Coding Specialist II
Location: Bangalore
Category: Clinical
Job ID: 262800
Role Overview
The Coding Specialist II supports global clinical data management activities with a focus on medical coding and thesaurus management. The role involves ensuring high-quality coded clinical data using standard dictionaries such as MedDRA and WHODrug, while maintaining compliance with project timelines, budgets, and regulatory standards.
This position also provides technical oversight of coding activities across global clinical projects and contributes to process improvement and standardization efforts.
Key Responsibilities
1. Clinical Medical Data Coding
Perform medical coding activities for assigned global clinical projects independently.
Ensure accurate coding of clinical trial data using:
MedDRA
WHODrug
Maintain high-quality standards for coded data in alignment with client and regulatory requirements.
2. Thesaurus & Dictionary Management
Manage and support thesaurus management activities.
Perform dictionary verification for:
Fortrea standard dictionaries
Client-specific dictionaries
Assist in implementation of coding conventions and specifications.
3. Project Support & Coordination
Serve as a liaison for project-specific coding status updates.
Collaborate with:
Lead Data Reviewers
Clinical Data Managers
Core study teams
Support setup, maintenance, and closure of data management activities.
4. Data Management Planning & Documentation
Assist in reviewing:
Data Management Plans (DMPs)
Study-specific coding conventions
Ensure coding sections are correctly defined and implemented.
5. Cross-Functional Collaboration
Work closely with:
Clinical Operations
Programming teams
Statistics teams
Pharmacovigilance / Drug Safety teams
Ensure consistent and high-quality clinical data handling across teams.
6. Quality, Compliance & Standards
Ensure compliance with:
ICH Guidelines
Good Clinical Practice (GCP)
Regulatory requirements for clinical trials
Support development and maintenance of SOPs and Work Instructions.
Contribute to global standardization of coding processes.
7. Process Improvement
Identify opportunities for improving coding processes and efficiency.
Support implementation of process improvements across assigned projects.
Review literature and technologies to enhance thesaurus management practices.
8. Training & Competency Development
Maintain technical expertise through continuous learning.
Participate in internal and external training programs.
Work with managers to support career development and competency growth.
9. Client & Stakeholder Support
Support timely delivery of high-quality coded clinical data.
Contribute to client satisfaction by ensuring accuracy, consistency, and timeliness.
Provide regular updates on coding status and project progress.
Required Qualifications
Education
University/college degree in:
Life Sciences
Pharmacy
Allied health sciences
Or equivalent certification (e.g., nursing, medical technology)
Relevant experience may be considered in lieu of formal education
Experience
5–7 years of experience in clinical data coding
Strong hands-on experience with:
MedDRA coding
WHODrug coding
Experience with coding tools such as:
Medidata Coder
Central Coding systems
Technical Knowledge
Strong understanding of:
Clinical trial processes
Clinical data management
Thesaurus management
Regulatory requirements in CRO/pharma industry
Knowledge of ICH Guidelines and GCP
Understanding of biometrics and quality systems
Skills & Competencies
Strong attention to detail and accuracy
Excellent communication skills (written and verbal)
Strong interpersonal and collaboration skills
Ability to work independently on global projects
Problem-solving and process improvement mindset
Preferred Qualifications
MedDRA certification
Knowledge of organization-specific SOPs and systems
Familiarity with CRO structure and operations
Work Environment
Office-based or remote (home-based) work setup
Occasional travel (~5%), including limited overnight travel
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