Services will focus on providing cross functional and cross sectoral support in coding governance and associated processes. Additionally, services will focus on enabling the provision of consistent, accurate and reproducible coding of clinical study data and ensures adherence to established Janssen coding processes and guidelines by DM CRO vendors. Contribute to global thesaurus and code list maintenance, along with contributing to maintenance and enhancement of dictionary encoding products and systems is expected.

·        Services rendered will adhere to applicable Client SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc.

·        Executes and promotes adherence to established coding governance activities and principles.   

·        Contributes to delivery of consistent, accurate and reproducible coding of clinical trial data meeting individual project timelines.  

·        Knowledge sharing of coding processes and coding encoding systems with cross‐functional, colleagues including clinical trial teams and programming.  

·       Contributes to resolution of data coding issues. Addresses cross‐functional and cross-sectoral coding inquiries.   

·        Assists with SAE coding reconciliation.   

·        Identifies and appropriately reports coding tools/systems issues to EBIS and Head, Global Dictionary Management to ensure tools/systems are consistently available for IDAR and applicable external vendor users.  

·        Provides coding standards information and feedback to IDAR, DM CRO vendor partners and all clinical teams.  

·        Contributes to thesaurus development and maintenance including dictionary up‐versioning, synonym list maintenance, reclassification of terms and generation of reports within encoding system.  

·        Understands and utilizes encoding system functionality and tools to investigate system related coding issues.  

·        Contributes to maintenance of coding process documentation.  

·        Contributes to innovative ideas to enhance current coding landscape and increase effective coding e.g. by implementing automation 

·        Exhibits solid problem solving and decision‐making skills with input and support from Head, Global Dictionary Management.  

·        Contributes to innovative ideas to enhance current coding landscape and increase effective coding

Education and Experience Requirements/Qualifications:  

·        BS health related degree or professional experience equivalent is required.   

·        In‐depth knowledge of industry standard coding thesauri (MedDRA, WHO Drug) and the ability to utilize and contribute to the maintenance of incumbent dictionary encoding products and systems.   

·        A thorough understanding of clinical research processes and regulations.   

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com