Parexel | Jobs | Clinical Data Analyst II | BigDataKB.com | 19-02-22

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    Job Location: India

    Accountabilities: Demonstrates full competence when conducting the following tasks

    • Development of database build specifications
    • Development of data validation specifications
    • Test data creation & UAT
    • Performing/ leading functional QC activities and testing
    • Create CRF Completion Guidelines (CCG), SAE reconciliation Guidelines, etc.
    • Data validation and cleaning
    • Conduct medical coding if assigned
    • Conduct SAE & third party data reconciliations
    • Perform early and final database QC activities
    • Database lock activities
    • Maintaining Clinical Study Documents and archiving as appropriate

    • Responsible for completeness, timely delivery and quality of clinical data
    • Learning role of Primary CDA
    • Act as a single point of contact (internal expert) for specific processing task(s) on a project
    • Support site monitoring personnel to retrieve missing data as required
    • Other assigned responsibilities as needed Skills
    • Strong interpersonal, verbal and written communication skills
    • Strong technical skills including but not limited to the knowledge of Clinical Trial/Data Management Systems, PMED, IVRS, MS-Office products
    • Good awareness of all relevant regulations, including ICH-GCP, 21 CFR 11
    • Knowledge of medical terminology and awareness of coding dictionaries (e.g.MedDRA & WHODRUG)
    • Seeks opportunities to develop experience and knowledge in Clinical Trials and Pharmaceutical Industry
    • Ability to plan tasks and complete them within the appropriate timescale and to the required quality
    • Ability to work in team environment.
    • Commitment and performs consistently high quality work Education


    Qualifications

    • Bachelor’s degree and / or other medical qualification or relevant DM experience Language Skills
    • Competent in written and oral English. Excellence in regional languages as needed. Minimum Work Experience
    • Must be able to demonstrate proficiency with several tasks included in data start-up through data-base lock. Previous relevant data management work experience required; clinical and/ or research experience with solid understanding of clinical trials methodology and terminology required

    Apply Here

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