ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

The Medical Coding Specialist performs activities relating to coding of clinical data aligned with Clinical Trial Protocol defined requirements for coding and using established global and therapeutic area coding guidelines and processes. In addition, you will support global thesaurus and code list maintenance. Activities are performed in close collaboration with Data Managers, Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS).

What you will be doing:

• 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).

You possess:

• 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 on clinical trials.
• Experience working in highly diverse teams within clinical research; cross-functional, global, multiregional.
• Working knowledge of GCP/ICH guidelines.
• Excellent written and verbal communication in English.