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Principal Clinical Data Standards Consultant

10-15 years
Not Disclosed
10 Oct. 13, 2025
Job Description
Job Type: Full Time Hybrid Education: B.Sc/M.Sc/M.Pharma/B.Pharma/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 Data Standards Consultant – ICON plc

Locations: Bangalore / Chennai / Bengaluru
Job ID: JR128681
Portfolio: Full Service & Corporate Support – Data Standards Consultant
Work Type: Office or Home / Remote


Company Overview

ICON plc is a world-leading healthcare intelligence and clinical research organization. We foster an inclusive environment that drives innovation and excellence, advancing the future of clinical development.


Role Overview

The Principal Clinical Data Standards Consultant is responsible for developing, implementing, and maintaining SDTM standards internally and for ICON’s sponsors. The role involves consulting, supporting technology tools for SDTM implementation, and providing technical leadership across standards governance and departmental initiatives.


Key Responsibilities

  • Develop and implement ICON’s standards libraries for SDTM mappings, including creating tools and macros.

  • Provide internal and external consulting on SDTM compliance and implementation.

  • Assist sponsors in developing, implementing, maintaining, and governing SDTM data standards content.

  • Support development and upkeep of technologies used for SDTM standards implementation.

  • Participate in standards governance team meetings and provide standards input as required.

  • Lead projects and mentor junior team members.

  • Apply business expertise to solve challenges and recommend best practices for product and service enhancement.


Required Education & Skills

  • Expert knowledge of SDTM, SDTM Implementation Guides, and Controlled Terminology.

  • Proficiency in R and SAS programming; familiarity with other languages is a plus.

  • 10–15 years of relevant experience in clinical data standards or related fields.

  • Strong problem-solving abilities with capacity to impact operational and departmental objectives.

  • Excellent interpersonal and communication skills, with the ability to adapt style, persuade effectively, and present complex analyses.

  • Leadership skills to contribute to departmental initiatives and guide team members.

  • Willingness to travel occasionally (<5%).


Benefits

ICON offers competitive compensation along with benefits focused on well-being and work-life balance, including:

  • Annual leave entitlements

  • Health insurance options for employees and families

  • Competitive retirement planning offerings

  • Global Employee Assistance Programme (LifeWorks, 24/7 access to specialized professionals)

  • Life assurance

  • Flexible, country-specific optional benefits (childcare vouchers, bike purchase schemes, gym memberships, subsidized travel passes, health assessments, etc.)

More details: ICON Careers Benefits


Diversity & Inclusion

ICON values inclusion and belonging. All candidates receive equal consideration regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Reasonable accommodations are available: Request here


Application Encouragement

Even if you don’t meet all requirements, you are encouraged to apply – you may be exactly what ICON is looking for.