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Experiences

Current Experience

  • Freelance Clinical Research Professional

    Geel, Belgium
    Since January 2011

    Freelance Clinical Research Professional: start up, monitoring and managing Medical Device studies (neuromodulation, Vascular disease, orthopaedics).

    used to work in a start up company environment, used to work in european environment.

    field clinical support: surgeon trainings and Technical Support in operation theatres, europe.

    experienced study Coordinator at clinical site.

    Freelance Clinical Research Professional: start up, monitoring and managing Medical Device studies (neuromodulation, vascular disease, orthopaedics).

    Used to work in a start up company environment, used to work in European environment.

    Field clinical support: surgeon trainings and technical support in operation theatres, Europe.

    Experienced study coordinator at clinical site.

Past Experience

Personality

Self Assessment :
FlexibilityDiligenceCreative thinkingProblem solving

Knowledge

Self Assessment :
Medical devicesBudget ManagementBudget NegotiationCardiovascular diseasesClinical operationsClinical Study DesignClinical trial managementDesign and tracking systemsEthics submission and approval processGood Clinical Practice (GCP)Interventional RadiologyOperating RoomPatient Screening and RecruitmentProject ManagementTechnical SupportSupervising CRAsStart-upsSafety reportingRegulatory submissions

Skills and Expertise

Self Assessment :
Build and manage the Trial Master File (TMF) Design case record forms Develop clinical trial protocols Guide students Interact with nurses Monitor a clinical studyAdverse event reportingAttend steering committeeAttend investigator meetingCoachAssist with proceduresCollaborate with principal investigatorCollaborate with project teamCreate study documentsDevelop study budgetEnsure good clinical practice (GCP)Ethics committee submissionsFollow-up of internal auditsInteract with CROsIdentify investigatorsManage Clinical Trial Management System (CTMS) Manage contractors Manage study supplyOrganise meetingsPrepare internal auditsPrepare regulatory documentsPresent clinical resultsProvide trainingRead medical literatureSelect contractors Set up a clinical studyShipment of biological specimen

Education

  • Bachelor in nursing from Sint Aloysius, Lier in 1994

Languages

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

Work Preferences

  • Notice Period:
    1 week
  • Positions I am interested in:
    Clinical Research Consultant Clinical Project Manager (CPM)
  • Locations I am interested in:
    Belgium Germany Netherlands
  • Work From Home:
    Yes, 5 to 0 days per week
  • Work Regime:
    BrightOwl freelancer :    8 Hours per week
  • International:
    Yes

Area / Region

Geel, België

Others

Driving License
  • Yes

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