OVERVIEW
The Medical Coder is responsible for centralized medical coding activities and serious adverse event (SAE) reconciliation, serving as the lead coding resource for assigned clinical trials. This role ensures the accuracy and compliance of coding practices, maintains Medical Coding Guidelines and SAE Plans, and supports the reconciliation of serious adverse events.
KEY TASKS & RESPONSIBILITIES
➢ Design and maintain Medical Coding Guidelines and Serious Adverse Event reconciliation plans in collaboration with sponsors
➢ Perform precise and consistent medical coding following coding guidelines and utilizing MedDRA and WHODrug dictionaries
➢ Conduct reviews for coding accuracy and consistency reviews including the approval of coded terms and synonym lists
➢ Perform serious adverse event reconciliation across clinical trial databases, safety systems and other relevant sources
➢ Generate coding/SAE queries as necessary
➢ Collaborate with safety, clinical, and data management teams to resolve discrepancies and ensure accurate representation of medical coding and safety information
➢ Document coding decisions and justifications for clarity and auditability
➢Assist in maintenance activities for coding tools, including User Acceptance Testing (UAT) script creation and execution
➢ Participate in the completion of MedDRA and WHODrug dictionary up versioning workflow activities in alignment with medical coding guidelines
➢ Perform testing of coding tool and deployment of coding/SAE listings in elluminate®
➢ Ensure compliance with eClinical Solutions and industry quality standards, regulations, guidelines, and procedures
➢ Other duties as assigned
Education & Experience
➢ Bachelor’s degree in relevant health science or professional qualification in a relevant scientific/technical discipline preferred
➢ 5+ years’ experience in the Pharmaceutical/Biotechnology industry with medical coding experience using WHODrug and MedDRA preferred
➢ Knowledge of industry standards, ICH guidelines, and regulatory requirements for medical coding
Professional Skills
➢ Strong knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology
➢ Excellent verbal and written communication skills
➢ Detail oriented, ability to multitask with strong prioritization, planning and organization skills
➢ Proven ability to work both independently and in a team setting.
Technical Skills
➢ Proficiency in Microsoft Office Applications
➢ Experience working on EDC systems. Medidata Rave Coder experience desirable