Coding Specialist II in South San Francisco, CA at Apex Life Sciences

Date Posted: 10/12/2018

Job Snapshot

Job 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 departments 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

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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