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Principal Clinical Data Standards – India
SEO-Optimized Meta Description
Join ICON as a Principal Clinical Data Standards Consultant in India. Hybrid role. Apply your CDISC and clinical data management expertise in a global setting.
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clinical data standards jobs, CDISC consultant India, clinical research jobs Bangalore, clinical data management roles, pharma jobs Chennai, remote pharma jobs, hybrid clinical data jobs, SDTM CDASH ADaM define-XML
Principal Clinical Data Standards Consultant
Location: Bangalore / Chennai / Bengaluru
Job Type: Full-Time
Work Mode: Hybrid (Office/Remote)
Experience Required: Senior-level
Job ID: JR128621
Salary Range: Not Disclosed (Competitive Industry Standard)
Job Summary
ICON plc, a global leader in clinical research and healthcare intelligence, is seeking a Principal Clinical Data Standards Consultant for its operations in India. This strategic, hybrid role combines leadership in clinical data standardization with deep expertise in CDISC, SDTM, CDASH, and regulatory data submission frameworks. Join a team that’s shaping the future of drug development and data science in global trials.
Key Responsibilities
Develop tools to support CDISC, sponsor, and internal ICON data standards.
Define data collection standards and strategies across clinical trials.
Create and update training and reference documentation on SDTM, CDASH, ADaM, define-XML, and submission requirements.
Lead development and refinement of data management tools and SOPs.
Stay current with industry regulations (FDA, EMA) and integrate them into data standards practices.
Partner with cross-functional teams including biostatistics, programming, and regulatory affairs.
Required Skills & Qualifications
Bachelor’s degree in Life Sciences, Computer Science, or a related field (Master’s or PhD preferred).
Strong background in clinical data standards within the pharmaceutical or biotechnology industries.
Advanced proficiency in CDISC standards (SDTM, ADaM, CDASH) and tools.
Experience with define-XML, regulatory submissions, and data architecture.
In-depth understanding of global regulatory requirements including FDA and EMA guidelines.
Strong analytical, problem-solving, and documentation skills.
Excellent interpersonal and cross-functional collaboration capabilities.
Perks & Benefits
Competitive salary and performance-based incentives
Annual leave entitlements and global holiday policies
Comprehensive health insurance for you and your dependents
Retirement savings and financial planning support
24/7 access to global Employee Assistance Program (LifeWorks)
Life insurance coverage
Optional benefits tailored by location: childcare vouchers, gym discounts, bike-to-work schemes, wellness checks, and more
Company Overview
ICON plc is a world-renowned contract research organization (CRO) delivering outsourced development services to pharmaceutical, biotech, and medical device industries. Operating in over 100 countries, ICON is dedicated to accelerating clinical innovation and delivering real-world healthcare impact.
Work Mode
Hybrid (Office-based in Bangalore/Chennai with flexibility for remote work)
Call to Action
Ready to lead impactful clinical research through data innovation? If you're passionate about global clinical standards and want to work with a top-tier healthcare research company, apply now on ThePharmaDaily.com and make your expertise count at ICON.
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