PRAHS

  • Principal Clinical Data Standards Consultant

    Job Locations (All) | US-Remote
    Posted Date 2 weeks ago(1/8/2019 10:54 AM)
    ID
    2019-51351
  • Overview

    • Developing and maintaining Rave libraries that are used across all Janssen TAs or used within a specific Janssen TA. This includes but is not limited to
      • Developing and implementing specifications for a Rave form
      • Working with Architect Loader Spreadsheets (ALS) and uploading ALS to Rave
      • Developing and implementing data validation rules for a Rave form
      • Supporting the implementation of custom functions in Rave form
      • Working with Rave Library Wizard
      • Developing a User Acceptance Testing (UAT) plan and related test scripts for a set of Rave forms
      • Executing UAT and reports accurately findings using reporter module in RAVE
    • The scope includes
      • Global forms (Cross therapeutic area), Questionnaires and rating scales and disease area specific forms (Therapeutic Area specific)
      • Library hierarchy of global forms library and therapeutic area specific preconfigured libraries
      • Metadata of these forms
    • Provide the support to the TA leads at Janssen who are working directly with the clinical team representatives
    • Implement CDISC CDASH and SDTM standards

    Responsibilities

    • Developing and maintaining Rave libraries that are used across all Janssen TAs or used within a specific Janssen TA. This includes but is not limited to
      • Developing and implementing specifications for a Rave form
      • Working with Architect Loader Spreadsheets (ALS) and uploading ALS to Rave
      • Developing and implementing data validation rules for a Rave form
      • Supporting the implementation of custom functions in Rave form
      • Working with Rave Library Wizard
      • Developing a User Acceptance Testing (UAT) plan and related test scripts for a set of Rave forms
      • Executing UAT and reports accurately findings using reporter module in RAVE
    • The scope includes
      • Global forms (Cross therapeutic area), Questionnaires and rating scales and disease area specific forms (Therapeutic Area specific)
      • Library hierarchy of global forms library and therapeutic area specific preconfigured libraries
      • Metadata of these forms
    • Provide the support to the TA leads at Janssen who are working directly with the clinical team representatives
    • Implement CDISC CDASH and SDTM standards

    Qualifications

    Skill sets

    Required

    • Rave eDC experience and expertise
    • CDISC CDASH and SDTM expertise
    • Rave Standards development experience
    • Handle multiple tasks and prioritize accordingly
    • Ability to learn and use ad hoc tools (e.g. running SAS jobs) for expedited production
    • Track record of delivering according to plan
    • Has excellent communication skills, verbal and written
    • Can work autonomously in a cross functional environment

    Other which as re a plus

    • Cross Therapeutic Area experience
    • Global work experience
    • SAS LSAF experience
    • HPALM experience

     

     




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