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Summary

experience : over 18 years in the pharmaceutical business & more specifically in Clinical Trial supplies. over 12 years of Project Management experience in Clinical Trial supplies. over 11 years of people management experience. 2 years as qa manager

goals : give internal and external consultancy using my experience on ct supplies and qa matters. manage projects in the Pharmaceutical Industry.

specialties: Clinical Trial materials Supply Chain (from incoming bulk until the distribution of the finished product, the returns of these, the final reconciliation and finally the destruction), people management, Project Management, Quality Assurance

Experiences

Current Experience

  • Regional AD APAC & EMEA, Global Clinical Supplies


    Since October 2011
    management of the chinese depot (beijing) and emea central depots (in ireland, russia, south africa & ukraine), taking care of the storage and distribution of products for Clinical trials, part of the global gcs department, coordinating the Packaging and distributing products for Clinical trials all over the world. expertise in refrigerated shipments, close tracking of all shipments until arrival and general Project Management of global Packaging & distribution. Management of the Chinese depot (Beijing) and EMEA central depots (in Ireland, Russia, South Africa & Ukraine), taking care of the storage and distribution of products for clinical trials, part of the Global GCS department, coordinating the packaging and distributing products for clinical trials all over the world. Expertise in refrigerated shipments, close tracking of all shipments until arrival and general project management of global packaging & distribution.

Past Experience

  • Global Clinical Supplies Regional Manager APAC & EMEA

    January 2011 --- October 2011
    management of the apac central warehouses (china & singapore) and emea central warehouses (in ireland, russia, south africa & ukraine), taking care of the storage and distribution of products for Clinical trials, part of the global gcs department, coordinating the Packaging and distributing products for Clinical trials all over the world. expertise in refrigerated shipments, close tracking of all shipments until arrival and general Project Management of global Packaging & distribution.

  • Regional Manager, Global Clinical Supplies EMEA

    April 2010 --- January 2011
    management of the emea central warehouses (in ireland, russia, south africa & ukraine), taking care of the storage and distribution of products for Clinical trials, part of the global gcs department, coordinating the Packaging and distributing products for Clinical trials all over the world. expertise in refrigerated shipments, close tracking of all shipments until arrival and general Project Management of global Packaging & distribution.

  • Operations Manager, Global Clinical Supplies EU

    March 2008 --- April 2010
    management of the eu central warehouse, taking care of the storage and distribution of products for Clinical trials all over the eu & middle east, part of the global gcs department, coordinating the Packaging and distributing products for Clinical trials all over the world. expertise in refrigerated shipments, close tracking of all shipments until arrival and general Project Management of global Packaging & distribution.

  • QA Manager Benelux

    October 2006 --- March 2008
    ensure the quality and the release for over-the-counter (otc) products for novartis'products for the benelux. quality manual implementation & update. third party and internal quality agreements and audits. complaints and deviation handling.

  • GCSU Manager

    January 2003 --- August 2006
    manage the department taking care of the Packaging of drug for Clinical trials.

  • Clinical Trial Coordinator (CTC)

    March 2000 --- January 2003
    coordinate the Packaging of drug for Clinical trials directly with the (internal) client. translate their wishes to the Packaging department and/or the contractor.

  • IVRS Project Assistant

    August 1997 --- March 2000
    supporting the client with the ivrs (interactive voice response system) system of covance. making inventory reports, Interim report, tracing up problems,...

  • Assistant Analyst

    August 1996 --- June 1997
    develop Analytical methods for drugs from international Pharmaceutical clients which were administered to subject in the nearby Phase I clinic. once developped, the method was used to analyse all the plasma samples from those subjects.

Personality

BrightOwl Assessment :
Reaction to stressApproachabilityPerspectiveCuriosityInterest in knowledgeAuthenticityKindnessDependabilityImpulse commandAnger commandAttention to detail
Self Assessment :
SociabilityApproachabilityCuriosityInterest in knowledgeTrustAuthenticityIndependenceDiligenceAdaptability

Knowledge

BrightOwl Assessment :
MultilingualEnglishfredutchFrenchProject ManagementManaging Clinical Trial SuppliesPharmaceutical IndustryLife SciencesQuality Assurance (QA)pharmacologyscience
Self Assessment :
MultilingualLife SciencesDrug development processRandomization and blindingICH GCP guidelinesProject ManagementManaging Clinical Trial SuppliesGood Clinical Practice (GCP)CROPharmaceutical IndustryClinical trialsFrenchEnglishdutch
LinkedIn Assessment :
Clinical trialsPharmaceutical IndustryClinical researchQuality Assurance (QA)PharmaceuticsGMPLogisticsGCPSOPClinical DevelopmentValidationRegulatory affairsProject ManagementRegulatory RequirementsFDAClinical SuppliesPackagingmanagementCAPAClinical monitoringPharmacovigilanceoncologyChange Control21 CFR Part 11ICH-GCPLifesciencesRegulatory submissionsProcess OptimizationIVRTechnology transferBiotechnologyElectronic Data Capture (EDC) Therapeutic Areaspeople managementClinical Trials LogisticsEmotional IntelligenceInternational TradeGood Laboratory Practice (GLP)VaccinesBiopharmaceuticalsGXPIVRSClinical Supply Chain OptimizationAnnex 13Pharmaceutical WarehousingLabelingImport/ExportProblem SolvingGood Distribution PracticeCRO

Skills and Expertise

BrightOwl Assessment :
Administer, maintain and co-ordinate the logistical aspects of clinical trialsSupervise and/or distribute trial supplies, including the trial drug Order bulk drug and clinical trial drug suppliesCoach and provide guidance to clinical staff.Direct co-workers to achieve resultIdentify and provide training to trial team and associated stafflifescienceWork collaboratively with the other members of the clinical research team Understand and react to the internal politics and demands of the companyPlan work to meet objectives and deadlines
Self Assessment :
Administer, maintain and co-ordinate the logistical aspects of clinical trialsCoach and provide guidance to clinical staff.Design a tracking systemDevelop and maintain tracking systemsDistribute study supplies, including study drugsLiaise with professionals in other divisions of the company as requiredOrder bulk drug and clinical trial drug suppliesPlan work to meet objectives and deadlinesProvide financial reports to the senior managementSupervise and/or distribute trial supplies, including the trial drug Work collaboratively with the other members of the clinical research team R&Dlifescience

Education

  • Master in Pharmaceutical Science from KULeuven in 1996
  • Master in Chemistry from KULeuven in 1993
  • High School Degree in Mathematics and Sciences from Sint Albertus College in Haasrode in 1989

Languages

BrightOwl Assessment:
Self Assessment:
Afrikaans
Elementary Proficiency
Dutch
Native
French
Native
English
Full Proficiency
German
Elementary Proficiency

Work Preferences

  • Notice Period:
    12 weeks
  • Work From Home:
    No
  • Work Regime:
    Permanent position :    100% FTE
    BrightOwl employee :    100% FTE
  • International:
    Yes

Area / Region

Wavre, Belgium

Others

Driving License
  • Yes

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