Covance

  • Xcellerate Technical Deployment Lead

    Job Location(s) US-NC-Raleigh-Durham | US-NJ-Princeton | PL-Warsaw | CA-ON | AU-Sydney
    Job Number
    2018-26017
    Job Category
    Information Technology
    Position Type
    Full-Time
  • Job Overview

    The Senior Analyst is an experienced member of the Xcellerate Monitoring Integration and Configuration Services (XMICS) team supporting global risk based monitoring team and has responsibility for execution of several key Risk Based Monitoring (RBM) data integration, standard and custom mapping and tool configuration and customization activities and operates as a Lead XMICS Analyst for a series of studies. The Senior Analyst collaborates with the study team to define configuration plans, map operational and clinical data, set up central monitoring tools and dashboards to comply with the central monitoring configuration plans. The Senior Analyst requires working knowledge of three or more areas of programming (e.g. clinical data structures and mapping, tool configuration and JSON, JavaScript or HTML5 programming) as well as a working knowledge of broader drug development and clinical trials. He/she is responsible for accurate and timely uploading of operational and clinical trial data and refresh of central monitoring dashboards and tools. He/she provides RBM tool expertise to the study team. He/she will lead Xcellerate Monitoring, RBM and central monitoring integration and configuration services for a series of clinical studies.

     

    Essential Job Duties:

                                                                    

    • Lead XMICS Analyst for a series of studies
    • Support Request For Proposal (RFP) opportunities
    • Performs accurate tracking and status reporting of RBM studies in his/her remit.
    • Review New Award Notification
    • Collect New Award study details
    • Update Clinical Business Informatics and Solutions & MDFO Project Trackers
    • Review Standard Libraries for multipled Xcellerate Tools
    • Assess study specific requirements
    • Develop XRIM Configuration Plans for Xcellerate Monitoring tools including Xcellerate Risk Review (XRR), Medical Review (XMR), Statistical Review (XSR), Data Review (XDR) and Risk & Issue Management (XRIM)
    • Develop and Verify export requirements
    • Obtain Standard Data Sources and develop contacts with providers
    • Obtain non-Standard Data Sources and develop contacts with providers
    • Perform, Document & verify standard and Custom study Mapping to Operational Data Warehouse (ODW)
    • Verify ODW study mapping
    • Perform, Document & verify Standard and Custom study mapping to Study Data Warehouse (SDW)
    • Verify study mapping to SDW
    • Perform, document & verify standard XRR, XMR, XSR and XDR study configuration
    • Develop export programs in at least two of Xcellerate® Monitoring tools
    • Perform XRR, XMR, XSR, XDR and XRIM study testing & support launch in production
    • Develop & verify study specific data sources, risk indicators & visualizations
    • Perform regular data loading into SDW
    • Support resolution of helpdesk calls
    • Perform, document and verify maintenance and update of standard in Xcellerate Monitoring tools
    • Produce and verify eTMF artefacts during studies from Xcellerate Monitoring tools
    • Ensure resolution of SDW data loading exceptions, errors and performance issues
    • Perform, document and verify client specific export
    • Produce and verify final eTMF artefacts during study closure from Xcellerate Monitoring tools
    • Perform dataset extraction for long term storage

    Education/Qualifications

    Required:

    University degree education required (preferred in computational, physical or life science with a strong quantitative focus).

    Experience

    Minimum Required:

    Minimum of four years clinical trials electronic data collection (EDC) design, clinical data management, biostatistical programming OR minimum of three years hands-on experience in analysis, modeling and visualization of large complex and heterogeneous datasets.

    Strong understanding of algorithms and their scalability

    Strong programming skills in 3 of the following; SAS, C#, C++, R, Matlab or equivalent

    Strong understanding of relational databases and SQL

     

    Preferred:

    Some experience with NoSQL databases and other big data technologies.

    Two years’ experience with web development e.g. JavaScript, JSON, Oracle InForm, Medidata Rave or HTLM5.

    Experience of risk management, risk based monitoring or central monitoring.

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