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Coding Specialist Ii

3-5 years
Not Disclosed
10 Sept. 15, 2025
Job Description
Job Type: Full Time Education: B.Sc/ M.Sc/ M.Pharm/ B.Pharm/ Life Sciences 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

Job Title: Clinical Data Coding Specialist

Location: Office or Home-Based

Travel Requirements:

  • Regional travel: 5%

  • Of which overnight travel: 50%

  • Destinations vary


Job Overview

The Clinical Data Coding Specialist will support data management leadership on large/global projects or multiple projects. The role focuses on Thesaurus Management and provides technical oversight for all dictionary coding activities to ensure accurate medical coded data delivery in line with Fortrea/client quality standards, project timelines, and budgets. The position also involves close collaboration with Project Lead Data Reviewers, core team members, and Clinical Lead Data Managers as required.


Key Responsibilities

  • Independently perform clinical medical data coding for assigned global projects.

  • Collaborate with the Manager to support career development, enhance interpersonal skills, and achieve competency standards.

  • Identify and implement solutions for project data management coding issues.

  • Serve as the project liaison, providing coding status updates.

  • Assist in reviewing Data Management Plans (DMPs) and Study-Specific Dictionary Coding Conventions and Specifications.

  • Collaborate with project and specialty teams (clinical, programming, statistics, clinical data management, drug safety) to ensure consistent, high-quality coded clinical data.

  • Contribute to the development and implementation of global SOPs and Work Instructions, liaising with other disciplines as needed.

  • Maintain coding technical competencies through internal and external training programs.

  • Support project staff in achieving client satisfaction by delivering high-quality, on-time, and on-budget coded data.

  • Identify and implement process and efficiency improvements in assigned projects.

  • Assist with verification of Fortrea standard dictionaries and client dictionaries.

  • Conduct dictionary verification for assigned projects.

  • Research literature and emerging technologies/procedures to enhance global thesaurus management practices.

  • Perform additional duties as assigned.


Minimum Qualifications

  • University/college degree in life sciences, pharmacy, or related field preferred, or certification in an allied health profession (e.g., nursing, medical/laboratory technology).

  • Equivalent relevant experience may be considered in lieu of formal education.

  • Fluent in English (written and verbal).


Experience Requirements

  • Minimum 3–4 years of relevant work experience in clinical data management, including at least 2 years in clinical data coding (MedDRA and WHODrug).

  • Strong knowledge of medical coding processes and tools (e.g., Medidata Coder, Central Coding).

  • Demonstrated interpersonal and communication skills (oral, written, and presentation).

  • Familiarity with clinical trial processes, data management, clinical operations, biometrics, quality management, and relevant systems applications.

  • Understanding of CRO-pharma/biotech relationships and regulatory obligations.

  • Broad knowledge of thesaurus management processes and Standard Coding Dictionaries.

  • Knowledge of ICH Guidelines, GCP, and international regulatory requirements related to clinical data coding.

  • Understanding of effective clinical data management practices.


Preferred Qualifications

  • MedDRA Certification.

  • Familiarity with Fortrea’s organizational structure, SOPs, and Work Instructions.


Physical Demands / Work Environment

  • Office or home-based work environment.

  • Regional travel required (as detailed above).