Senior Medical Coder

Job Description

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 Client?s 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.
Deliverables:
Contributes to the oversight of IDAR data coding activities to ensure adherence to Regulatory Authority and Industry standards for coding practices and processes:
? Services rendered will adhere to applicable company?s 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
? ADVANCED:
o Influences IDAR and cross-sector decisions related to coding processes and systems and
understands and aligns with long term and cross sector business needs.
o Understands and utilizes encoding system functionality and tools to investigate system related coding issues. Coordinates with appropriate Support teams to assist in resolution of issues.
o Contributes to thesaurus development and maintenance. Performs dictionary up- versioning, synonym approval.
o Exhibits excellent problem solving and decision-making skills with minimal supervision
o Contributes to, oversees and undertakes maintenance of coding process documentation.
o Coordinates dictionary enhancement requests to MSSO, UMC Uppsala
o Actively identifies opportunities and solutions to increase efficiency and quality of coding
and dictionary management.
Interfaces ? Primary/Other:
? Primary interfaces: Provider Functional Manager, Company?s Point of Contact, Head Global Dictionary Management
? Other Interfaces: Global Dictionary Management, IDAR, Clinical Teams, Data Standards, Data handling, EBIS, programming, biostatisticians, medical writing, DM CRO?s and coding system vendors
Education and Experience Requirements/Qualifications:
o BS health related degree or professional experience equivalent is required.
o In-depth knowledge of industry standard coding thesauri (MedDRA, WHO Drug) and the
ability to utilize and maintain incumbent dictionary encoding products and systems.
o A thorough understanding of clinical research processes and regulations.
o A minimum of 5 years thesaurus management experience is essential