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:
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- 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.
