Title: Associate Director – Clinical Data Standards
Company: Novartis
Location: India
Job ID: REQ-10022081
Posted Date: April 29, 2025
Work Type: Full-time
Function: Clinical Data Management / Data Standards
Industry: Pharmaceuticals / Life Sciences
Job Summary:
This role supports the Director of Clinical Data Standards by strategically leading the planning, development, and implementation of clinical data standards and automation technologies. The Associate Director serves as a key expert and advisor across clinical systems, data tools, and regulatory-compliant standard practices, supporting both operational teams and governance boards.
Key Responsibilities:
Lead the planning, definition, development, and validation of clinical data standards and automation solutions
Act as primary SME for data standards and technologies within therapeutic areas or across global teams
Provide strategic oversight on implementation of CDISC and regulatory standards across systems
Manage governance processes and coordinate with relevant boards to ensure standard adoption and compliance
Conduct impact and gap analysis for industry/regulatory standard changes and develop implementation strategies
Mentor and provide technical leadership to Clinical Data Standards associates
Act as consultant to cross-functional areas including EDC design, IVR, ePRO, metadata management, and statistical reporting
Lead training, documentation, and communication efforts related to data standards, processes, and systems
Key Performance Indicators (KPIs):
Timely and high-quality execution of standard implementation projects
Stakeholder satisfaction and feedback
Compliance with Novartis standards and regulatory guidelines
Adherence to defined KPIs and metrics
Minimum Requirements:
Demonstrated experience in managing data standards within clinical trials
Strong knowledge of CDISC standards, metadata management, and automation tools
Proficiency in technologies such as EDC systems, edit check programming, data transfer specifications, and reporting tools
Effective project management and cross-functional collaboration skills
Experience in mentoring and technical guidance across teams
Strong understanding of statistical analysis, computer programming, and biostatistics
Fluent in English
Skills and Competencies:
Metadata Management and Clinical Data Standards
Automation and Programming
Statistical Analysis and Biostatistics
Decision-Making and Project Leadership
Cross-Functional Collaboration
Clinical Trial Process Understanding
Why Join Novartis:
Contribute to global health by supporting high-quality clinical data standards that power safe, effective medicine development. Join a mission-driven company shaping the future of medicine.
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