Senior Clinical Coder at Syneos Health
About Syneos Health: Syneos Health is a leading biopharmaceutical solutions organization dedicated to accelerating customer success by translating clinical, medical affairs, and commercial insights into impactful outcomes. The company's approach to Clinical Development focuses on the customer and patient at the center of everything they do, with a commitment to simplifying and streamlining processes.
Job Responsibilities:
Leadership and Mentorship:
Lead large multicenter clinical trials and manage the coding process.
Mentor and guide junior coders, ensuring high-quality work and professional growth.
Lead coding QC processes and provide mentorship on best practices in coding.
Coding and Quality Control:
Take responsibility for coding in clinical trials, ensuring adherence to coding conventions and specifications.
Analyze trends in quality control (QC) and address consistency findings in data.
Oversee coding setup activities, including user acceptance testing (UAT), dictionary versioning, and reversion processes.
Collaboration and Communication:
Liaise with sponsors on coding conventions, specifications, and coding decision processes.
Represent Data Management and Coding at national and international meetings.
Manage relationships with sponsors and internal stakeholders, ensuring effective communication.
Technical Expertise:
Ensure proper setup and implementation of coding tools, including dictionary management (e.g., WHODrug, MedDRA).
Experience in defining coding specifications, dictionary schema, and auto-coding algorithms.
Oversee dictionary cleanup and repository maintenance through TMS (Thesaurus Management System) approval processes.
Project Management and Resource Management:
Oversee coding resource management, pricing, bidding, and tool development for coding activities.
Manage multiple priorities in a dynamic environment, ensuring deadlines and quality standards are met.
Qualifications:
Education:
BS/BA degree in Biological Sciences, Healthcare, Clinical Research, or a related field.
Experience:
7+ years of strong medical coding experience, with a focus on WHODrug and MedDRA (LSMV safety and non-safety coding).
Proven experience in coding for multicenter, large clinical trials.
Expertise in drug safety and understanding of the regulatory environment.
Skills:
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Strong communication and interpersonal skills, both written and verbal, to interact effectively with sponsors and internal stakeholders.
Ability to manage multiple projects and work in a matrix-structured environment.
Preferred:
Experience with coding resource management, pricing, bidding, and tool development.
Experience in Thesaurus Management System (TMS) approval and dictionary management.
Travel may be required (up to 25%).
Why Syneos Health?
Career Development:
Syneos Health is committed to fostering professional growth through career development programs, mentorship, and recognition.
Inclusive Culture:
The company emphasizes a Total Self culture, celebrating diversity and creating a workplace where everyone can be themselves.
Global Impact:
Syneos Health has contributed to the success of 94% of all Novel FDA-approved drugs and 95% of EMA-authorized products, impacting clinical trials across thousands of sites globally.
Additional Information:
This job description may evolve over time as business needs change. Syneos Health may assign additional tasks as necessary and offers accommodations for employees with disabilities. The company is committed to complying with all relevant legislation, including the EU Equality Directive and the Americans with Disabilities Act.
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