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Summary

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Experiences

Current Experience

  • Global Lead CRA

    Home based
    Since August 2007

    Communication CRA team (internal & CRO), participate in selection vendors, Training/Coaching junior CRA's, development of Training tools + Presentations (international Investigator meeting/regular team meetings (webinar)), audit fu (capa), representative of monitoring team in project team.

    development of study documents: science)" rel="nofollow">Protocol review, review of crf, icf, crf guidelines

    development of recruitment Planning & monitoring guidelines

    global trials

     

    Communication CRA team (internal & CRO), participate in selection vendors, training/coaching junior CRA's, development of training tools + presentations (international investigator meeting/Regular team meetings (webinar)), audit FU (CAPA), representative of monitoring team in project team.

    Development of study documents: Protocol review, review of CRF, ICF, CRF guidelines

    Development of recruitment planning & monitoring guidelines

    Global trials

     

Past Experience

  • Clinical Project Manager (CPM) Home based

    June 2011 --- April 2014

    Project Planning: lead kick off meeting(s), Communication CRA team (internal & CRO), lead medical team meetings, selection & negotiations vendors, vendor management, Training/Coaching junior CRA's (& Sales reps), development of Training tools + Presentations (international Investigator meeting/regular team meetings (webinar)), audit fu (capa)

    development of study documents: science)" rel="nofollow">Protocol writing/review, development/review of crf, icf, monitoring guidelines, crf guidelines, Quality Management plan

    Negotiation & review of trial budget and management.

    co-monitoring visits CRA - quality & accompanied visits - part of quality plan

    european trial

     

  • Clinical Project Manager (CPM) Oostakker, Gent, België

    February 2007 --- June 2012

    local Phase IV trials - writing of protocols/development of icf, crf, Training tools/coordination of Sales reps/CRA's, monitoring

    Phase III trial - unblinded monitoring

  • Clinical Project Manager (CPM) Brussels, Belgium

    December 2009 --- October 2010

    local Project Management - Phase IV trials:

    management local CRA team, science)" rel="nofollow">Protocol writing, icf/crf/monitoring guideline development, ca/ec submissions, development prestudy and initiation visit tools.

  • Clinical Project Manager (CPM) Niel

    June 2008 --- May 2009

    Project Management/Business DevelopmenteCRF - international (europe – asia – us)

    client contact, eCRF development, project/team management, planning/Documentation development/follow-up audit – Sales support, Training during Investigator meeting    

Personality

Self Assessment :
Problem solvingAttention to detailCreative thinkingCollaboration

Knowledge

Self Assessment :
oncologyOphthalmologyPhase IIPhase IIIPhase IVPulmonary diseasesSupervising CRAsUrologyCardiovascular diseasesClinical researchClinical trial budgetingClinical trial managementContract negotiationCross-functional team leadershipCTMSDesigning case report formsDrug regulatory authoritiesEfficacy trialsElectronic Data Capture (EDC) Ethics submission and approval processFDAICH-GCPInformed Consent ProcessNeurological surgery

Skills and Expertise

Self Assessment :
Design case record forms Monitor a clinical studyAssess site feasibilityCalculate trial timelinesCoach clinical staffCollaborate with project teamCommunicate with investigatorcoordinating research projectsCreate clinical documentsDesign subject consent formEthics committee submissionsInteract with CROsInteract with ethics committeeManage projects resourcesSupervise clinical monitorsSelect investigatorsReview vendor reportsReview study protocolsReview monitoring reportsRespond to audit findingsRegulatory submissionsProvide trainingPresent data at congressOrganise meetingsManage vendor budgetsManage study budget

Work Preferences

  • Work From Home:
    Yes, 4 Days
  • Work Regime:
    BrightOwl freelancer :    max 16h/w Hours per week
  • International:
    Yes

Area / Region

Gentbrugge, Gent, België

Others

Driving License
  • Yes

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