01Overview
Job Description:
Deliver timely consistent, accurate and reproducible coding of clinical trial data using industry standard coding dictionaries (MedDRA, WhoDrug) in line with global and therapeutic area guidelines.In collaboration with Global Data Manager, develop trial coding specifications in line with trial requirements defining coding elements, dictionary versions and review timelines.Complete and submit Medidata Project Registration requests.Request and maintain appropriate access to coding systems.Perform independent quality control of trial data coding.Prepare and transmit trial data coding for consistency and accuracy review per trial coding specification.Address coding issues or revisions resulting from coding QC or consistency and accuracy review implementing coding reclassifications where required.Perform post-coding dictionary up-versioning synonym and coding reconciliation to align coding to latest dictionary versions.Initiate sign-off of final trial coding prior to reporting activities (DBL, Interim Analysis).
Education and Experience Requirements/Qualifications:
Base Level
Bachelors degree or equivalent, preferably in Health Sciences.Minimum of 3 years Clinical Data Coding experience in support of clinical research.Indepth knowledge of industry standard coding thesauri (MedDRA, WHO Drug) and the ability to utilize incumbent dictionary encoding products and systems.Experience working clinical trial .
