 2014 Certification
  • Multiple GCP trainings in 2012 Certification
  • Integral Quality Care in 1998 Certification
  • Management Training in Health care in 1990 Certification

Languages

BrightOwl Assessment:
Self Assessment:
Dutch
Native
English
Full Proficiency
German
Professional Proficiency

Area / Region

Utrecht, Netherlands

Others

Driving License
  • Yes