Coding Specialist – Clinical Data Management
Company: [Insert Company Name]
Location: Remote, India
Job Type: Full-Time
Category: Clinical Research / Data Management
Experience Required: 1 – 2 years in medical coding or clinical data management
Job Overview
We are seeking a Coding Specialist to join our global clinical data management (CDM) team. The ideal candidate will be responsible for accurate coding of clinical and medical terminology using standard dictionaries and study-specific Coding Plans. This role ensures high-quality, compliant, and analysis-ready data for clinical trials across multiple therapeutic areas.
The Coding Specialist will partner with CDM project teams, resolve data discrepancies, maintain coding documentation, and generate regular status reports to support inspection-ready datasets.
Key Responsibilities
Medical Coding & Data Management
Perform coding of adverse events, medical history, and other clinical data according to the study Coding Plan and Data Validation Manual (DVM)
Review coding listings and identify discrepancies or data issues
Collaborate with study teams and sites to resolve data queries and ensure coding accuracy
Ensure all coding deliverables are completed on time, within budget, and compliant with SOPs, GCP, and regulatory guidelines
Project Support & Reporting
Produce project-specific status reports for internal management and client review
Provide guidance to CDM project teams on coding practices and documentation standards
Contribute to inspection-ready, high-quality datasets to support clinical and regulatory submissions
Education & Experience
Education:
Bachelor’s degree or equivalent in Life Sciences, Pharmacy, or related field
Experience:
1 – 1.6 years of experience in clinical data management or medical coding
Experience using RAVE/Veeva EDC, WHODD, MEDDRA coding dictionaries
Skills & Competencies
Strong knowledge of medical and clinical terminology
Detail-oriented with strong analytical and problem-solving skills
Excellent written and verbal communication skills in English
Ability to maintain confidentiality of clinical and proprietary data
Flexibility to work independently or as part of a team
Understanding of clinical trial protocols and Data Validation Manuals
Familiarity with regulatory requirements, SOPs, and GCP guidelines
Career Growth & Global Exposure
Opportunity to advance along the Clinical Data Management (CDM) track, including Senior CDM, CDTL, and CDM PM roles
Exposure to international clinical trials, CRO collaborations, and global study teams
Hands-on experience with modern CDM tools, AI-enabled workflows, and data quality processes
Develop expertise in clinical data integrity, coding standards, and inspection-ready datasets
Why Join Us
Global Exposure: Work across therapeutic areas and phases with international teams, CROs, and vendors
End-to-End Ownership: Contribute to study delivery from setup to close-out
Professional Growth: Gain experience with modern CDM systems, coding standards, and global regulatory compliance
Impact: Play a key role in generating high-quality, accurate clinical data that supports drug development
Gujarat :
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