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Principal Clinical Data Standards Consultant

8-12 years
Not Disclosed
10 June 5, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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

 

Meta Title:

Principal Clinical Data Standards Consultant – Bangalore

Meta Description :

Join ICON as a Principal Clinical Data Standards Consultant in Bangalore. Lead CDISC compliance, innovate in clinical trials. Hybrid work model available.

Meta Keywords:

clinical data standards jobs, CDISC consultant Bangalore, pharma data jobs India, clinical research jobs 2025, ICON careers, data management pharma


Principal Clinical Data Standards Consultant – ICON plc (Bangalore/Chennai)

Location: Bangalore or Chennai
Job Type: Full-time, Hybrid (Office/Remote)
Job ID: JR128681

Job Summary

ICON plc is seeking a Principal Clinical Data Standards Consultant to join its global healthcare intelligence and clinical research organization. This role is perfect for experienced professionals in clinical data management, CDISC standards, and regulatory compliance, looking to influence global clinical trial strategies. You will collaborate with cross-functional teams, develop tools and training materials, and ensure compliance with evolving global standards.


Key Responsibilities

  • Develop tools to implement and enforce CDISC, sponsor, and ICON data standards.

  • Define clinical trial data collection strategies aligned with regulatory compliance.

  • Maintain training resources on CDASH, SDTM, ADaM, define-XML, and submissions.

  • Support data process design and tool development for data management.

  • Monitor global regulatory trends and ensure ICON’s standards evolve accordingly.


Required Skills & Qualifications

  • Bachelor's degree in Life Sciences, Computer Science, or a related field (Advanced degree preferred).

  • Extensive experience in clinical data standards within pharma or biotech.

  • Deep knowledge of CDISC (SDTM, ADaM, CDASH) and global regulations (FDA, EMA).

  • Experience with clinical trial systems and standards implementation.

  • Strong analytical, documentation, and cross-functional collaboration skills.


Perks & Benefits

  • Competitive base salary (exact compensation not disclosed; industry standard).

  • Generous annual leave entitlements.

  • Comprehensive health insurance options.

  • Retirement savings and planning programs.

  • Global 24/7 Employee Assistance Program (LifeWorks).

  • Optional perks: childcare vouchers, gym discounts, travel subsidies, and more.

  • Life assurance coverage.

  • Hybrid working environment for work-life balance.


Company Overview

ICON plc is a global leader in clinical research, pharmaceutical innovation, and healthcare intelligence. With a commitment to diversity and inclusion, ICON delivers high-impact solutions in drug development, clinical trials, and medical data compliance to transform global healthcare.


Work Mode:

Hybrid – Combination of remote and office-based work in Bangalore or Chennai.


Call to Action

Are you ready to play a vital role in shaping the future of clinical data strategy? Apply now and be part of an organization that values data excellence, compliance, and innovation in the pharmaceutical industry.

Apply Now on ICON Career: