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    Principal Clinical Coder

    Syneos Health
    10+ years
    Not Disclosed
    Remote
    10 Dec. 24, 2024
    Job Description
    Job Type: Full Time Education: BA/BS Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Principal Clinical Coder
    Company: Syneos Health®
    Location: Flexible

    About Syneos Health:
    Syneos Health is a fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We focus on clinical development, medical affairs, and commercial solutions to bring therapies to market faster. With our unique approach to supporting customers, we aim to make the processes easier for all involved while ensuring innovative outcomes that improve patient lives. Our global workforce of 29,000 employees across 110 countries reflects our passion for creating a diverse and inclusive work environment.

    Why Syneos Health?

    • Career Growth: Syneos Health offers career development, progression, and a peer recognition program that nurtures your growth.
    • Inclusive Culture: Our Total Self culture ensures everyone can be authentic at work, promoting a supportive and diverse environment.
    • Impactful Work: Join a company where your contributions matter globally in helping deliver therapies that change lives.

    Job Responsibilities:

    • Lead Experience in Large Studies: Proven expertise in managing and leading coding activities in large, multicenter clinical studies.
    • Collaboration with Sponsors: Act as the primary point of contact for sponsor counterparts on coding conventions, specifications, and decision-making processes.
    • Analytical Expertise: Conduct trend analysis and provide insights on consistency and QC findings, ensuring accuracy across all coding processes.
    • Coding QC Leadership: Lead the coding QC process, ensuring high standards and consistency across coding efforts.
    • Resource Management and Tool Development: Manage coding resources, assist in pricing and bidding processes, and lead coding tool development efforts.
    • Metrics and KPI Management: Assist coding management with overall metrics, tracking, and key performance indicators for coding operations.
    • Extensive Dictionary Knowledge: Deep understanding of SDGs, SMQs, and the processes related to dictionary up-versioning and reversioning.
    • Coding Tools and Process Expertise: Act as a subject matter expert (SME) on coding tools, including the setup, implementation, and management of these tools in clinical trials.
    • Collaboration Across Teams: Liaise with data management, programming, and safety teams for all coding-related processes and deliverables.
    • Safety Coding: Extensive experience with safety coding processes, including MedDRA and WHODrug dictionaries.
    • Meetings and Representation: Represent the coding team at national and international meetings, ensuring alignment with industry standards and protocols.

    Qualifications:

    • Education:
      • BS/BA degree in Biological Sciences, Healthcare, Clinical Research, or a related field is preferred.
    • Experience:
      • 10+ years of strong medical coding experience in clinical trials.
      • Expertise in MedDRA (LSMV), both safety and non-safety coding, is a must.
      • WHODrug experience is required.
      • Experience in Safety Coding TMS (Thesaurus Management System), including dictionary cleanup, repository maintenance, and reference sourcing.
    • Certifications:
      • MedDRA certification is a plus.
    • Skills:
      • Strong communication and interpersonal skills, with the ability to inform and collaborate effectively with internal and external stakeholders.
      • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
      • Ability to manage multiple priorities in a dynamic, fast-paced environment.
    • Travel:
      • Ability to travel up to 25% as needed.

    Why Join Us?

    • Lead the Way: Play a pivotal role in coding activities for large-scale studies, shaping the success of clinical trials.
    • Global Impact: Syneos Health has worked with 94% of all Novel FDA-approved drugs and 95% of EMA-authorized products, supporting over 200 studies worldwide.
    • Supportive Culture: Be part of a collaborative and inclusive environment that encourages personal and professional development.

    Syneos Health is committed to creating an inclusive environment and is an equal opportunity employer. We provide reasonable accommodations for qualified individuals with disabilities to perform the essential functions of the job.

    Apply now and be part of a team making a difference in the lives of patients worldwide.

    Learn more about careers at Syneos Health: Syneos Health Careers.

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