Senior Principal Clinical Data Scientist

Novartis AG; Hyderabad; On-site; INR 1,500,000 - 3,000,000; Full time

Job summary

Novartis AG in Hyderabad, India seeks an experienced Clinical Data Management leader to drive data management, data governance and data integration across multiple studies from phase I to IV. You will collaborate with cross-functional teams to ensure timely, high-quality data deliverables and scalable training delivery.

The role requires strong project management, data architecture expertise, and proven ability to implement consistent data handling procedures, protocols, and audit readiness

Qualifications

• Proven experience in clinical data management, data governance, data integration and data quality.
• Strong project management skills with multi-tasking ability.
• Cross-cultural experience in managing clinical data management activities.
• Ability to resolve protocol issues affecting database design, validation, and reporting.

Responsibilities

• Lead functional activities for medium to large studies from phase I to IV.
• Coordinate activities of Data Managers internally and externally.
• Make data management decisions and propose study-level strategies.
• Ensure consistent data management processes across projects and programs.
• Represent Data Operations in audits, inspections, and readiness activities.

Skills

Clinical Data Management

Data Governance

Data Integration

Data Quality

Data Architecture

Data Strategy

Job description

Job Description Summary -Responsible and accountable for managing all Data Mgmt/Coding / CDD/DAP aspects of several studies, a medium to large sized project or project level activities at a consistently high standard. The position is a key collaborator and strategic partner with stakeholders ensuring that pharmaceutical drug development plans in Novartis Global Drug Development are executed efficiently with timely and high quality deliverables. Conceptualize and implement, in a scalable way, appropriate training delivery models and platforms for end-to-end deliverables. Follows and oversees -Good Clinical Practices (GCP), data-handling procedures & guidelines. Ensure consistency across assigned program to aid efficiencies for submissionsParticipates in the review of clinical research protocols, reports and statistical analysis plans. Leads quality deliverables across platforms. Develops simple and reproducible strategies to ensure quality deliverables,

Job Description

Key Responsibilities

• Lead functional activities for medium to large-sized projects in phase I to IV clinical studies within the Novartis Global Development Organization.
• Coordinate activities of Data Managers, both internally and externally.
• Make data management decisions and propose strategies at the study or project level.
• Ensure the application of consistent data management processes, increasing standardization and documentation across assigned projects/programs.
• Provide and implement data management solutions, ensuring knowledge sharing.
• Lead process and training deliverables within multiple platforms, franchises, or therapeutic areas, developing strategies for effective training and knowledge retention.
• Represent Data Operations (DO) in all audits and inspections, centralizing and aligning the team in audit preparation, readiness, and response.

Essential Requirements

• Proven experience in clinical data management, data architecture, data governance, data integration, data profiling, data quality, data science, data strategy, and master data.
• Strong project management skills with the ability to manage multiple tasks and projects simultaneously.
• Cross-cultural experience and functional breadth in managing clinical data management activities.
• Ability to recognize and resolve protocol issues that may impact database design, data validation, and analysis/reporting.
• Excellent communication and interpersonal skills to build and maintain effective working relationships with cross-functional teams.
• Proficiency in using data management tools to generate listings for data review and provide these to study teams.

Skills Desired

Clinical Data Management, Data Architecture Development, Data Governance, Data Integration, Data Management, Data Profiling, Data Quality, Data Science, Data Strategies, Master Data, Waterfall Model