Principal Clinical Data Standards Specialist – Novartis, Hyderabad (On-site)
Job Summary:
Novartis is seeking a Principal Clinical Data Standards Specialist to lead the design, development, and implementation of global clinical data standards, automation technologies, and analytical reporting tools that support early and late-phase clinical trials. This is a high-impact role for experienced data and standards professionals looking to shape the data integrity and scientific rigor of global research and development programs.
Key Responsibilities:
Lead the planning and implementation of industry-compliant clinical data standards (CDISC, Define.xml).
Develop and maintain EDC tools including CRFs, edit checks, derivations, and configurations.
Translate user needs into functional requirements for dashboards and review reports.
Act as a subject matter expert for metadata, automation tools, and analytical data environments.
Coordinate validation and rollout of data review tools, ensuring high quality and compliance.
Collaborate with cross-functional teams including clinical programmers, statisticians, and medical writers.
Author user requirements, testing scripts, and documentation for all clinical data solutions.
Drive training, change management, and stakeholder engagement for new tools and processes.
Required Skills & Qualifications:
Strong background in clinical trials, clinical data management, and biostatistics.
Proficiency in metadata management, clinical automation, report programming, and visualization tools.
Deep understanding of CDISC standards, EDC platforms, and clinical data workflows.
Experience with functional specifications, project planning, and stakeholder alignment.
Prior exposure to working in a global pharma R&D or CRO environment.
Excellent collaboration, communication, and documentation skills.
Fluency in English (oral and written).
Perks & Benefits:
Access to Novartis Life Handbook with industry-leading professional and personal rewards.
Opportunity to work on cutting-edge drug development and data science initiatives.
Inclusive work environment that supports career development and growth.
Employee-friendly policies and global exposure.
Full-time regular employment with long-term career potential.
Company Description:
Novartis Healthcare Pvt. Ltd. is a global pharmaceutical leader committed to reimagining medicine to improve lives. With operations across over 150 countries, Novartis focuses on innovation in drug discovery, clinical research, and medical technology to bring transformative therapies to patients worldwide.
Work Mode: On-site (Hyderabad Office)
Advance Data Science in Clinical Research – Apply Now
Join Novartis to lead innovation in clinical data standards and automation. Take your data management expertise to the next level in global clinical development.
Apply today at: https://www.novartis.com/careers
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