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Principal Clinical Data Standards Consultant

2+ years
Not Disclosed
10 Sept. 2, 2025
Job Description
Job Type: Remote Education: Bachelor’s degree in Life Sciences, Computer Science, or a related field. 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

Job Title: Principal Clinical Data Standards Consultant

Job ID: JR128621
Location: Bangalore, Chennai, Bengaluru (Office-based or Remote)
Department: ICON Full Service & Corporate Support – Data Standards
Hiring Manager: Sunidhi Sinha


About ICON plc

ICON plc is a world-leading healthcare intelligence and clinical research organization. We are proud to foster an inclusive environment that drives innovation and excellence. Join us as we shape the future of clinical development.

🔗 ICON Careers


Position Overview

As a Principal Clinical Data Standards Consultant, you will play a key role in designing and implementing standards libraries for ICON and sponsor projects. You will bring deep expertise in CDISC and CDASH, and hands-on experience with platforms like Medidata Rave or Veeva Vault CDMS/EDC to develop high-quality data collection standards for global clinical trials.


Key Responsibilities

  • Develop and implement ICON’s standard libraries in accordance with CDISC, sponsor-specific, and ICON’s internal standards.

  • Lead the development and maintenance of clinical data management tools and processes.

  • Collaborate cross-functionally to define clinical data collection strategies and standards.

  • Represent data standards in standards governance meetings and other strategic discussions.

  • Create and maintain training materials and reference documentation related to standards (e.g., CDASH, SDTM, Controlled Terminology, ADaM, define-XML).

  • Stay updated on industry trends and regulatory updates (FDA, EMA) and incorporate them into ICON’s standards framework.


Candidate Requirements

Education

  • Bachelor’s degree in Life Sciences, Computer Science, or a related field.

  • Advanced degrees are a plus.

Experience & Skills

  • Extensive experience in clinical data management and standards within the pharmaceutical, CRO, or biotech industry.

  • Strong hands-on experience in:

    • CDISC standards (CDASH, SDTM, ADaM)

    • Medidata Rave EDC and/or Veeva Vault CDMS/EDC

  • Knowledge of regulatory submission standards (FDA, EMA).

  • Excellent analytical, problem-solving, and attention-to-detail skills.

  • Strong interpersonal, collaboration, and communication abilities.

  • Proven ability to contribute to operational excellence and departmental strategy.


What ICON Offers You

ICON believes that high performance is best supported by a culture that rewards, supports, and develops its people. That’s why we provide a competitive salary, excellent benefits, and professional growth opportunities.

Benefits Include:

  • Annual leave entitlements based on location

  • Health insurance tailored for employees and families

  • Retirement savings plans to support long-term financial health

  • Global Employee Assistance Programme (LifeWorks) for 24/7 well-being support

  • Life assurance

  • Country-specific flexible benefits, such as:

    • Childcare vouchers

    • Bike purchase programs

    • Gym membership discounts

    • Subsidized travel passes

    • Health screenings

🔗 Explore ICON Benefits


Diversity & Inclusion at ICON

Inclusion and belonging are at the heart of ICON’s values. We are committed to providing a discrimination- and harassment-free workplace, promoting diversity across all levels.

All qualified applicants will receive equal consideration, regardless of:

  • Race, color, religion, sex, sexual orientation, gender identity

  • National origin, disability, or protected veteran status

If you require a reasonable accommodation due to disability or a medical condition during any part of the hiring process:
🔗 Submit a Request


Not Sure You Meet All Requirements?

That’s okay — if you're passionate about this role and aligned with ICON's mission, we encourage you to apply anyway. You may be the right fit for this or another opportunity.


Apply Now

📍 Location: Bangalore, Chennai, Bengaluru (Remote/Office-based)
📩 Hiring Contact: Sunidhi Sinha – Hiring Manager
🔗 ICON Careers Portal