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Clinical Coding Specialist

3+ years
Not Disclosed
10 April 18, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

 


Clinical Coding Specialist
Job ID: REQ-10038989
Date: Apr 02, 2025
Location: India

Summary:
Provide timely and professional ongoing management of clinical trial data by performing accurate and consistent coding, providing inputs to the relevant coding sections of the Data Management Documents, and reviewing coding glossaries. Ensures that Coding is current, accurate, dictionary versions and documents are up to date, and database deliverables/timelines are met from a Coding perspective with utmost quality & consistency of data Coding.

About the Role:
Major Accountabilities:

  • Acts as a Lead Coder for multiple trials/Programs. Performs accurate and consistent coding by applying standard conventions, creating appropriate synonyms, and creating/managing coding-related queries as needed.

  • Maintains the Coding-related section(s) of Data Management Documents and ensures that dictionary versions are up to date.

  • Ensures that coding is completed & reviewed in support of study timelines/deliverables, able to manage conflicting timelines/deliverables, and supports other members with their assignments.

  • Independently leads the study from start-up to Database Lock activities from a Coding perspective.

  • Reviews and provides feedback on coding performed by self or others to ensure consistency and quality.

  • Troubleshoots coding problems, collaborating with peers, database developers, and/or IT support as needed.

  • Consults and liaises with relevant stakeholders to resolve Coding queries and issues.

  • Ensures that dictionary upgrades are completed in a timely manner across the remit of trials without impacting the trial timelines/deliverables, contributes in synonym reconciliation.

  • May suggest or contribute to non-clinical initiatives related to dictionary maintenance and update, process improvement initiatives, system update and change management, quality, and productivity improvement, etc.

Key Performance Indicators:

  • Contribute to the achievement of overall goals as set each year by Function.

  • Ability to accurately provide quality coded data.

  • Ability to effectively communicate with the Supervisor/TDM about coding-related processes and issues to support efficient issue resolution.

Minimum Requirements:
Work Experience:

  • 3 or more years of experience in drug development with at least 2 years performing Clinical coding.

  • Strong understanding of medical terminology, including medical conditions and medications.

  • Strong attention to detail.

  • Good communication, problem-solving, negotiation, and conflict resolution skills.

  • Ability to work independently, under pressure, and in an environment where flexibility is required.

  • Understanding of clinical trials methodology, GCP, and coding tools.

Languages:

  • English.

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