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    Clinical Data Coder I

    Parexel
    2-4 years
    Not Disclosed
    Bangalore
    10 Aug. 22, 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

    About This Role: Clinical Data Coder I

    Position Overview:

    The Clinical Data Coder I (CDC I) is responsible for executing clinical data coding tasks with 2 to 4 years of relevant experience. This role involves coding clinical data, generating and integrating queries, and running reports under the supervision of senior coding staff or a line manager. All activities are performed in accordance with corporate quality standards, SOPs, ICH-GCP, and other international regulatory requirements.

    Key Responsibilities:

    1. Clinical Coding:

      • Perform clinical coding mapping using coding dictionaries, mapping to the nearest Low Level Term (LLT) or Drug Name as appropriate.
      • Identify ambiguous verbatim terms and issue queries according to applicable coding conventions.
      • Provide regular updates on work status to the direct supervisor or primary coder and sponsor.
      • Serve as a backup coder in the absence of the primary coder.
      • Contribute to process improvement initiatives.
      • Identify and report issues related to coding and EDC system synchronization.

    2. Coding Setup, Reports, and Documentation:

      • Assist in the setup of coding tools for assigned trials.
      • Author or review coding documents, including conventions, definitions, and configuration specifications.
      • Assist in executing User Acceptance Testing (UAT).
      • Support technical peer review and functional quality control (QC) activities of coding setups.
      • Ensure coding-related documents are appropriately stored in the eTMF systems.
      • Generate Unique Terms Report (UTR).

    3. Dictionary Management and Database Lock:

      • Report discrepancies observed with the clinical dictionary used.
      • Address issues related to the Database Lock (DBL) process and associated documentation.

    4. Project Management & Compliance:

      • Ensure all scheduled timelines are met for assigned studies.
      • Proactively report any coding issues to line managers, reviewers, and study teams.
      • Comply with applicable SOPs, manuals, training, and best practices.
      • Adhere to regulatory requirements (e.g., ICH-GCP).

    Skills:

    • Collaborative team player with the ability to work effectively in a team environment.
    • Quick learner with a knowledge-sharing approach; adept at understanding new technologies and processes.
    • Detail-oriented with a commitment to First Time Quality, including a methodical and accurate approach to work.
    • Strong interpersonal, verbal, and written communication skills.
    • Analytical and problem-solving abilities, including the capability to conduct root cause analyses.
    • Fluent in English, both written and oral.

    Knowledge and Experience:

    • In-depth knowledge of medical terminology and coding dictionaries (e.g., MedDRA & WHODrug).
    • Familiarity with Clinical Trial/Data Management Systems (e.g., InForm, Rave, Veeva, DataLabs) and Microsoft Office products.
    • Understanding of data management processes and data flows.
    • Demonstrated experience in clinical coding.
    • Knowledge of regulatory requirements (e.g., ICH-GCP).
    • Basic understanding of QC and the setup, conduct, and close-out of coding systems and tools.

    Education:

    • Bachelor’s degree or equivalent medical qualification or relevant experience in coding or data management.

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