Medical Coder, Pr

OVERVIEW

The Principal Medical Coder is responsible for overseeing centralized medical coding / SAE activities and managing a team of Medical Coders. Highly proficient and detail-oriented specializing in accurately coding complex medical data from clinical trials, ensuring compliance with regulatory standards and industry guidelines. Acts as MedDRA and WHODrug SME for coding teams and cross functional study team stakeholders. Adept at collaborating with clinical and data management teams to streamline coding processes and improve operational efficiency. Committed to continuous professional development and staying current with evolving medical terminologies and coding systems to maintain the highest standards of quality in clinical data coding.

KEY TASKS & RESPONSIBILITIES

• Primary subject matter expert responsible for providing leadership and management responsibilities for medical coders and serious adverse event reconciliation to clients.
• Deliver best practices, technology, and innovative solutions
• Design and maintain Medical Coding Guidelines and Serious Adverse Event reconciliation plans in collaboration with sponsors
• Execute precise and consistent medical coding following coding guidelines and utilizing MedDRA and WHODrug dictionaries
• Conduct reviews for coding consistency including the approval of coded terms and synonym lists
• Enforce a versioning strategy and timeline for routine updates of industry standard dictionaries (MedDRA and WHODrug) in alignment with medical coding guidelines
• Assist in maintenance activities for coding tools, including User Acceptance Testing (UAT) script creation and execution
• Define requirements and collaborate with Data Engineers on development of tools and visuals for coding review and SAE reconciliation via elluminate®
• Ensure adherence to eClinical Solutions/industry quality standards, regulations, guidelines and procedures
• Preform serious adverse event reconciliation across clinical trial databases, safety systems and other relevant sources
• 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
• Participates in the development and/or maintenance of Standard Operation Procedures, Guidelines and/or Work Instructions documents as needed
• Other duties as assigned

Education & Experience

• Bachelor’s degree in relevant health science or professional qualification in a relevant scientific/technical discipline preferred
• 10+ 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
• Excellent team player
• 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