Clinical Coding Specialist - Immediate Need

Job type:
Start date:
12 months
Real Staffing
San Francisco
Published at:
flag_no USA
Project ID:

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  • 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

  • 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

  • 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