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Principal Clinical Coder

10+ years
Not Disclosed
10 Dec. 30, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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
Updated: December 9, 2024
Location: India-Asia Pacific - IND-Home-Based, India
Job ID: 24006561

Job Description

Principal Clinical Coder

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes that address modern market realities.

Our Clinical Development model places the customer and the patient at the center of everything we do. We are continuously innovating to simplify and streamline our processes, not only making Syneos Health easier to work with but also creating a workplace that’s even more rewarding.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll work alongside passionate problem solvers, collaborating as a team to help our customers achieve their goals. We are agile, driven, and passionate about accelerating the delivery of therapies to change lives.

Discover why our 29,000 employees across 110 countries already know:
WORK HERE MATTERS EVERYWHERE

Why Syneos Health

At Syneos Health, we’re committed to developing our people through career progression, technical training, peer recognition, and a total rewards program. Our Total Self culture celebrates authenticity, where everyone can bring their true selves to work. Diversity of thought, background, and perspective creates an environment where everyone belongs.

Job Responsibilities

  • Lead experience in multicenter large studies and liaison with sponsor counterparts on coding conventions, specifications, and coding decision processes.
  • Analytical experience in trend analysis for quality control (QC) and consistency findings.
  • Lead the Coding QC process and coding resource management, including pricing, bidding, and tool development.
  • Assist in overall coding metrics and KPI management, ensuring compliance with coding specifications.
  • Extensive knowledge of Standard Data Groups (SDGs), SMQs, and dictionaries (MedDRA, WHODrug) along with dictionary versions and coding processes.
  • Collaborate with data management, programming, and safety teams for all processes involving coding.
  • Technical expertise in coding tool setup and implementation processes, including dictionary up-versioning and reversion.
  • Define coding specifications, dictionary schema, and auto-coding algorithms.
  • Serve as a Subject Matter Expert (SME) for coding tools and processes.
  • Manage DB QC, UAT, and other data management activities related to coding deliverables.
  • Represent the coding team at national/international meetings and in Data Management (DM) meetings.
  • Contribute to the development of coding specifications, tools, and quality assurance processes.

Qualifications

What We’re Looking For:

  • BS/BA degree preferred in biological sciences, healthcare, or clinical research.
  • 10+ years of strong medical coding experience with MedDRA, including both safety and non-safety coding.
  • MedDRA certification is a plus.
  • Strong experience with WHODrug and Safety Coding Thesaurus Management Systems (TMS).
  • Ability to effectively engage with sponsors and internal stakeholders at all levels.
  • Excellent communication and interpersonal skills, both written and verbal, with the ability to inform and influence.
  • Proven ability to manage multiple priorities in a dynamic, fast-paced environment.
  • Experience working in a matrix-structured environment is preferred.
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and communication tools.
  • Ability to travel up to 25% as necessary.

Get to Know Syneos Health

Over the past 5 years, we have worked with 94% of all novel FDA-approved drugs, 95% of EMA-authorized products, and conducted over 200 studies across 73,000 sites and 675,000+ trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health and the difference we’re making in the biopharmaceutical industry.

Additional Information

The tasks, duties, and responsibilities listed in this job description are not exhaustive. The company may assign additional tasks or responsibilities as necessary. Equivalent experience, skills, and/or education will be considered. All job descriptions comply with applicable legislation and ensure equal opportunities in recruitment and employment practices.