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Summary

 

 

Sr Clinical Research Associate, for more than 20 years experiences in monitoring tasks including initiation, monitoring and close-out visits in more than 9 European countries according to the Good Clinical Practice guidelines. Unblinded CRA experiences as well and Ethics committee submisson in European  countries. Since the last 5 years I was also in charge of training and supervision (revision of monitoring visit report and monitoring tasks) for CRAs, management of  team workload and study site evaluation, development of worksheets and guidelines to facilitate the adherence to the protocol, translation of studies documents etc

Experiences

Current Experience

  • Sr CRA II Bruxelles, Belgique
    Since January 2009

     

     

    ·        Sr Clinical Research Associate, more than 20 years experiences in monitoring tasks including initiation, monitoring and close-out visits in more than 9 European countries according to the Good Clinical Practice guidelines. Unblinded CRA experiences as well.

     

    Ethics committee submisson in Belgium, Luxembourg, Netherlands, France, Italy, Spain, Austria, Germany and UK from Phase 1 to Phase 4.

     

    Management of the contract between the sponsor and the investigator and payment follow-up.

     

    ·        Participation in several Clinical studies in following aeras: Oncology (phase 2, 3 and 4) , Hematology (phase 2, 3 and 4) endocrinology (phase 3 and 4) and Neuropediatry (phase 4) for Novartis pharma, Rhumatology and ostoporosis (phase 1 to 4) for BMS and MSD ,Menopause (phase 1, 2 3 and 4) for MSD, Eli Lilly and Whyeth, Neuromodulation (phase 3 and 4) for St Jude Medical, Surgery for GERD (phase 1 and 2 + SHAM studies) for EndogastricSolutions, obesity.(phase 2) for US GI, and Gastro-enterology (phase 2) for SpectraScience, inc

     

     

     

  • Clinical Research Manager Bruxelles, Belgique
    Since January 2008

     

     

     

    ·        Clinical Project Manager for Medical Device companies from phase 1 till phase 4 studies, this function consist in Drafting protocol, CRFs and SOPs in accordance with regulation in this aera and countries specific, Key opinion leaders contacts, organization of Investigator’s meeting, presentation during scientific meeting, participation in international congresses, data management and pre-analysis of results, budget management, training and supervision (revision of monitoring visit report and monitoring tasks) for CRAs, management of work load for CRAs and study site evaluation, development of worksheets and guidelines to facilitate the adherence to the protocol, translation of studies documents etc

     

     

Past Experience

  • Sr CRA II Ghent, Belgique
    May 2005 --- December 2007

     

     

    ·        Initiate sites for clinical studies

     

    ·        Collect, verify, and monitor clinical data from Phase 1 to Phase 4 in Belgium, Italy, and Germany according to the Good Clinical Practice guidelines; pre-analysis of results

     

    ·        Follow-up of studies from screening to closeout visits, which includes the planning and assistance during patient examinations for Phase 1 and 2

     

    ·        Organization of investigator’s meetings; review study protocol at ethics committee and at the Ministry for Health

     

    ·        Drafting of protocols, Case Report Forms, and guidelines for study coordinator

     

     

     

  • Study Coordinator on site Bruxelles, Belgique
    June 1996 --- April 2005

     

     

    Study Coordinator:  (osteoporosis and menopause)

     

    ·        Management of Case Report Forms, including Adverse Event and Serious Adverse Event Forms

     

    ·        Schedule patient follow-up visits

     

    ·        Monitoring visits with Clinical Research Associate

     

    ·        Communications between Clinical Research Associate, Contract Research Organization, and pharmaceuticals companies

     

    ·        Pre-analysis of results

     

     

     

Personality

BrightOwl Assessment :
CoordinationDiligenceCollaborationEfficiencyAttention to detailDependabilityOrganizationCharmAuthenticityCuriosityPerspectiveAssertivenessReaction to stressProblem solving
Self Assessment :
Adaptability

Knowledge

BrightOwl Assessment :
Medical DevicesoncologyPhases of clinical development (phase I to IV)Clinical monitoringClinical trial budgetingClinical trial managementClinical trialsClinical DevelopmentClinical Study DesignClinical trial designClinical operationsGood Clinical Practice (GCP)Understanding of regulatory guidelines
Self Assessment :
Medical devices Phase ICancerClinical DevelopmentClinical monitoringClinical operationsClinical researchClinical Study DesignClinical trial managementClinical trialsEndocrinologyGastroenterologyGCPFDAHematologyICH GCP guidelinesoncologyPatient Screening and RecruitmentPhase IIPhase IIIPhase IVPhysical medicine and rehabilitationSafety trials

Skills and Expertise

BrightOwl Assessment :
Analyze data Create SOPsClinical data collectionCoachCollaborate with principal investigatorCollaborate with project teamCommunicate with investigator Monitor a clinical studyConduct site initiationConduct the trialCoordinate with the ethics commiteeCreates a collaborative team environment Analyze dataData validationDesign clinical trialDesign protocolDesign studyDirect co-workersEnsure good clinical practice (GCP)Ethics committee submissionsConduct site initiationInteract with CROsInteract with ethics committeeInterpret datalifescienceLiaise with research teamManage study budget Monitor a clinical studySchedule trial visitsSolve problems
Self Assessment :
Create SOPs Develop clinical trial protocols Monitor a clinical studyApprove monitoring reportsAssess site feasibilityClinical data collectionCoach clinical staffCollaborate with principal investigatorCollaborate with project teamCommunicate with investigatorCommunicate with sponsorConduct close-out visitsConduct monitor visitsConduct site initiationConduct research at universitiesContract approvalCoordinate with the ethics commiteeData analysisData verificationDesign clinical trialDesign protocolDesign studyFacilitate sponsor monitoring visitsMaintain clinical evaluation reportsMonitor a clinical studyNegotiate budget Negotiate protocol details Read medical literatureSelect investigatorsSolve problems

Education

  • Bachelor in Physiotherapy from ISCAM in 1989

Training and Certification

  • GCP in 2014 Certification
  • Radioprotection in 1999 Certification

Work Preferences

  • Notice Period:
    1 week
  • Work From Home:
    Yes, 1 to 5 days per week
  • Work Regime:
    BrightOwl freelancer :    38h/week Hours per week
  • International:
    Yes

Publications

    Expert has 2 publications (Will be avalible with full profile)

Area / Region

Bruxelles, Belgique

Others

Driving License
  • Yes