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Experiences

Current Experience

  • Senior Project Manager


    Since April 2016

Past Experience

  • Project Manager

    May 2015 --- March 2016

  • Clinical Project Manager (CPM)

    November 2014 --- May 2015

  • Study Delivery Manager Rixensart

    January 2011 --- October 2014
    Project Management

  • Clinical Research Associate (CRA)

    September 2008 --- January 2011
    Phase II

  • Clinical Study Nurse (SN)

    January 2008 --- September 2008
    Phase II

  • Clinical Research Associate (CRA)

    May 2006 --- January 2008
    Phase II

  • Scientist and commercial consultant

    January 2004 --- December 2004
    University

  • researcher

    September 1999 --- December 2004
    Cancer

Personality

BrightOwl Assessment :
OrganizationDiligenceCuriosityPerspectiveDependability
Self Assessment :
AdaptabilityAttention to detailTrustSociabilityIndependenceEfficiency

Knowledge

BrightOwl Assessment :
FrenchdutchEnglishLife SciencesTeamworkClinical trial designPhases of clinical development (phase I to IV)Scientific methodologyClinical monitoringGood Clinical Practice (GCP)
Self Assessment :
Medical oncology Allergy and immunologyGastroenterologyHematologyOrthopedic surgeryGeneral surgeryDrug development processData entryClinical trial designICH GCP guidelinesDesigning case report formsPhases of clinical development (phase I to IV)Randomization and blindingPrinciples and ethics of clinical researchInformed Consent ProcessEthics submission and approval process
LinkedIn Assessment :
oncologyGCPLife SciencesPharmaceuticalsSOPCancerClinical researchClinical trialsClinical trial managementClinical monitoringCROClinicalClinical DevelopmentCTMSPharmaceutical IndustryProtocolICH-GCPSOPLifesciences

Skills and Expertise

BrightOwl Assessment :
Act as the main line of communication between the sponsor and the investigatorAnswer, transfer and handle incoming calls as needed. Build and manage the Trial Master File (TMF)Calculate timelines for conducting and completing the trialCoach and provide guidance to clinical staff.Design the studyLiaise with doctors and other professionals throughout the studyParticipate in meetings with sponsors, monitors and regulatory authorities, as necessary.Plan work to meet objectives and deadlines
Self Assessment :
Act as the main line of communication between the sponsor and the investigatorAdminister, maintain and co-ordinate the logistical aspects of clinical trialsassess operational feasibility and recommend study execution planAssess subject safety during trialattend Investigator meetings requiring travel and report pertinent information back to research team members.Build and manage the Trial Master File (TMF)Calculate timelines for conducting and completing the trialCoach and provide guidance to clinical staff.Collaborate with PI and institution to respond to any audit findings and implement-approved recommendations.Contact potential patients and schedule trial visitsDesign a tracking systemDesign the studyDesign case record formsDetermine availability of facilities and equipment at the siteWork with coordination and data management teamsEnsure consistency between the protocol and CRFInitiate clinical trials

Education

  • DEA in Biological Engineering from in 2001
  • in pharmacy from Université du Québec à Montréal in 1999
  • D.E.S in Applied biology from in 1999
  • in Biology from in 1998

Training and Certification

  • Full week of Dutch Course in 2014 Training
  • Working and communicating with Japanese colleagues or clients in 2013 Training
  • Managing the others in 2012 Training
  • Communication skills in 2006 Training
  • GCP in 2014 Certification
  • Project Management Essentials course in 2011 Certification
  • Clinical Research Training for Senior CRA in 2008 Certification

Work Preferences

  • Work From Home:
    No
  • Work Regime:
    Permanent position
    BrightOwl employee
  • International:
    Yes

Area / Region

Nivelles

Others

Driving License
  • No

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