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Experiences

Past Experience

  • Regional Country Study Manager Anderlecht, Belgium
    May 2015 --- November 2015

    Phase I, II - III    Oncology:  hematology,  gastric cancer,  breast cancer

     

    • Lead clinical trials in West European Supporting Markets
    • Oversee monitoring activities and regulatory submissions
    • Ensure compliance with SOPs, ICH-GCP, Local regulations
    • Manage Country budget & forecasts

  • Senior Lead Global Trial Manager Beerse, Belgium
    March 2011 --- February 2015

    2013 - 2014   Based in Los Angeles, CA US

     

    Phase II - III    Oncology (MM, MCL) – Infectious Diseases (tuberculosis – pneumonia)

    • Lead global clinical trials from set up to close out
    • Manage CROs conducting outsourced trials
    • Coordinate global feasibility and site selection
    • Provide training to country managers, CRAs and site staff
    • Lead study management team and oversee external vendor groups
    • Manage & monitor patient recruitment at a global level
    • Manage country & vendor forecasts; ensure alignment with global budget

  • Cluster Study Manager Anderlecht, Belgium
    August 2009 --- March 2011

    Phase III - IV      Urology: Lower Urinary Tract Symptoms – Benign Prostatic Hyperplasia

     

    • Manage and train CRAs in Belgium & France
    • Ensure study conduct within timelines and local budget
    • Global reporting & budgeting
    • Compliance with SOPs, ICH-GCP, Local regulations
    • Feasibility and site selection

  • Sr Clinical Research Associate Diegem, Machelen, Belgium
    October 2007 --- August 2009

    Phase I/IIab- III   Oncology: advanced solid malignancies, bladder & breast cancer

     

    • Conduct feasibility & perform site selection
    • Train CRAs and perform co-initiation visits
    • Coordinate submission activities (HA/ECs)
    • Monitoring activities until close out: ensure safety reporting, protocol compliance, quality of data, data cleaning - within timelines etc.

  • Global Study Manager Rixensart, Belgium
    January 2007 --- October 2007

    Phase III  Vaccines pediatric studies

     

    • Manage Global Clinical trials from set up to close out
    • Manage & lead study teams and CRAs
    • Ensure trial conduct in accordance to all SOPs, ICH-GCP and regulatory regulations
    • Liaise with operational and clinical team to ensure timely development of protocol, ICF, eCRF, Monitoring guidelines, drug development etc.

  • Clinical Research Associate (CRA) Genval, Belgium
    January 2005 --- January 2007

    Phase III, IV     Urology – Benign Prostatic Hyperplasia

     

    • Train investigators on protocol & biopsy procedures (exam)
    • Monitoring visits: SAE reporting & follow up, Query handling, Drug accountability
    • Management of investigator contracts
    • Perform amendment submission and obtain approvals (HA/ECs)
    • Participate at Audits and follow-up on CAPA completions

Knowledge

Self Assessment :
International Project Managementpeople management Biochemistry Cell biology Negotiation Phase I R&DBudget ManagementBusiness Process ImprovementBusiness PlanningBusiness StrategyCancerChange ManagementChemistryClinical DevelopmentClinical monitoringClinical operationsClinical Study DesignClinical study reportsClinical trial audits and inspectionsClinical trial designClinical Trial Management System (CTMS)Clinical trial managementClinical Trial SuppliesCoachingCommunication SkillsCompetitive AnalysisCross-functional team leadershipData AnalysisData cleaningDesigning case report formsDeveloping Clinical Trial ProtocolsDiagnosticsDrug Safety and PharmacovigilanceElectronic Data Capture (EDC) FDAEnglishGood Laboratory Practice (GLP)Good Manufacturing Practice (GMP)Contract negotiationCRF designEthics submission and approval processEvent ManagementHealthcare ManagementInfectious diseasesInflammationLife SciencesLeadershipMedical ImagingoncologyOperations ManagementVirologyVaccinesUrologyProject CoordinationPhase IIPhase IIIPhase IVBudgetingData ManagementDrug DeliveryDrug DiscoveryDrug InteractionDrug safety assessmentGastroenterologyGeneral MedicineHospitalsIn VitroManagement ConsultingMicrobiologyMultilingualNutritionOutsourcingPharmaceutical DevelopmentPharmacovigilancepharmacologyQuality Management System (QMS)Registration of the productRegulatory affairsRegulatory ComplianceSafety concerns (such as therapeutic ratio with respect to possible adverse effects)Standard Operating Procedure (SOP)Time ManagementSupervising CRAsStudy protocolsSupply ChainToxicologyTrainingInformed Consent Documents
LinkedIn Assessment :
Clinical trialsCTMSGCPICH-GCP

Skills and Expertise

Self Assessment :
leadership Analytical skills Assure medical quality Design case record forms Develop clinical trial protocols Develop protocols Guide studentsAct as the main line of communication between the sponsor and the investigatorAdjust processes Assess product quality issuesAssess business and scientific ethicsAssess adverse reactionsArchive trial documentation and correspondence.Written presentationWrite clinical evaluation reportsUpdate Clinical Trials Management System (CTMS) Translate strategy into operational plansTranslate customer needs into analytical study proposal/protocolTranslate clinical research concepts into specific objectivesTranslate protocol into packaging and labeling requirementsTrain StaffTrain off site staffSite managementShipment of biological specimenSetup of research equipmentSolve problemsSelect sitesSelect investigatorsSelect contractors Search literature on clinical trialsAdjust processes and methodsAdjust methodsAdminister, maintain and co-ordinate the logistical aspects of clinical trials Create SOPsAdminister logisticsAdvise on strategyAnalyse growth / improvement potentialApprove Label Master SheetApprove monitoring reportsApprove patient informationApprove queriesApprove suitability of patient information and consent documentsArchive documentationArchive study documentsApprove drug supply Approve consent documentsAssess site feasibilityAssess subject safetyCollaborate with medical teamCollaborate with PI and institution to respond to any audit findings and implement-approved recommendations.collaborate in research projects at universitiesCollaborate with principal investigatorCollaborate with project teamCollect financial data from hospitalsCommunicate effectively on different company levelsCommunicationConduct maintenance visitsConduct site initiationConduct the trialConfirm protocol complianceCoordinate with the ethics commiteeData verificationData codingDesign case record form (CRF)Design clinical presentationDesign data collection systemsDesign data reporting systemsIdentify and provide training to trial team and associated staffIdentify growth / improvement potentialIdentify investigatorsIdentify market opportunitiesInformed consent processInitiate clinical trials Interpret analytical resultsLead studiesManage vendor budgetsMonitor dataMonitor sales performancePlan work to meet objectives and deadlinesPrepare external auditsPreparing referral lettersproject managementProvide benefit risk assessmentReview vendor reportsReview study protocolsSerious Adverse Event (SAE) ReconciliationSet up a clinical study Use content management systemsDesign tracking system

Education

  • Orthomolecular medicine in Medicine from ICZO Lier in 2016
  • Master in Biomedical Science from Katholieke Universiteit Leuven in 2004

Languages

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

Work Preferences

  • Work From Home:
    No
  • International:
    Yes

Area / Region

Belgium

Others

Driving License
  • Yes