Senior Medical Coding Specialist

IconRaleigh, NC
106d

About The Position

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Medical Coder to join our diverse and dynamic team. The Clinical Coder 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, they support global thesaurus and code list maintenance. You will act as a key contributor in maintaining high-quality clinical data by collaborating with various teams to resolve coding issues and provide expert guidance on coding practices.

Requirements

  • 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.

Nice To Haves

  • Experience using Medidata Coder.

Responsibilities

  • In collaboration with Global Data Manager, develop trial coding specifications in line with trial requirements defining coding elements dictionary versions and review timelines.
  • Request and maintain appropriate access to coding systems.
  • Deliver timely consistent, accurate and reproducible coding of clinical trial data using industry standard coding dictionaries (MedDRA, WHO Drug) in line with global and therapeutic area guidelines.
  • Perform independent quality control of trial data coding.
  • Prepare and transmit trial data coding for consistent 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).
  • Perform coding UAT (study level set-up).

Benefits

  • Various annual leave entitlements.
  • A range of health insurance offerings to suit you and your family's needs.
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
  • Life assurance.
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
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