Coding Specialist II
350 DNA Way, SSF35 South San Francisco, CA 94080
Bayside Solutions is seeking a Coding Specialist II to be part of our client’ s team in South San Francisco. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Coding Specialist II
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of 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 initiatives
Summary of Qualifications:
- BA/BS degree or equivalent in scientific, medical or relevant clinical discipline or a qualified healthcare professional will be considered.
- BSN, RN, RPh, Pharm D, PA or other applicable health professional degree is preferred.
- 3-4 years of experience in clinical research or a clinical setting.
- 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.