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Job Field: Legal Jobs
Location: United States, CA
Salary: $Not stated

JOB SUMMARY:

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<tr><td valign="top" width="450"><b>Job ID:00403226Job170of371Sr Clinical Coding SpecialistSouth San Francisco, CaliforniaJob factsJob functionBiometrics / BiostatisticsLocationUnited States - CaliforniaSouth San FranciscoCompany / DivisionPharmaceuticalsScheduleFull-timeJob typeRegular EmployeeJob levelExperiencedServiceDirect linkApply OnlinePrintWho We AreAt the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we''ve become one of the world''s leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.The PositionDescription:The Senior Clinical Coding Specialist is accountable for the delivery of all Thesaurus Management activities, including coding clinical and safety data using standard dictionaries in accordance with company and industry coding conventions.Responsibilities:- 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 initiativesRequirements:- 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

KEY REQUIREMENTS:

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