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    Junior Lab Data Specialist

    Pfizer
    0-1 years
    Not Disclosed
    Chennai
    10 Aug. 21, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Description: Lab Data Specialist

    Role Overview

    The Lab Data Specialist is responsible for managing and updating lab identifiers (IDs) and reference ranges in EDC systems, supporting both local and central lab IDs for Pfizer studies. This role involves reviewing lab slips, maintaining database updates, and assisting with lab code assignments for incoming data. The Specialist ensures compliance with SOPs, provides guidance on reference range documentation, and supports data managers in resolving lab data discrepancies. The role also includes running data reports and contributing to process improvements.

    Key Responsibilities

    • Lab Data Management

      • Review lab slips and documents to establish normal reference ranges for protocol-required tests and create new lab IDs in EDC systems.
      • Maintain and update lab IDs and reference ranges in the database.
      • Support both local and central lab IDs for all Pfizer studies.
      • Process textbook reference range requests and updates.
      • Assign lab codes to tests for incoming lab data, whether received on CRFs or via electronic transfer.
      • Ensure compliance with all lab-related SOP documents and guidelines.

    • Guidance and Support

      • Provide guidance to study management on collecting complete and accurate reference range documents from investigator sites.
      • Advise the study team on lab ID assignments, data analysis, and resolution of assignment issues.
      • Assist data managers with reviewing and remediating lab data discrepancies during study conduct and reporting.

    • Data Reporting and Improvement

      • Generate lab data listings and reports using Pfizer's browser tools and applications.
      • Support team members in process improvement and automation initiatives.

    Qualifications

    • Basic Qualifications

      • Bachelor’s degree in a life science discipline with 0-1 year of relevant experience in pharmaceutical, biotech, CRO, or regulatory agency environments, focusing on safety lab data solutions.
      • Understanding of drug development processes and data operations related to clinical trial reporting (e.g., data review, study reports, regulatory submissions).
      • Knowledge of CDISC standards and experience with EDC systems such as Oracle Clinical, Data Labs, Rave, and InForm.
      • Strong communication skills (written and oral), decision-making, influencing, negotiation, and project management abilities.
      • Good understanding of laboratory data collection and test units.
      • Proficiency in Microsoft Office Suite (Outlook, Word, Excel).

    • Preferred Qualifications

      • Experience with relational databases (e.g., Oracle) and data visualization/reporting tools (e.g., Spotfire, J Review).
      • Work experience in hospital or clinical diagnostic laboratories.

    Work Location

    • Flexible

    Pfizer's Commitment

    Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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