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Summary

experience in conducting Clinical trials since 2002. •start up and manage international Phase I-iv Clinical trials in various areas.(urology, oncology, Dermatology, vaccinology, Endocrinology, gastro enterology, Rheumatology, ...) •expertise in Investigator driven trials/ ist / non commercial trials •Project Management, budget control, perform feasibilities, submissions to ec/ca, monitoring.. •science)" rel="nofollow">Protocol, icf, crf writing

Experiences

Current Experience

  • Freelance Clinical Trial Specialist


    Since October 2009
    manage international Investigator driven trials in various scientific areas manage and monitor international Phase I-iv Clinical trials in various areas.(urology, oncology, Dermatology, vaccinology, Endocrinology, gastro enterology...) start up and manage Investigator driven trials Project Management, budget control, perform feasibilities, submissions to ec/ca, monitoring.. science)" rel="nofollow">Protocol, icf, crf writing Manage international Investigator driven trials in various scientific areas Manage and monitor international phase I-IV clinical trials in various areas.(urology, oncology, dermatology, vaccinology, endocrinology, gastro enterology...) Start up and manage investigator driven trials Project management, budget control, perform feasibilities, submissions to EC/CA, monitoring.. Protocol, ICF, CRF writing

  • Freelance Clinical Project Manager

    Gent
    Since September 2008
    • Expertise in start up and management of  investigator driven and non commercial trials

    • Experienced in start up and management of phase II, III, IV trials

    • Project management, budget control, perform feasibilities, submissions to EC/CA, monitoring, vendor selection,

    • Contract negotiation with involved partners (labs, CRO, PI,...)

    • Protocol, ICF, CRF writing

    • Manage and monitor international phase II-IV clinical trials in various areas.(urology, oncology, dermatology, vaccinology,  endocrinology, gastro enterology, neurology...)

    • Monitoring of a Medical device trial in pneumology

Past Experience

  • lead CRA / Junior CPM Ghent

    July 2002 --- June 2008
    tasks performed at different levels of responsibility: inform and motivate project team, design science)" rel="nofollow">Protocol, crf, icf etc, provide strategic and operational support, co-monitoring / monitoring trial sites, assist in investigational site and CRO Auditing, Research in scientific literature.

  • Clinical Research Associate (CRA)

    October 2005 --- September 2007

  • Junior Clinical Project Leader

    September 2003 --- September 2005

  • Trial Assistant Ghent

    July 2002 --- August 2003
    tasks performed at different levels of responsibility: inform and motivate project team, design science)" rel="nofollow">Protocol, crf, icf etc, provide strategic and operational support, co-monitoring / monitoring trial sites, assist in investigational site and CRO Auditing, Research in scientific literature.

  • Physical Therapist

    January 2000 --- January 2002
    ergonomic Training, design interactive backschool website

  • Physical Therapist

    January 1999 --- January 2000
    guide patients with back disorders (theoretical Training, cybextesting, design individual Training programs, aqua-gym Training

  • Physical Therapist

    January 1997 --- January 1997
    Volunteer Physical Therapist for children with cerebral palsy

Personality

Self Assessment :
IndependenceOptimismInterest in knowledgeApproachability

Knowledge

Self Assessment :
DermatologyEndocrinology and metabolismGastroenterologyMedical oncology Understanding of regulatory guidelinesNeurologyPhysical medicine and rehabilitationPulmonary diseasesClinical trial designRandomization and blindingQuality of Life (QoL) outcomesInformed Consent DocumentsDeveloping Clinical Trial ProtocolsDesigning case report formsEthics submission and approval processICH GCP guidelinesWriting Study Procedures and SOPsPatient Screening and RecruitmentManaging Clinical Trial SuppliesProject ManagementClinical trial budgetingPhase IIPhase IIIPhase IVLegal Considerations: Contracts and Indemnity

Skills and Expertise

Self Assessment :
Act as the main line of communication between the sponsor and the investigatorAdvise company lawyers, marketers and non-medical scientists on medical perspectives Approve suitability of patient information and consent documentsArchive trial documentation and correspondence.Assemble regulatory applicationsApprove the supply of formulated drug to outside clinicians who wish to conduct human studiesattend Investigator meetings requiring travel and report pertinent information back to research team members.Attend seminars, courses and meetings within and outside the companyBuild and manage the Trial Master File (TMF)Capture pertinent data onto source documents (i.e., vital signs, adverse events, concomitant medications, etc.).Coach and provide guidance to clinical staff.collaborate in research projects at universitiesCollect data as required by the protocol and complete case report forms and reviews for completeness.control different protocol versions and other essential documentsCoordinate with the ethics committeeCoordinate approval of new study agreements and contracts.Create clinical project documents according to the protocolDesign case record formsdevelop the study budgetDistribute study supplies, including study drugsDevelop protocolsEnsure subject safety and adverse event reporting to sponsor and IRB/IEC.Ensure consistency between the protocol and CRFInitiate clinical trials Identify site issues and initiates correction plans based on monitoring reports.Evaluate, review and assess protocols and amendments for feasibility Work with the PI to manage the day-to-day activities of the study including problem solving and protocol management.

Education

  • Manual Therapy in from Katholieke Universiteit Leuven in 1998
  • Physical Therapy in from Universiteit Gent in 1997

Languages

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

Work Preferences

  • Work From Home:
    No
  • Work Regime:
    BrightOwl freelancer :    24 Hours per week
  • International:
    Yes

Area / Region

Gent

Others

Driving License
  • Yes

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