Clinical Coder II at Syneos Health
About Syneos Health: Syneos Health is a leading biopharmaceutical solutions organization committed to accelerating customer success. By translating clinical, medical affairs, and commercial insights into tangible outcomes, the company addresses modern market realities with a focus on simplifying and streamlining processes. Syneos Health is dedicated to fostering innovation and delivering therapies that change lives.
Job Responsibilities:
Coding and Quality Control:
Experience in coding for multicenter, large clinical trials.
Lead experience in coding preferred, including the ability to manage and ensure the quality of coding listings.
Conduct quality checks (QC) of coded data and ensure consistency.
Understand and apply coding regulatory requirements, as well as protocol-related dependencies.
Experience with coding tools such as Thesaurus Management System (TMS), RAVE Coder, and Inform Central Coding.
Participate in coding setup activities and user acceptance testing (UAT).
Clinical Trial and Data Management:
Sound knowledge of the clinical trial process and data management activities, including query management and Serious Adverse Event (SAE) reconciliation.
Review coding data transfer and data management systems (DMBS).
Collaboration and Communication:
Interface effectively with sponsors and internal stakeholders at all levels to ensure smooth coding processes and project success.
Strong communication skills to manage relationships and inform stakeholders about the progress and issues in the coding process.
Project Management:
Ability to manage multiple priorities in a fast-paced, dynamic environment.
Contribute to the organization’s matrix-structured approach to project management.
Qualifications:
Education:
BS/BA degree preferred in Biological Sciences, Healthcare, Clinical Research, or a related field.
Experience:
3+ years of hands-on experience in medical coding, specifically in multicenter clinical trials.
Familiarity with WHODrug and coding tools such as TMS, RAVE Coder, and Inform Central Coding.
Knowledge of coding regulatory requirements, protocol-related dependencies, and clinical trial processes.
Skills:
Strong understanding of data management activities, query management, and SAE reconciliation.
Ability to handle multiple priorities in a dynamic environment.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and related software.
Excellent communication and interpersonal skills, both written and spoken.
Travel may be required (up to 25%).
Why Syneos Health?
Career Development:
Syneos Health fosters career development through ongoing training, mentorship, and professional growth opportunities.
Inclusive Culture:
The company is committed to a Total Self culture, where employees from diverse backgrounds, perspectives, and experiences are valued and can authentically be themselves.
Global Impact:
Syneos Health has supported 94% of all Novel FDA-approved drugs and 95% of EMA-authorized products, contributing to more than 200 studies across 73,000 sites globally.
Additional Information:
This job description is subject to change, and Syneos Health may assign additional tasks as needed. The company ensures compliance with the Americans with Disabilities Act and other relevant legislation to provide accommodations for employees where necessary.
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