Technical Analyst, Informatics
Covance Inc
Warsaw, Poland
1 d. temu

Job Overview :

The Analyst I is a member of Xcellerate Monitoring Integration and Configuration Services (XMICS), part of Monitoring and Data Flow Optimization Team and global risk based monitoring team and supports execution of several key Risk Based Monitoring (RBM) data integration, standard mapping and tool configuration and customization activities and operates as a supporting XMICS Analyst for assigned studies.

The Analyst I 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 Analyst I requires working knowledge of two 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 may provide RBM tool expertise to the study team. He / she will support Xcellerate Monitoring, RBM and central monitoring integration and configuration services for at least 2 clinical studies.

  • Support Lead XMICS Analysts for at least two studies
  • Tracking of Request For Proposal and Project / Studies
  • 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)
  • Obtain Standard Data Sources
  • Obtain non-Standard Data Sources
  • Support development of export requirements
  • Perform, Document & verify Standard study Mapping to Operational Data Warehouse (ODW)
  • Verify ODW study mapping
  • Perform, Document & verify Standard study mapping to Study Data Warehouse (SDW)
  • Verify study mapping to SDW
  • Perform, document & verify standard XRR, XMR, XSR and XDR study configuration
  • Support development of export programs in at least one of Xcellerate® Monitoring tools
  • Perform XRR, XMR, XSR, XDR and XRIM study testing & support launch
  • Perform testing & support development of study specific data sources, risk indicators & visualizations
  • Perform regular data loading into SDW
  • Support resolution of helpdesk calls
  • Perform maintenance and update of standard in two Xcellerate Monitoring tools
  • Produce eTMF artefacts during study from Xcellerate Monitoring tools
  • Perform exception review and error analysis of SDW data loading
  • Perform client specific export
  • Produce final eTMF artefacts during study closure from Xcellerate Monitoring tools
  • Perform dataset extraction for long term storage
  • Education / Qualifications :

    University degree education preferred (if required or experience level which may be substituted for level of education) in science, mathematics or computer science.

    Experience : Minimum Required :

    Minimum Required :

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

    Good understanding of algorithms and their scalability

    Good programming skills in 2 of the following; SAS, C#, C++, R, Matlab or equivalent

    Knowledge of relational databases and SQL

    Preferred :

    One year experience in SQL, NoSQL, JSON, JavaScript or HTML5 programming and development experience.

    No experience of risk management, risk based monitoring or central monitoring is required.

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