Senior Clinical Coder
Company: Syneos Health®
Location: Flexible
About Syneos Health:
Syneos Health is a fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success in clinical development, medical affairs, and commercial services. We focus on streamlining work processes, simplifying collaboration, and driving innovation. With a global presence in over 110 countries, we help bring new therapies to patients faster, with our commitment to people development, diversity, and inclusion at the heart of everything we do.
Why Syneos Health?
Career Growth: Opportunities for career development, progression, and peer recognition.
Inclusive Culture: A diverse work environment where everyone can be their authentic self, driven by our "Total Self" culture.
Global Impact: A dynamic, results-driven culture focused on changing lives and accelerating the delivery of therapies.
Job Responsibilities:
Leadership in Clinical Coding: Lead large, multicenter clinical trials, ensuring coding accuracy, quality control, and consistency across all data.
Collaboration with Sponsors: Work closely with sponsors on coding conventions, specifications, and decisions related to clinical trials.
Coding and Quality Control: Provide expert-level input into the coding QC process and trend analysis for data consistency and quality.
Mentorship and Team Leadership: Mentor junior coders and provide leadership within coding teams to ensure compliance with industry standards.
Tool Setup and Implementation: Oversee coding tool setup, including UAT (User Acceptance Testing) and dictionary version control (e.g., MedDRA, WHODrug).
Coding Specifications and Process Management: Lead the development and implementation of coding specifications, auto-coding algorithms, and dictionary schema.
Data Management Liaison: Collaborate with data management teams to ensure coding deliverables align with the overall data management and database lock processes.
Meetings and Presentations: Represent the data management and coding teams at national and international meetings and forums.
Qualifications:
Education:
BS/BA degree in Biological Sciences, Healthcare, Clinical Research, or a related field preferred.
Experience:
7+ years of strong medical coding experience in clinical trials.
Extensive experience with WHODrug and MedDRA coding, including safety and non-safety coding.
Proven leadership experience in coding teams and multicenter clinical trials.
In-depth knowledge of coding processes, database lock, and data management activities.
Technical Expertise:
Experience with TMS (Thesaurus Management System) approval, dictionary cleanup, and repository maintenance.
Familiarity with coding specification development, auto-coding algorithms, and up-versioning/reversioning processes.
Skills:
Strong communication and interpersonal skills, capable of dealing effectively with internal and external stakeholders.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Ability to manage multiple priorities in a dynamic, matrix-structured environment.
Travel:
Ability to travel up to 25% as required.
Why Join Us?
Make an Impact: Lead clinical coding activities that shape the success of large-scale clinical trials.
Global Reach: Work with a team that spans across 110 countries and has supported the approval of 94% of all Novel FDA Drugs.
Professional Development: Syneos Health is committed to fostering a supportive and dynamic environment for career progression.
Syneos Health is an equal opportunity employer, committed to creating an inclusive environment and providing reasonable accommodations for qualified individuals with disabilities.
Apply now to be part of a team that makes a difference in the lives of patients and accelerates the delivery of new therapies.
Learn more about careers at Syneos Health: Syneos Health Careers.
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