Clinical Data Coder I

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:

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.
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).
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.
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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Clinical Data Coder I

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