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Experiences

Current Experience

  • Global Data Manager Consultant


    Since July 2013
    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 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
    1. study set-up • review and understand Clinical Trial Documentation and, if appropriate, contribute to the preparation of documents • prepare and review trial level Documentation such as crf completion guidelines, dmp, Validation check specs, uat plans, reports and conventions necessary to ensure high quality and consistent data. • set up and maintain accurate trial Documentation and filing systems to ensure safe and secure storage of data and Documentation • provide input into eCRF/crfs, Clinical Trial Database design and Validation check programming • perform uat of assigned Clinical Trial Databases. • create listing specifications to be programmed or create basic reports using available Software. review data listings as part of the data review process • provide site/sponsor staff study specific Training for edc trials and provide on-going support to site 2. study management • take a lead role and act as the main sponsor contact • ensure ongoing data processing and highlight any issues that may affect data quality • identify errors or inconsistencies and resolve them or initiate their resolution. • ensure the implementation of the guidelines across the trial and that they are consistently adhered to • ensure all relevant individuals are regularly updated on project status • proactive Planning and Forecasting of workload requirements • load any required electronic data into the trial database at designated time points throughout the trial, and liaise with the data vendor and/or Investigator site to resolve any resulting errors • maintain an accurate status of all aspects of the trial and be proactive tin ensuring smooth and successful timely locking of Databases • ensure tasks documented in the study contract are completed on time and have an understanding of the trial budget • identify and manage changes in scope • respond to requests made by the sponsor for information or Presentations • prepare for and participate in internal and external audits

  • 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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