Principal Clinical Data Standards Specialist – Novartis, India
Job Summary:
Novartis is hiring a Principal Clinical Data Standards Specialist in Hyderabad, India, to drive implementation of clinical data standards aligned with CDISC and regulatory guidelines. This strategic role bridges scientific research and clinical development with cutting-edge data review solutions, empowering global drug development operations. If you're passionate about transforming data into actionable clinical insights in a regulated pharma environment, this opportunity is for you.
Key Responsibilities:
Lead design, planning, and rollout of CDISC and regulatory-compliant clinical data standards.
Translate complex business requirements into logical models and reporting specifications.
Develop and drive implementation of data analytics dashboards for clinical data review.
Serve as key liaison between users, programmers, and project stakeholders for data delivery.
Author user requirements, functional specifications, and testing scripts.
Coordinate cross-functional project delivery and ensure compliance with internal policies.
Champion change management, user training, and rollout for new data review tools.
Ensure adherence to timelines, KPIs, and reporting obligations.
Required Skills & Qualifications:
Proven experience in clinical trials, clinical data standards, or clinical data management.
Hands-on knowledge of CDISC, SAS, R, and metadata/data standards tools.
Strong background in statistical analysis, automation, and clinical operations.
Excellent ability to translate scientific/technical needs into system requirements.
Experience in cross-cultural and boundary-spanning collaboration.
Proficiency in English (spoken and written).
Perks & Benefits:
Competitive salary and performance-based bonuses (not specified in JD).
Access to comprehensive learning and development programs.
Inclusive and diverse workplace culture.
Health and wellness benefits.
Global mobility and career growth opportunities.
Company Overview:
Novartis Healthcare Pvt. Ltd. is a global leader in innovative medicines, committed to reimagining medicine to improve and extend people’s lives. With robust investments in clinical research, data-driven healthcare, and biomedical innovation, Novartis offers a unique platform for professionals seeking to make a measurable impact in global health.
Work Mode: On-site – Hyderabad, India
Call-to-Action:
Ready to bring scientific rigor and data expertise to a global R&D powerhouse? Apply now to become a Principal Clinical Data Standards Specialist at Novartis and help shape the future of clinical development.
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