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Experiences

Current Experience

  • Global Data Manager Consultant


    Since July 2013
    Clinical Data Management PRINCIPAL RESPONSIBILITIES: • Liaises continually between the CRO, the trial customer(s) and other internal and external partners to establish, align and confirm data management expectations for assigned trial(s) • With the trial customer, CRO and other functional partners: o Gathers content and integration requirements for eCRF and other data collection tools o Establishes conventions and quality expectations for clinical data o Establishes expectations for dataset content and structure o Sets timeline and follow-up regularly to ensure delivery of all Data Management milestones • Performs trial level oversight controls as described in the oversight plan, QC process and work instructions • Prepares or reviews clinical data management documents (including submission package) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format and consistency; ensures compliance with regulatory guidelines and the documentation matrix • Ensures real-time inspection readiness of all IDS deliverables for the trial; Participates in Regulatory Agency and J&J internal audits as necessary • Plans and tracks content, format, quality, and timing of data management deliverables, including, but not limited to, CRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival; ensures deliverables are on time and within budget • Supports the assigned clinical working group(s) to ensure that IDS and TA trial needs and deliverables are met • Provides input to the DML on trial initiation needs (scope of work, budget, resources), and CRO selection in non-standard situations as appropriate • Identifies and communicates lessons learned, best practices and frequently asked questions at trial level • Identifies and participates in process, system, and tool improvement initiatives within IDS • Presents and trains at investigator and monitor meetings

Past Experience

  • Clinical Data Manager (DM)

    October 2008 --- July 2013
    Clinical Trial

  • Graphician using Photoshop

    July 2008 --- October 2008

Knowledge

LinkedIn Assessment :
Microsoft OfficeMicrosoft ExcelMicrosoft WordPowerPointEnglishResearchWindowsOutlookPhotoshopCROElectronic Data Capture (EDC) Clinical trialsCRF designValidationData ManagementClinical researchCDISCICH-GCPClinical Data Management (CDM)Oracle ClinicalGCP21 CFR Part 11InformSOPProtocolTherapeutic AreasoncologySDTMDrug DevelopmentPharmaceutical IndustryData validationMedidataClinical Study DesignClinical Development

Education

  • Master's degree in Statistics in Clinical Trials and medicine from Polytechnic University of Timisoara in 2012
  • Bachelor's degree in Chemistry & Biology from West University of Timişoara, Faculty of Chemistry, Biology and Geography, in 2008

Area / Region

Belgium

Others

Driving License
  • No

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