Senior Medical Coding Specialist
Core
Ensure accurate and consistent coding of medical data for clinical trials, including independent review of third-party coded data and oversight of outsourced CRO work.
Role type
Senior Medical Coding Specialist (Clinical Trials)
Builds
Clinical trial data quality and regulatory compliance for pharmaceutical/biotech sponsors
Domain
Clinical Research / Life Sciences
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical coding (MedDRA, WHO Drug Dictionaries), ICH/GCP guidelines, scientific operations, vendor oversight, training documentation, CDM documents, data warehouse tools
Preferred skills
Coding applications (Veeva, Medidata RAVE Coder), Clinical Data Management processes, regulatory requirements
Technologies
MedDRA, WHO Drug Dictionaries, Veeva, Medidata RAVE Coder, Elluminate, CORE
Responsibilities
Provide independent review of data coded by third parties; Oversee work outsourced to CRO through medical coding review and synonym dictionaries review; Participate in the review and maintenance of guidance and training documentation for coding guidelines; Support other departments concerning dictionary use and coding quality; Collaborate on the creation and maintenance of CDM documents referencing coding related activities; Support and manage MedDRA and WHO Drug Dictionary upversion activities
Seniority
Senior, hands-on IC with mentorship
