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
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
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