Principal Clinical Data Standards Consultant
Locations: Bangalore, Chennai, Bengaluru
Job ID: JR128681
Department: ICON Full Service & Corporate Support – Data Standards Consultant
Work Model: Office or Home (Remote Option Available)
About the Role
ICON plc is a world-leading healthcare intelligence and clinical research organization dedicated to innovation, excellence, and diversity. As a Principal Clinical Data Standards Consultant, you will play a strategic role in shaping and implementing CDISC SDTM standards to support both internal initiatives and global sponsor projects.
You will provide technical leadership, consultation, and governance for data standardization, SDTM implementation, and programming automation, ensuring compliance and consistency across clinical data processes.
Key Responsibilities
Develop and implement ICON’s internal SDTM standards libraries, including tools and macros for seamless data mapping.
Provide consulting services on SDTM compliance, data mapping, and implementation for both internal teams and external sponsors.
Support sponsors in developing, maintaining, and governing their clinical data standards content.
Contribute to the design and maintenance of technologies and systems that support SDTM standards implementation.
Participate in standards governance committees and offer expert input on data standardization strategies.
Lead departmental initiatives, mentor junior programmers and standards specialists.
Collaborate with internal stakeholders to ensure alignment with industry best practices and regulatory expectations.
Apply business and technical expertise to recommend improvements and optimize standardization processes.
Occasionally travel (<5%) to attend project meetings or governance discussions as required.
Required Qualifications & Experience
Education: Bachelor’s or Master’s degree in Life Sciences, Computer Science, Data Science, or related field.
Experience: 10–15 years of relevant experience in clinical data standards, SDTM programming, and data management.
Technical Skills:
Expert-level knowledge of SDTM standards, SDTM Implementation Guides, and Controlled Terminology.
Proficiency in SAS and R programming languages (other languages an advantage).
Experience with data standardization tools, automation macros, and standards governance frameworks.
Strong analytical and problem-solving skills with proven ability to impact operational objectives.
Excellent leadership, mentoring, and cross-functional collaboration capabilities.
Exceptional communication and stakeholder engagement skills.
Experience Level
Senior to Principal Level
Typically 10–15 years of experience in clinical data standards, programming, and governance roles.
Job Category
Primary Category: Clinical Data Standards / Clinical Programming
Subcategories:
CDISC Standards Development (SDTM, ADaM)
Data Governance and Compliance
Programming and Automation
Data Standardization Consulting
What ICON Can Offer You
ICON is committed to building a culture that rewards performance and nurtures growth. We offer competitive compensation and benefits tailored to support your well-being and career development.
Examples of Benefits:
Comprehensive annual leave entitlements
Diverse health insurance plans for you and your family
Competitive retirement savings and financial planning options
Global Employee Assistance Programme (LifeWorks) with 24/7 support access
Life assurance coverage
Country-specific optional benefits such as:
Childcare vouchers
Bike purchase schemes
Discounted gym memberships
Subsidized travel passes
Health assessments
Gujarat :
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Copenhagen | Denmark |Europe :
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Wavre |Tipperary :
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China | Quarry Bay |Liaoning :
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Hangzhou |Tokiyo :
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Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Mississauga | North York | Australia | Uxbridge | Renfrew | Richmond Hill |Canada :
Canada |Quebec :
Montreal |Brussels :
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Zaventem |South America :
Argentina | Peru |Brazil :
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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
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Japan | Saitama |Tokyo :
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