Principal Clinical Coder at Syneos Health
About Syneos Health: Syneos Health is a leading biopharmaceutical solutions organization that accelerates customer success. With a focus on clinical, medical affairs, and commercial insights, the company seeks to simplify processes and bring therapies to market faster. Syneos Health prioritizes collaboration, innovation, and a commitment to improving lives globally.
Job Responsibilities:
Leadership and Experience in Multicenter Trials:
Proven experience leading multicenter, large-scale clinical studies.
Liaison with sponsor counterparts on coding conventions, specifications, and decision-making processes.
Lead the coding quality control (QC) process, ensuring accuracy and consistency across datasets.
Technical Expertise in Coding:
Extensive knowledge of dictionaries (e.g., WHODrug, MedDRA), coding processes, browsers, and up-versioning/reversion processes.
Lead the setup and implementation of coding tools and ensure the quality of coding deliverables.
Expertise in SDGs (Standardized Data Groupings) and SMQs (Standardized MedDRA Queries).
Define coding specifications, dictionary schemas, and auto-coding algorithms.
Assist with the management of coding metrics and key performance indicators (KPIs).
Collaboration and Process Management:
Liaise with data management, programming, and safety teams for seamless integration of coding processes.
Serve as a subject matter expert (SME) for coding tools and processes, representing the coding team in cross-functional meetings.
Lead discussions at national and international meetings to represent coding activities.
Regulatory and Safety Coding:
Strong experience in MedDRA LSMV (Safety) and non-safety coding.
MedDRA certification is a plus.
Experience with TMS (Thesaurus Management System) for safety coding, including dictionary cleanup, repository maintenance, and reference sourcing.
Qualifications:
Education:
BS/BA degree in Biological Sciences, Healthcare, Clinical Research, or a related field.
Experience:
10+ years of experience in medical coding with a strong background in MedDRA (LSMV) and WHODrug.
Experience in coding resource management, pricing, bidding, and coding tool development is preferred.
Proficiency in managing multiple priorities and navigating a dynamic environment.
Previous experience in a matrix-structured organization is a plus.
Skills:
Strong interpersonal and communication skills, with the ability to inform stakeholders at all levels.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and related tools.
Ability to travel as necessary (up to 25%).
Why Syneos Health?
Career Development:
Syneos Health emphasizes professional growth, with career development opportunities, mentorship, and training in technical and therapeutic areas.
Inclusive Culture:
The company promotes a "Total Self" culture, where employees are encouraged to bring their authentic selves to work, fostering an environment of belonging and inclusivity.
Global Impact:
Syneos Health has played a role in the approval of 94% of all Novel FDA drugs and 95% of EMA-authorized products over the past five years.
Additional Information:
This job description is subject to change, and Syneos Health may assign additional tasks and responsibilities as needed. The company ensures compliance with all relevant employment legislation and is committed to providing reasonable accommodations when required.
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