Senior Principal Clinical Data Scientist

Novartis India; Hyderabad; On-site; INR 1,800,000 - 3,200,000; Full time

Job summary

Novartis India is seeking a responsible Data Manager to oversee all data management, coding, CDD/DAP aspects across multiple studies. You will collaborate with stakeholders to ensure timely, high-quality deliverables that align with GCP and trial data standards.

You will lead audits, coordinate data managers, and implement scalable training delivery models for end-to-end data solutions.

Qualifications

• Proven experience in clinical data management and data governance.
• Ability to manage multiple tasks and projects.
• Cross-cultural experience in managing clinical data activities.
• Ability to resolve protocol issues impacting database design and analysis.

Responsibilities

• Lead functional data management activities for mid-to-large phase I–IV trials.
• Coordinate data managers internally and externally.
• Make data management decisions at study level.
• Ensure standardized data management processes across projects.
• Provide data management solutions and knowledge sharing.
• Lead training across platforms and therapeutic areas.
• Represent Data Operations in audits and inspections.

Skills

Clinical data management

Data architecture

Data governance

Data integration

Data profiling

Data quality

Data science

Data strategy

Master data

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 Developnment 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,

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 Developnment 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,

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.

Why Novartis:

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards:

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