Medical Coder

Medical Coder Overview

• The Medical Coder will oversee centralized medical coding activities and serious adverse event (SAE) reconciliation for clinical trials.
• Ensure compliance with industry standards and guidelines while maintaining Medical Coding Guidelines and SAE Plans.
• Collaborate with sponsors, safety, clinical, and data management teams to ensure accurate coding practices.
• Perform precise medical coding using MedDRA and WHODrug dictionaries, ensuring accuracy and consistency.
• Support the reconciliation of serious adverse events across various clinical trial databases and safety systems.
• Document coding decisions and justifications to maintain clarity and auditability.
• Participate in coding tool maintenance and dictionary versioning workflows.
• Contribute to the deployment and testing of coding tools and listings in elluminate®.

Medical Coder Key Responsibilities & Duties

• Design and maintain Medical Coding Guidelines and SAE reconciliation plans in collaboration with sponsors.
• Perform accurate medical coding using standardized dictionaries such as MedDRA and WHODrug.
• Conduct reviews for coding accuracy, consistency, and approval of coded terms and synonym lists.
• Reconcile serious adverse events across clinical trial databases and safety systems.
• Generate and resolve coding/SAE queries as necessary to ensure data integrity.
• Collaborate with cross-functional teams to address discrepancies and ensure accurate data representation.
• Document coding decisions and justifications for audit readiness and clarity.
• Support coding tool maintenance, including User Acceptance Testing (UAT) and script creation.
• Participate in dictionary up-versioning workflows and ensure compliance with guidelines.

Medical Coder Job Requirements

• Bachelor’s degree in health science or a relevant scientific/technical discipline preferred.
• 5+ years of experience in the Pharmaceutical/Biotechnology industry with medical coding expertise.
• Proficiency in using MedDRA and WHODrug dictionaries for medical coding.
• Strong knowledge of ICH/GCP guidelines, 21 CFR Part 11, and clinical trial methodology.
• Experience with EDC systems, with Medidata Rave Coder experience being desirable.
• Proficiency in Microsoft Office Applications and excellent communication skills.
• Detail-oriented with strong prioritization, planning, and organizational skills.
• Ability to work independently and collaboratively in a team setting.