Job Title: Principal Clinical Data Standards Consultant
Location: Bengaluru, Bangalore, Chennai (Hybrid: Office/Remote)
Job ID: JR128681
Department: ICON Full Service & Corporate Support – Data Standards
Company Overview:
ICON plc is a global leader in healthcare intelligence and clinical research. We are committed to fostering an inclusive environment that drives innovation, collaboration, and excellence in clinical development.
Role Summary:
As a Principal Clinical Data Standards Consultant, you will play a critical role in designing and managing the implementation of data standards that support high-quality clinical trials. You will work closely with cross-functional teams and contribute to the development of innovative therapies by ensuring data is collected, structured, and interpreted efficiently and accurately.
Key Responsibilities:
Develop tools to support the implementation and compliance with CDISC, Sponsor, and ICON standards
Collaborate with cross-functional teams to define clinical data collection strategies and standards
Create and maintain training and reference materials covering:
CDASH
SDTM
Controlled Terminologies
ADaM
Define-XML
Regulatory submission requirements
Manage and enhance data management processes and tools
Stay updated on industry trends and regulatory changes, and incorporate them into ICON’s practices
Qualifications & Experience Required:
Bachelor's degree in Life Sciences, Computer Science, or related field (advanced degrees are an advantage)
Extensive experience in clinical data management and standards within pharmaceutical or biotechnology sectors
Advanced proficiency in CDISC standards and knowledge of global regulatory requirements (e.g., FDA, EMA)
Strong analytical and problem-solving skills with attention to detail
Excellent interpersonal and communication skills to effectively work across teams
What ICON Offers:
ICON provides a competitive and comprehensive benefits package, supporting your professional and personal well-being:
Attractive salary with various annual leave options
Flexible health insurance packages tailored to individual and family needs
Strong retirement planning benefits
Global Employee Assistance Programme (LifeWorks) – 24/7 mental health and well-being support
Life assurance coverage
Flexible, country-specific optional benefits including:
Childcare vouchers
Bike purchase schemes
Discounted gym memberships
Subsidised travel passes
Health assessments
More information available at: ICON Careers Benefits
Commitment to Diversity & Inclusion:
ICON is dedicated to maintaining a workplace that values diversity and inclusion. All qualified applicants will be considered regardless of race, religion, gender, sexual orientation, disability, or veteran status.
Need accommodation? Submit a request here: ICON Reasonable Accommodations
Think you're not 100% qualified? Apply anyway – we want to hear from you.
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