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Experiences

Current Experience

  • Clinical Project Manager (CPM)

    Mechelen, Belgium
    Since November 2013

Skills and Expertise

Self Assessment :
Develop clinical trial protocols Interact with physicians Molecular Diagnostics Monitor a clinical study Report data Search literature on clinical trials Write protocolsAct as the main line of communication between the sponsor and the investigatorApprove monitoring reportsAssess site feasibilityAssist study siteAssist with site trainingAttend at steering committee meetingsAttend investigator meetingAttend seminarsAttend seminars, courses and meetings within and outside the companyBuild trial master file (TMF)budgeting of R&D activitiesCalculate timelines for conducting and completing the trialClinical data collectionCoach clinical staffcollaborate in research projects at universitiesCollaborate with medical teamCollaborate with principal investigatorCollaborate with PI and institution to respond to any audit findings and implement-approved recommendations.Collect patient forms and questionnairesCommunicate effectively on different company levelsCommunicate with investigatorConduct close-out visitsConduct literature searchesConduct maintenance visitsConduct site initiationCreate clinical documentsCreate clinical project documents according to the protocolCreate standard operating procedure (SOP)Create study documents Design case record forms Develop protocolsCoach staffData verificationDesign case record form (CRF)Design exclusion criteriaDesign inclusion criteriaDesign trial master file (TMF)Develop ICH/GCP compliant processesDevelop training materialsEnsure good clinical practice (GCP)Establish relationships with Key Opinion LeadersEthics committee submissionsIdentify investigatorsInitiate clinical trials Interact with KOLLead studiesMaintain clinical evaluation reportsManage clinical suppliesManage study budgetManage trial master file (TMF)Manuscript reviewNegotiate budget Oral presentationOrganise meetingsPrepare final reportProtocol managementRead medical literature to maintain current awareness and knowledgeResolves queriesReview clinical study reportsReview dataReview exclusion criteriaReview inclusion criteriaReview monitoring reportsReview reportsSet up a clinical studySite managementSolve problemsStudy-related documentsTrain Staffwrite and maintain clinical evaluation reports

Education

  • Master in Pharmaceutical Sciences from KuLeuven in 1983

Languages

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

Work Preferences

  • Notice Period:
    12 weeks
  • Locations I am interested in:
    Brussels, Belgium East Flanders, Belgium Flemish Brabant, Belgium
  • Work From Home:
    Yes, 2 to 3 days per week
  • Work Regime:
    Permanent position :    75-80% FTE
  • International:
    Yes

Area / Region

Dilbeek, België

Others

Driving License
  • Yes

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