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Experienced Clinical Development Consultant with over 20 years of experience in the pharmaceuticals and biotech industry.
• Profound understanding of clinical research (healthy volunteers up to phase 3 in various indications)
• Solid knowledge of regulations (EU and US)
• Project Management Skills
• Vendor selection, oversight and CRO management
• Advanced GCP knowledge
• Experience with systemic GCP inspection
 

Experiences

Current Experience

  • Clinical Development and Clinical Operations Consultant

    Belgium
    Since June 2018
    Clinical

    Strategically and operationally support to small biotech companies in setting up and executing clinical programs/studies.

Past Experience

  • R&D Director, Clinical Development Zoersel

    January 2018 --- June 2018
    Due Diligence

  • Clinical Program Leader Zoersel, Belgium

    May 2016 --- December 2017
    Due Diligence

  • Clinical Project Manager Zwijnaarde, Ghent, Belgium

    February 2008 --- April 2016
    Clinical Development

  • Clinical Project Leader Brussels, Belgium

    July 2004 --- January 2008
    Phase 2

  • Clinical Research Associate (CRA)

    October 1997 --- June 2004
    CRA

Personality

Self Assessment :
AdaptabilityAnalytical thinkingAttention to detailAuthenticityCollaborationCommunicativeCritical thinkingEfficiencyFlexibilityInterest in knowledgeProactivityProblem solvingResult OrientedTrustWillingness to compromise

Knowledge

Self Assessment :
Negotiation Phase I R&D21 CFR Part 11Writing Study Procedures and SOPsUnderstanding of regulatory guidelinesAdverse Events (AE)BiotechnologyBudget ManagementBudget NegotiationCancer ResearchClinical Data ManagementClinical DevelopmentClinical monitoringClinical operationsClinical researchClinical Study DesignClinical study reportsClinical SuppliesClinical trial audits and inspectionsClinical trial budgetingClinical trial designClinical trial managementClinical Trial Management System (CTMS)Clinical Trial SuppliesClinical trialsCompliance with regulationsComplianceContract negotiationCRFCRF designCROCross-functional team leadershipCTMSDeveloping Clinical Trial ProtocolseCRFeCTDEDCEfficacy trialsEMAEnglishEthics submission and approval processFDAGene therapyGood Clinical Practice (GCP)ICH guidelinesINDInfectious diseasesInformed Consent DocumentsInternational Project ManagementInternational RelationsKOL managementLife SciencesManaging Clinical Trial SuppliesMicrosoft OfficeMicrosoft PowerpointMicrosoft WordMicrosoft ExcelMonitoring Study ProgressMultiple dose tolerance studyNew Drug Application (NDA)oncologyOperations ManagementOutlookPatient recruitmentPharmaceuticalsPhase IPhase IIPhase IIIPreclinical developmentPresentation SkillsProblem SolvingProgram ManagementProject ManagementProject CoordinationRegulatory affairsRegulatory ComplianceRegulatory RequirementsStandard Operating Procedure (SOP)Start-upsTeamworkTime ManagementTraining

Skills and Expertise

Self Assessment :
Build and manage the Trial Master File (TMF) Create SOPs Develop clinical trial protocols Interact with physicians Monitor a clinical study Search literature on clinical trialsAdverse event reportingApprove consent documentsApprove monitoring reportsApprove patient informationArchive trial documentation and correspondence.Attend at steering committee meetingsAttend investigator meetingAttend seminars, courses and meetings within and outside the companyAttend steering committeeBuild trial master file (TMF)Calculate trial timelinesCoach clinical staffCollaborate with medical teamCollaborate with principal investigatorCommunicate effectively on different company levelsCommunicate with investigatorCommunicate with sponsorConduct close-out visitsConduct literature searchesConduct site initiationConduct studiesConfirm protocol complianceControl protocol versionsControl studiesCoordinate logisticsCoordinate projectscoordinating research projectsCreate clinical documentsCreate clinical project documents according to the protocolCreate SOPsCreate study documentsDesign information leafletDesign study documentsDesign subject consent formDevelop study budgetDevelop study timelinesDevelop supply plansDevelopment of Pharmacy manualEnsure good clinical practice (GCP)Establish relationships with Key Opinion LeadersEvaluate protocolsGastrointestinal diseasesIdentify investigatorsIdentify sitesImplement Quality Management System (QMS)Indentify clinicians to conduct clinical trialsInitiate clinical trials Interact with CROsInteract with KOLInteract with nursesInteract with ethics committeeInteract with pharmacistsInteract with physiciansInteract with statisticiansInterpret research resultsLead studieslifescienceManage contractors Manage multiple projectsManage research projectsManage study budgetManage vendor budgetsOral presentationOrganise meetingsOrganise steering committeePatient recruitmentPlan work to meet objectives and deadlinesPlanning clinical studiesPrepare investigator brochuresPrepare manuscriptPrepare regulatory documentsPrepare responses to health authority queriesPresent clinical resultsPresent data at congressproject managementProtocol managementProvide trainingRegulatory submissionsRegulatory documentationReview clinical study reportsReview monitoring reportsReview protocolsReview quality control activitiesReview quality policiesReview reportsReview study protocolsSearch literature on clinical trialsSelect investigatorsSelect sitesSet up a clinical studySet up research projectsSolve problemsStudy-related documentsUnderstand protocolsWork collaboratively with the other members of the clinical research team Work cross-functionally

Education

  • Master in Pharmacy from KULeuven in 1996

Training and Certification

  • GCP trainings in 2019 Training
  • Languages

    BrightOwl Assessment:
    Self Assessment:
    Dutch
    Native
    French
    Full Proficiency
    English
    Professional Proficiency
    German
    Elementary Proficiency
    Spanish
    Elementary Proficiency
    Italian
    Elementary Proficiency

Work Preferences

  • Positions I am interested in:
    Clinical Development Consultant Clinical Operations Manager Clinical Project Leader Clinical Project Manager (CPM) Clinical Research Consultant Project Manager Senior Consultant Senior Clinical Project Manager (CPM) Global Clinical Project Manager (GCPM, GTM)
  • Positions I am NOT interested in:
    Clinical Research Associate (CRA)
  • Locations I am interested in:
    Belgium
  • Work From Home:
    Yes, 3 Days
  • Work Regime:
    BrightOwl freelancer :    20 Hours per week
  • International:
    Yes
  • Availability:
    Jan 2020 : 50%
    Feb 2020 : 50%
    Mar 2020 : 50%
    Apr 2020 : 50%
    May 2020 : 50%
    Dec 2019 : 50%

Publications

    Expert has 1 publications (Will be avalible with full profile)

Area / Region

Belgium

Others

Driving License
  • Yes

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