Principal Medical Coding Specialist

Principal Medical Coding Specialist

Statistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials.

Job Summary

Manages the medical coding activities for multiple projects, including coding of clinical terms, dictionary subscription management and selection, validation, implementation and management of coding systems. Ensures medical coding practices are in compliance with US and OUS regulatory requirements. Responsible for training, mentoring staff on medical coding practices Ensures coding is performed accurately and consistently by other medical coding staff.

Primary Responsibilities

• Author and revise SDC medical coding SOPs and Work Instructions as needed to ensure they are in compliance of regulatory requirements

• Serve as a subject matter expert on use of medical dictionaries and coding practices to project team and clients

• Provide guidance to clients on medical dictionary subscription requirements

• Manage dictionary subscriptions versions for current projects

• Mentor and train additional staff on medical coding processes as necessary

• Assign and balance coding activities amongst medical coding staff and review coding for consistency across studies

• Work on various EDC systems to perform medical coding activities

• Stay current with industry medical coding standards and innovative tools

• Assess impact of dictionary changes and the impact on projects

• Work with lead data manager and biostatistician to define project dictionary up-version strategies

• Represent SDC in internal and external audits on medical coding process expert

• Work with Clinical Programmers to develop and test project coding database and ensure User Acceptance Testing (UAT) on medical coding fields is successfully completed

• Assist Business Development on pricing and timing of coding only projects

• Act as project lead on coding only projects and submissions

• Review project medical coding requirements and communicate to appropriate team members to ensure compliance

• Contribute and approve the Medical Coding Convention section of the Data Management Plan

• Post queries on clinical database as needed to ensure accurate medical coding

• Provide status and medical coding counts on all projects

• Adhere to all aspects of the SDC’s quality system

• Comply with SDC’s data integrity & business ethics requirements

• Perform other related duties as assigned

• Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Required Skills

• Exceptional working knowledge of clinical trials and coding specialist role in the drug development process

• Excellent organizational skills

• Highly effective communication skills, both written and verbal

• Technical skills including: MedNet and Medidata Coder or other coding systems, Microsoft Office

• Ability to work as a part of a team and independently

• Ability to work under tight timelines

Education or Equivalent Experience

• Bachelor’s degree in applied or life science and 8-10 years of experience in clinical data management field.

• Minimum of 5 years of experience in coding with WHODrug and MedDRA.

• Minimum of 3 years of experience leading medical coding projects. Certified Medical Coder through MSSO preferred.

Why SDC

SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team members to develop great medicines that save lives and cure diseases in the most efficient manner possible. Our global team operates as a value partner to our clients by fulfilling their needs as our own and delivering exceptional results. We are a specialty CRO in that we provide scalable service offerings, focused services area specialists, efficient project timelines, optimal technology solutions, and proven success and experience. Our commitment to our clients is the same commitment to our employees. By offering strong benefits including competitive pay, generous time off, attainable career advances and positive work/life balance, we are able to attract some of the most talented people in the industry.

• We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits.

• We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment.

• We strive to provide a place of belonging to our employees with fun and engaging activities from SDC’s culture club.

• We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry.

• With a proven track record, SDC has been successfully executing client clinical programs since 2005.

Take a look at how you can join our team!

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