• 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:
• Bachelor’s degree or equivalent, preferably in Health Sciences.
• Minimum of 3 years’ Clinical Data Coding experience in support of clinical research.
• In‐depth knowledge of industry standard coding thesauri (MedDRA, WHO Drug) and the ability to utilize
incumbent dictionary encoding products and systems.
• Experience working clinical trial