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Clinical Data Coder I

Parexel
Parexel
2-4 years
Not Disclosed
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.