Regulatory Scientific and Health Solutions
Clinical Data Coder - Data Management Specialist
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Location: Home based Duration: 6-Week contract with extensions dependent on project work Hours: Part time Rate: Competitive hourly rate outside IR35, dependent on experience
Overview We are seeking a Clinical Data Coder who will be responsible for medical terminology coding and data review using Medidata Rave and Medidata Coder. The clinical data coder will ensure accurate, consistent coding of adverse events, medical history, and concomitant medications using industry-standard dictionaries (MedDRA, WHO Drug), supporting high-quality datasets for analysis. The ideal candidate combines technical proficiency in data coding with an understanding of data integrity, compliance, and operational efficiency.
Key Responsibilities
- Perform medical coding of adverse events, medical history, and concomitant medications using Medidata Coder with MedDRA and WHO Drug (or equivalent), following sponsor and CRO coding conventions and SOPs.
- Review verbatim terms for completeness and clarity, raise and resolve coding-related queries with sites, data managers, and medical monitors, and document decisions for audit-readiness.
- Support study start-up activities for coding: dictionary/version selection, configuration of Medidata Coder, creation or maintenance of study-specific glossaries and un-coded term rules.
- Collaborate closely with Data Management, Biostatistics, and Clinical Operations to align coding practices with overall data quality and trial objectives.
- Support in training of project members to support data coding activities.
- Process automation: Build automated workflows (e.g., scheduled jobs, scripts) to reduce manual intervention in data handling and validation processes.
- Data quality and validation: Implement rule-based validation checks, data audits, and reconciliation processes to ensure data accuracy, completeness, and traceability.
- Data governance support: Maintain documentation, data dictionaries, and audit trails to support data integrity and compliance with internal and regulatory standards.
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Required Skills & Qualifications
- Experience working in a CRO environment, delivering coding activities across multiple clinical trials and sponsors.
- Practical experience with Medidata Rave and Medidata Coder
- Strong understanding of MedDRA for events/medical history and WHO Drug (or similar) for medication coding, including hierarchy/navigation and versioning.
- Good knowledge of clinical data management processes within a CRO (study setup, data cleaning, SAE reconciliation, database lock) and how coding fits into the broader workflow.
- Ability to interpret medical terminology, free-text verbatim entries, and protocol context to select appropriate codes and determine when to seek medical review.
- Strong written and verbal communication skills to work effectively with internal teams and sponsor contacts, including clear documentation of coding decisions.
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