Coding Specialist II
Company: Fortrea
Job Title: Coding Specialist II
Location: Bangalore, India (Remote)
Employment Type: Full-Time
Job Requisition ID: 262800
Application Deadline: June 30, 2026
About Fortrea
Fortrea is a leading global contract research organization (CRO) providing clinical development, patient access, and technology solutions to pharmaceutical, biotechnology, and medical device companies worldwide. The company supports the development of innovative therapies through expertise in clinical trials, data management, regulatory support, and scientific services.
Position Summary
Fortrea is seeking an experienced Coding Specialist II to support global clinical data coding activities and thesaurus management across large-scale clinical research projects. The role is responsible for ensuring accurate and timely coding of medical data using industry-standard dictionaries such as MedDRA and WHODrug, while maintaining compliance with regulatory requirements, quality standards, project timelines, and client expectations.
The successful candidate will collaborate with Clinical Data Management, Clinical Operations, Biostatistics, Drug Safety, and other cross-functional teams to ensure high-quality coded clinical trial data throughout the study lifecycle.
Key Responsibilities
Medical Coding & Thesaurus Management
Independently perform medical coding activities for assigned global clinical studies.
Manage and maintain coding activities using standard industry dictionaries such as MedDRA and WHODrug.
Ensure coded clinical data meets project-specific quality, consistency, and regulatory requirements.
Provide technical oversight for dictionary coding activities across assigned projects.
Project Coordination & Stakeholder Communication
Serve as a coding representative and project liaison for coding-related activities.
Provide project-specific coding status updates to stakeholders and project teams.
Collaborate closely with Lead Data Reviewers, Clinical Data Managers, and core project teams.
Support study start-up, conduct, maintenance, and closure activities related to medical coding.
Coding Standards & Documentation
Assist in reviewing and maintaining:
Data Management Plans (DMPs)
Study-Specific Coding Conventions
Coding Specifications and Guidelines
Ensure coding practices align with project requirements and industry standards.
Quality & Compliance
Conduct dictionary verification for both Fortrea standard dictionaries and client-specific dictionaries.
Perform coding quality reviews and verification activities.
Ensure compliance with:
ICH Guidelines
Good Clinical Practice (GCP)
International regulatory requirements
Internal SOPs and work instructions
Cross-Functional Collaboration
Work with teams including:
Clinical Data Management
Clinical Operations
Biostatistics
Statistical Programming
Drug Safety / Pharmacovigilance
Quality Management
Support consistent and accurate handling of coded clinical trial data.
Process Improvement & Training
Identify opportunities to improve coding processes, quality, and operational efficiency.
Participate in internal and external training programs to maintain technical expertise.
Support development and implementation of SOPs and work instructions.
Research emerging technologies and best practices related to medical coding and thesaurus management.
Educational Qualification
Required
Bachelor's degree in:
Life Sciences
Pharmacy (B.Pharm)
Biotechnology
Biological Sciences
Related Healthcare Discipline
OR
Certification in an allied health profession such as:
Nursing
Medical Technology
Laboratory Technology
Equivalent relevant experience may be considered in lieu of formal qualifications.
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