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    • Clinical Data Associate - Bloemfontein - IQVIA

    IQVIA
    IQVIA Bloemfontein

    1 month ago

    Default job background
    Description

    Job Summary

    This is a comprehensive data management role that involves various tasks including data review, query generation and resolution. The position requires the ability to perform study start-up, execution, database lock and close-out activities.

    Key Responsibilities

    • Data Management Tasks:
      • Create eCRF completion guidelines
      • Enter test data for eCRF and Data Review Model
      • Test data validation rules
      • Ongoing Data Reconciliation of all data streams
    • Meetings/Teleconferences: Attend study related meetings/teleconferences
    • Study Closeout/Archiving: Perform Study Closeout/Archiving Activities including QC of subject/site Archival CRFs
    • Status/Metric Reports: Create and provide status/metric reports
    • EDC Progress Tracking: Generate reports on EDC and track cleaning progress
    • eCRF Freeze/Lock: Manage Freeze / lock of eCRF
    • File Documentation: File documentation in the virtual Trial Master File (TMF)
    • Lab Normal Ranges: Receives and enters lab normal ranges

    Advanced Level Role

    • Timely Status Updates: Provide timely status updates including issues & risks to DM and DMLs as needed
    • Clinical Data Manager: Act as the Point of contact for Clinical Data Manager, working pro-actively to identify risks and provide mitigations
    • Vendor Communication: May communicate with the vendors to resolve reconciliation issues
    • Study Setup: Provide input to Study set up activities including but not limited to creation of DVRs
    • Data Management Documents: Create and/or provide inputs to Data Management documents (e.g. eCRF completion guidelines, etc.)
    • Document Reviews: Review and provide inputs to Data Management documents (e.g. IRP, DMP, etc.)
    • CDA Assignment: Assign work to allocated CDAs on a trial. Coordinate work of CDAs assigned to a study working closely with the Global Data Manager to understand priorities and timelines
    • TMF Compliance: Assist the Data Management Leader in TMF compliance reviews
    • CDA Training: Train and mentor CDA staff
    • SME Participation: May serve as an SME and participate in SME forums
    • Data Manager Delegate: May act as delegate for Data Manager, as needed

    Education and Experience Guidelines

    • Educational Requirements: Bachelor's degree in a Health or Science discipline with experience in clinical research
    • Data Management Experience: Data Management experience and experience working on a clinical trial mandatory
    • Rave Experience: Rave experience mandatory
    • Teamwork: Experience working in highly diverse teams within clinical research; cross-functional, global, multi-regional
    • Industry Standards: Knowledge of current industry standards (e.g., CDISC, SDTM, CDASH, etc.) for Advanced CDA
    • Technology Platforms: Knowledge of technology platforms and systems to capture and process data
    • Project Management: Project management skills
    • Vendor Management: Vendor management skills
    • Microsoft Office Tools: Proficiency with Microsoft Office tools
    • Experience Levels: CDA BASE level: 1-3 years of experience. CDA ADVANCED level: >3 years of experience.

    IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

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