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    Sr Clinical Data Associate

    Thermo Fisher Scientific
    3-7 years
    Not Disclosed
    Remote
    10 May 27, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Description: Data Cleaning Specialist

    Summarized Purpose:

    The Data Cleaning Specialist performs all aspects of the data cleaning process, ensuring compliance with Good Clinical Practice (GCP) and Standard Operating Procedures (SOPs)/Work Process Documents (WPDs). They assess the safety and efficacy of investigational products and/or medical devices with minimal supervision.

    Essential Functions:

    1. Study Setup Support:

      • Assist in setting up study activities, including database design, testing of data entry screens, and creation of Data Validation Manuals (DVM), as necessary.

    2. Data Review and Quality Check:

      • Review data listings to ensure accuracy and consistency of data.

    3. Specialized Process Expertise:

      • Act as the point person and subject matter expert for specialized study-specific processes.

    4. Data Clarifications and Query Resolution:

      • Generate, track, and resolve data clarifications and queries.
      • Make changes to the clinical database as required.

    5. Process Improvement:

      • Contribute to the enhancement of data management processes on a global level.

    6. Reporting:

      • Produce project-specific status reports for management and/or clients regularly.

    7. Training and Supervision:

      • Provide training and work direction to junior staff, as needed.

    Education and Experience:

    • Education: Bachelor's degree or equivalent, along with relevant formal academic/vocational qualifications.
    • Experience: Previous experience equivalent to 3 - 7 years, providing the necessary knowledge, skills, and abilities to perform the job effectively.

    This structured format provides a clear outline of the essential functions, educational requirements, and experience necessary for the Data Cleaning Specialist role.

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