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Summary

Clinical Research Professional with a broad experience in international clinical research in pharmaceutical/nutraceutical industry and medical devices.

Experiences

Current Experience

  • Global Director Project Management Ghent, Belgium
    Since September 2015

     

Past Experience

  • Director Operational Excellence
    June 2014 --- September 2015

  • Director Vendor Management
    January 2012 --- June 2014

  • Managing Director Benelux
    October 2010 --- June 2014

  • Managing Director
    October 2010 --- February 2013

  • General Manager at IATEC France, Director Business Development IATEC Corporate
    January 2009 --- September 2010

  • Clinical Research Operations Manager
    March 2007 --- January 2009

  • European Clinical Studies Manager
    January 2005 --- January 2007

  • Senior International Project Manager
    January 2002 --- January 2005

  • International Protocol Manager
    January 2001 --- January 2002

  • International Project Manager
    January 2000 --- January 2001

  • National Trial Manager
    January 1992 --- January 2000

  • Bachelor Nursing
    January 1982 --- January 1992
    Intensive Care and Emergency Room Nursing

Personality

Self Assessment :
Creative thinkingService orientedTrustPerspectiveProblem solvingInnovative thinkingFlexibilityEfficiencyCritical thinkingOptimism

Knowledge

Self Assessment :
GCPGood Clinical Practice (GCP)Human ResourcesICH GCP guidelinesICH-GCPINDInfectious diseasesInformed Consent ProcessInternal medicineInterpret clinical trial resultsInterpret clinical trial resultsKnowledge of the drug development processKOL managementManaging Clinical Trial SuppliesMedical budget managementMedical DevicesNegotiationNephrologyNeurologyOperating RoomOrthopedic surgeryPatient Follow UpPatient Screening and RecruitmentPediatricspeople managementPharmaceutical IndustryPhase IIPhase IIIPhase IVPrinciples and ethics of clinical researchProblem-solving methods and troubleshootingPsychiatryQuality Assurance (QA)Quality of Life (QoL) outcomesRandomization and blindingRandomization SystemsSerious Adverse Event (SAE)SOPStem cell researchSupervising CRAsTeam LeadershipInformed Consent DocumentsWriting Study Procedures and SOPs NegotiationCAPACardiologyCardiovascular diseasesClinical DevelopmentClinical monitoringClinical operationsClinical researchClinical Study DesignClinical trial budgetingClinical trial audits and inspectionsClinical trial managementClinical trialsContract negotiationCross-functional team leadershipDermatologyDrug development processEDCElectronic Data Capture (EDC) EMAEnglishEthics submission and approval processFDA
LinkedIn Assessment :
Clinicalpeople managementInternational Business ExperienceMedical DevicesClinical trialsClinical researchPharmaceuticalsClinical DevelopmentInfectious diseasesCROLife SciencesContract negotiationGCPBudgetingOutsourcingBusiness StrategyStrategic PlanningClinical trial managementOperations ManagementCTMSBusiness DevelopmentLifesciencesVendor ManagementCardiologyClinical monitoringICH-GCPSOPNeurologyClinical operationsLine ManagementOrthopedicPharmaceutical IndustrymanagementBiotechnologyRegulatory submissionsPharmacovigilanceBudgetsRegulatory affairsVaccinesSOP

Skills and Expertise

Self Assessment :
Create SOPs Develop clinical trial protocols Interact with nurses Interact with physicians Interpret dataAdjust processes and methodsApprove monitoring reportsApprove patient informationAssist study siteAssist with proceduresAttend investigator meetingAttend seminarsbudgeting of R&D activitiesCalculate trial timelinesCalculate process efficiencyBuild trial master file (TMF)Capture data on source documentsClinical data collectionCoachCoach clinical staffCoach staffCollaborate with medical teamCollaborate with principal investigatorCollaborate with project teamCommunicate with investigatorCommunicate with sponsorCollect financial data from hospitalsComplete case report form (CRF)Consequences analyses of trial designCoordinate ethics committeeCoordinate with the ethics commiteecoordinating research projectsCreate SOPsCreate clinical documentsCreate standard operating procedure (SOP)Creates a collaborative team environmentDesign data collection systemsDesign data reporting systemsDesign information leafletDesign tracking systemDesign trial master file (TMF)Develop clinical strategyDiscuss treatments with investigatorEnsure data consistencyEnsure data integrityEnsure good clinical practice (GCP)Estimate subject complianceEthics committee applicationEvaluate post-marketing surveillance studyEvaluate protocolsFeasibility analysis of proposed trial designFinancial administrationFinancial reportsFollow-up of external auditsFollow-up of internal auditsGeneral office managementGuide staffIndentify clinicians to conduct clinical trialsIdentify investigatorsInitiation visitInteract with CROsInteract with ethics committeeInteract with nursesInteract with pharmacistsInteract with physiciansInteract with pre-clinical scientistsInterpret dataLiaise with doctorsLiaise with research teamMaintain clinical evaluation reportsMaintain Quality Management System (QMS)Manage clinical trial files/documentsManage Clinical Trial Management System (CTMS) Manage contractors Manage projects resourcesManage study budgetManage subject consent formManage trial master file (TMF)Manage vendor budgetsmanaging a small teamMonitor a clinical studyNegotiate budget NegotiationObserve trends in dataOffice managementOral presentationOrganise meetingsPatient liaisonPatient recruitmentPersuade clinicians to conduct clinical trialsPlanning clinical studiesPrepare internal auditsPresent clinical resultsPresent data at congressProtocol managementProvide benefit risk assessmentQuality control processReport serious adverse events (SAE)Report non-compliance incidentsRespond to audit findingsReview data interpretationReview exclusion criteriaReview inclusion criteriaReview clinical study reportsReview quality control activitiesReview quality policiesSchedule trial visitsScheduling trial visitsScreen patientsSearch literature on clinical trialsSelect contractors Select investigatorsSerious Adverse Event (SAE) ReconciliationSet up a clinical studySet-up quality policiesStudy execution planStudy-related documentsSupervise clinical monitorsTrain off site staffTrain on site staffWritten presentation

Education

  • in People Management from Vlerick Leuven-Gent Management School in 2008
  • Marketing Consultant in Marketing, Commercial consultant from CMO Leuven in 1999
  • Clinical Research Monitor in Clinical Research Monitor from Pharma Networks Training Center in 1993
  • Bachelor in Nursing from Hogeschool Antwerpen in 1981

Languages

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

Work Preferences

  • Work From Home:
    No
  • Work Regime:
    Permanent position
  • International:
    Yes

Area / Region

Destelbergen, Belgium

Others

Driving License
  • Yes