Xcellerate Configuration Associate
Covance
Warsaw, Durham
1 d. temu

Overview

The Associate is a member of the Xcellerate Monitoring Integration and Configuration Services (XMICS) team, supporting execution of key Risk Based Monitoring (RBM) tool standard configuration and customization activities and operates as a supporting XMICS Analyst for assigned studies.

The Associate collaborates with the study team to set up central monitoring tools and dashboards to comply with the central monitoring configuration plans.

The Associate requires working knowledge of one or more areas of programming (e.g. clinical data structures and mapping, tool configuration and JSON, JavaScript or HTML5 programming) as well as an understanding 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.

Essential Job Duties :

  • Support Lead XMICS Analysts for studies
  • Perform standard study configuration and study testing in at least one Xcellerate® Monitoring tool (Xcellerate Risk Review, Xcellerate Medical Review (XMR), Xcellerate Statistical Review (XSR) or Xcellerate Data Review (XDR)) (30%)
  • Perform Xcellerate Risk & Issue Management (XRIM) study testing
  • Support development of export programs at least one of Xcellerate® Monitoring tools
  • Perform testing of study specific data sources, risk indicators & visualizations (10%)
  • Perform regular data loading into Study Data Warehouse (SDW) (20%)
  • Support resolution of helpdesk calls
  • Perform maintenance and update of standards in at least one Xcellerate Monitoring tool (10%)
  • Perform exception review and error analysis of SDW data loading (20%)
  • Produce eTMF artefacts during study from Xcellerate Monitoring tools
  • Produce final eTMF artefacts during study closure from Xcellerate Monitoring tools
  • Perform dataset extraction for long term storage
  • Education / Qualifications

    Recommended :

    University degree education preferred in science, mathematics or computer science.

    Minimum Required :

    Proficiency with relational databases and SQL

    Some understanding of algorithms and their scalability

    Programming skills in 1 of the following; SAS, C#, C++, R, Matlab or equivalent

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

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