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Job highlights

Work/Life Balance

Time management

Flexibility

Problem Solving

Responsibilities:

Clinical Coding:

  • Perform clinical coding mapping using coding dictionaries and map to the nearest Low Level Term (LLT) or Drug Name as appropriate.
  • Identify ambiguous verbatim and issue queries in line with applicable coding conventions.
  • Provide regular work status updates to direct supervisor or primary coder and sponsor.
  • Act as backup in the absence of the primary coder.
  • Provide inputs for process improvement.
  • Identify and report issues with coding and EDC system synchronization.

Coding Set up, Reports, and Documentation:

  • Assist in coding tool setup for assigned trials.
  • Author or review Coding Documents, including Coding conventions, definitions, and configuration specifications.
  • Assist in execution of User Acceptance Testing.
  • Assist in Technical peer review and functional QC activities of coding setup.
  • Ensure coding-owned documents are placed in eTMF systems as appropriate.
  • Generate Unique Terms Report (UTR).

Dictionary Management and Database Lock:

  • Report any discrepancies observed with clinical dictionaries used.
  • Report any issues with DBL process and related documentation.

Project Management & Compliance:

  • Ensure that all scheduled timelines are met for assigned studies.
  • Proactively bring any coding-related issues to the attention of LMs, Reviewers, and study teams.
  • Comply with applicable SOPs, manuals, trainings, and best practices.
  • Ensure compliance with regulatory requirements (e.g., ICH-GCP).

Skills:

  • Ability to work and collaborate in a team environment.
  • Learning ability and knowledge-sharing approach; quick understanding of technologies and new processes.
  • Demonstrates attention to detail and commitment to First Time Quality, including a methodical and accurate approach to work activities.
  • Good interpersonal, verbal, and written communication skills.
  • Demonstrates analytical and problem-solving skills, including the ability to conduct root cause analyses.
  • Written and oral fluency in English.

Knowledge and Experience:

  • Strong knowledge of medical terminology and coding dictionaries (e.g., MedDRA & WHODrug).
  • Knowledge of 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.
  • Understanding of regulatory requirements (e.g., ICH-GCP).
  • Basic knowledge regarding the QC and Setup, Conduct, and Close-Out of Coding Systems and Tools.

Application Link

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