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Experiences

Past Experience

  • Senior Data Manager

    January 2009 --- March 2013
    • in charge of all aspects of the data management process from the definition and design of crf and database to the release of a clean database for Statistical Analysis. • mainly in charge of complex projects requiring a long-term experience and high level competencies in Clinical Data Management. • Communication with the sponsor and other interlocutors of the project regarding data management issues. • may be appointed project Coordinator on projects where several iddi departments are involved. • Training and Coaching of clinical data specialist, Data entry personnel, and (new) data managers.

  • Clinical data manager

    January 2003 --- January 2009
    • in charge of all aspects of the Data Management process from the definition and design of crf and database to the release of a clean database for Statistical Analysis. • Communication with the sponsor and other interlocutors of the project regarding Data Management issues. • Training and Coaching of Clinical data specialist and Data entry personnel.

  • Data Entry Operator

    January 2000 --- January 2003
    • responsible for receipt, tracking, Data entry and filing of crfs and other documents containing Clinical data. • participation to Quality Control activities (e.g. for a database audit) • participation to the creation/maintenance of the dm Documentation. • archiving

Personality

Self Assessment :
Attention to detailCollaborationEfficiencyFlexibilityIndependenceOrganizationProblem solvingSelf-confidenceReaction to stressCommunicative

Knowledge

Self Assessment :
Phase I21 CFR Part 11Adverse Events (AE)Biomedical SciencesBudgetsCancer ResearchClinical Data Management (CDM)
LinkedIn Assessment :
CRF designClinical Data ManagementData ManagementSoftware DocumentationData entryTrainingEDCCDISCOracle ClinicalClinical trialsComputer System ValidationCROGCPICH-GCPCTMSSASoncologyValidationClinical researchBiostatisticsClinical Development

Skills and Expertise

Self Assessment :
Act as the main line of communication between the sponsor and the investigatorArchive trial documentation and correspondence.assess the needs of the project(s)/program(s) and make changes in process, work flow and/or assignments.Assist with site trainingAttend seminars, courses and meetings within and outside the companyBuild trial master file (TMF)Calculate timelines for conducting and completing the trialCoach and provide guidance to clinical staff.Communicate effectively on different company levelsConduct the trialCoordinate projectsCreate clinical project documents according to the protocolData codingData entryDesign case record form (CRF)Design clinical trialDesign data collection systemsDesign database Design information leafletDevelop strong internal relationships with stakeholdersLead teamsLiaise with research team in order to accurately collect and record dataLiaise with research teamManage complexityManage data collection systemManage multiple projectsPlanning clinical studiesPrepare internal audits

Education

  • Lic. Medical biology in Biomedical Sciences from Université Libre de Bruxelles (ULB) in 2002

Training and Certification

  • Data Management Practices in Cancer Trials (Part 1 & 2) SCDM, Belgium in 2010 Training
  • Communication Seminar ADMC, Belgium in 2010 Certification

Languages

BrightOwl Assessment:
Self Assessment:
French
Native
English
Professional Proficiency

Work Preferences

  • Work From Home:
    No
  • Work Regime:
    Permanent position :    100% FTE
    BrightOwl freelancer
    BrightOwl employee :    100% FTE
  • International:
    Yes

Area / Region

Namur, Belgium

Others

Driving License
  • Yes

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