- 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