Medical Coder
Core
Lead medical coding resource for clinical trials, ensuring accuracy of coding practices and reconciliation of serious adverse events (SAEs).
Role type
Senior Medical Coder (Clinical Trials)
Builds
Accurate medical coding datasets and SAE reconciliation reports for clinical trial sponsors
Domain
Pharmaceutical/Biotechnology, Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
Medical coding (WHODrug, MedDRA), SAE reconciliation, ICH/GCP guidelines, 21 CFR Part 11, clinical trial methodology, EDC systems, UAT script creation
Preferred skills
Medidata Rave Coder experience, dictionary up versioning workflow, coding tool deployment
Technologies
MedDRA, WHODrug, elluminate, Medidata Rave, Microsoft Office
Responsibilities
Design and maintain Medical Coding Guidelines and SAE reconciliation plans, Perform precise medical coding following guidelines, Conduct reviews for coding accuracy and consistency, Perform serious adverse event reconciliation across databases, Generate coding/SAE queries, Collaborate with safety and clinical teams to resolve discrepancies, Document coding decisions and justifications, Assist in maintenance of coding tools including UAT, Participate in MedDRA and WHODrug dictionary up versioning, Perform testing of coding tool and deployment of listings, Ensure compliance with industry standards and regulations
Seniority
Senior, hands-on IC