Coding Specialist – Clinical Data Management (Fully Remote, India)
Job ID: R-01338263
Job Type: Full Time
Category: Clinical Research / Clinical Data Management
Work Mode: Fully Remote
Location: India
Work Schedule: Monday to Friday (Standard Business Hours)
About the Role
We are seeking a detail-oriented Coding Specialist to join a global Clinical Research Services organization supporting high-quality clinical trials across multiple therapeutic areas. This role is critical to ensuring accurate, compliant medical coding of clinical data in accordance with global regulatory standards and study-specific coding plans.
As a Coding Specialist, you will work closely with Clinical Data Management (CDM) teams, study sites, and project stakeholders to deliver inspection-ready, analysis-ready coded data. This position operates within a mature Functional Service Provider (FSP) model supporting a leading, globally recognized biopharmaceutical sponsor.
Key Responsibilities
Perform accurate medical coding using approved coding dictionaries in alignment with the study Coding Plan and Data Validation Manual (DVM).
Code and review medical terminology including adverse events, medical history, and concomitant medications.
Review coding listings, identify discrepancies, and collaborate with study teams and sites to resolve data issues.
Ensure all coding activities comply with global SOPs, GCP, regulatory requirements, and client standards.
Deliver high-quality coding outputs within defined timelines, scope, and budget.
Provide guidance and support on coding-related activities to Clinical Data Management project teams.
Maintain coding documentation and ensure audit and inspection readiness.
Prepare and deliver project-specific coding status reports for supervisors and clients.
Education and Experience Requirements
Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or a related discipline (or equivalent qualification).
Minimum 1 to 1.6 years of hands-on experience in clinical data coding within a CRO or pharmaceutical environment.
Mandatory experience with RAVE and/or Veeva EDC systems.
Practical experience using MedDRA and WHO-DD coding dictionaries.
Prior exposure to global clinical trials is preferred.
Required Skills and Competencies
Strong understanding of clinical and medical terminology with exceptional attention to detail.
Ability to interpret study protocols and Data Validation Manuals accurately.
Good knowledge of clinical data management processes and regulatory expectations.
Strong written and verbal communication skills with proficiency in English.
Excellent organizational, analytical, and problem-solving abilities.
Ability to work independently with minimal supervision while meeting project deadlines.
High level of integrity and confidentiality when handling medical and proprietary data.
Strong interpersonal skills with a customer-focused mindset.
Proven flexibility and adaptability in a fast-paced, global team environment.
Sound judgment and decision-making capability in coding-related scenarios.
Career Growth and Development
This position supports a globally recognized biopharmaceutical sponsor known for its leadership in specialty medicines, vaccines, and scientific innovation. As part of the FSP delivery model, you will collaborate with global data science and clinical operations teams on high-visibility programs.
The organization offers structured career development through:
Continuous learning and role-based training pathways
Mentorship and stretch assignments
Opportunities to grow into roles such as Senior Coding Specialist, Senior CDM, CDTL, CDM Project Manager, or transition into Data Standards or Clinical Programming, based on performance and business needs
Why Join Us
Contribute to life-changing clinical research programs impacting patients worldwide.
Gain exposure to international clinical trials across multiple phases and therapeutic areas.
Build expertise in modern Clinical Data Management, including EDC systems, coding standards, and AI-enabled workflows.
Strengthen analytical, project coordination, and risk management skills.
Work in a collaborative, quality-driven, and globally connected environment.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding USD 44 billion. Our mission is to enable customers to make the world healthier, cleaner, and safer. With more than 90,000 colleagues worldwide, we deliver innovative technologies and pharmaceutical services through industry-leading brands including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, and Patheon.
Thermo Fisher Scientific is an Equal Employment Opportunity Employer.
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