Coding Specialist II
Location: Bangalore, India
Company: Fortrea
Department: Clinical Data Management / Medical Coding
Employment Type: Full-Time (Remote)
Role Summary
The Coding Specialist II is responsible for managing and performing clinical data coding activities for global clinical trials, ensuring accurate coding of medical terms using standard dictionaries such as MedDRA and WHODrug. The role supports global data management projects by providing technical expertise in thesaurus management, coding quality oversight, dictionary verification, and process improvement initiatives.
The position works closely with Clinical Data Managers, Lead Data Reviewers, Biostatistics, Programming, Clinical Operations, Drug Safety, and Sponsors to ensure delivery of high-quality coded clinical data within project timelines and regulatory requirements.
Key Responsibilities
Medical Coding Operations
Perform medical coding activities independently across global clinical studies.
Code clinical trial data using:
MedDRA
WHODrug
Sponsor-specific dictionaries
Ensure accurate and consistent coding of:
Adverse Events (AEs)
Medical History
Concomitant Medications
Indications
Procedures
Maintain coding quality and compliance throughout the study lifecycle.
Thesaurus Management
Support global thesaurus management activities.
Perform dictionary verification for:
Fortrea Standard Dictionaries
Sponsor Dictionaries
Ensure proper implementation and maintenance of coding conventions.
Review coding hierarchies and dictionary updates.
Clinical Data Management Support
Collaborate with:
Clinical Data Managers
Clinical Operations Teams
Biostatistics
Programming Teams
Drug Safety Teams
Support study setup, maintenance, and closure activities.
Assist in review of coding sections within:
Data Management Plans (DMPs)
Coding Specifications
Study-Specific Coding Conventions
Project Coordination
Serve as project liaison for coding-related activities.
Provide coding status updates to project teams and stakeholders.
Support project deliverables within agreed timelines and budgets.
Assist in resolving project coding issues and escalations.
Quality & Compliance
Ensure coding activities comply with:
ICH-GCP Guidelines
Regulatory Requirements
Sponsor Standards
Company SOPs
Maintain inspection and audit readiness.
Ensure data integrity and coding consistency.
Dictionary Verification & Validation
Conduct coding dictionary verification activities.
Validate coding outputs and dictionary implementation.
Support coding tool configuration and validation activities.
Ensure coding accuracy before database lock.
Process Improvement
Identify opportunities for:
Coding Efficiency Improvements
Process Optimization
Quality Enhancements
Participate in development and implementation of:
SOPs
Work Instructions
Best Practices
Support continuous improvement initiatives.
Training & Knowledge Development
Maintain coding expertise through:
Internal Training Programs
External Workshops
Industry Conferences
Share knowledge with project teams and colleagues.
Support coding-related training initiatives.
Research & Innovation
Review industry literature and emerging technologies.
Evaluate new approaches to:
Medical Coding
Thesaurus Management
Data Standardization
Recommend improvements to coding practices and tools.
Required Qualifications
Education
One of the Following:
B.Pharm
M.Pharm
Pharm.D
B.Sc Life Sciences
M.Sc Life Sciences
Biotechnology
Microbiology
Biochemistry
Nursing
Medical Laboratory Technology
Allied Health Sciences
Experience
5–7 years of Clinical Data Coding experience.
Hands-on experience with:
MedDRA Coding
WHODrug Coding
Experience working in:
Clinical Data Management
CROs
Pharmaceutical Industry
Clinical Research Organizations
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Frank Scottile Blvd |Missouri :
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Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
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Ingelheim am Rhein | Mainz |Schleswig Holstein :
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Saarbrucken |Switzerland :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Norway | NOrway |Romania :
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Galway |County Dublin :
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China | Quarry Bay |Liaoning :
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Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Queensland |Melbourne :
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Manila |Croatia :
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Sweden |Taipei :
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Warsaw |