Description
Duties:- Codes medical and treatment data reported to clinical trials/drug safety using standard dictionaries
- Identifies inadequate, ambiguous or unclear medical terms/medications and generates coding queries
- Conducts clinical literature searches to address coding issues and/or to enable coding process
- Performs QC on medical coding for accuracy and consistency and ensures it conforms to corporate and regulatory standards for submission
- Represents and provides thesaurus-related expertise to Study Management Teams (SMTs) and interacts with SMT to resolve coding issues and ensure timely, quality coding
- Provides input to protocol and eCRF/CRF development to ensure medical coding standards are upheld, coding data is captured as intended for analysis and subsequent data handling problems are avoided
- Manages coding-related clinical data management activities performed at service providers to ensure delivery against contracted scope of work
- -Researches and presents coding issues to the Thesaurus Steering Committee for consideration and agreement
- Maintains dictionary databases to ensure safety data is coded consistently in accordance with corporate standards and meets regulatory requirements
- Identifies and initiates requests for new medical terms and/or changes to the dictionary hierarchy
- Promotes awareness and delivers training on processes and coding guidelines to data management, SMTs, cross-functional groups, service providers, monitors and investigators as appropriate
- Leads or participates in the local functional/cross-functional implementation of best practices and process improvement initiatives
Skills
- Ability to work independently
- Strong leadership skills, including the ability to take ownership for decision making and outcomes
- Strong presentation, negotiation and networking skills
- Clinical or industry experience with an emphasis in coding clinical data and pharmacovigilance
- Understanding of clinical coding conventions, coding dictionaries and MedDRA
- Understanding of ICH, GCP, and other regulations related to CDM and industry conventions
- Clinical Data Management system experience (TMS, Rave experience is preferred)
- Understanding of a clinical research department's role in drug development
Education
- BSN, RN, RPh, Pharm D, PA or other applicable health professional degree is preferred
- BA/BS degree or equivalent in scientific, medical or relevant clinical discipline or a qualified healthcare professional will be considered
- 3-4 experience in clinical research or a clinical setting