Senior Principal Clinical Data Scientist

Novartis India; Telangana; Vor Ort; INR 1.800.000 - 2.400.000; Vollzeit

Zusammenfassung

Novartis India is seeking a senior data management professional to oversee data management, coding, CDD and DAP aspects for multiple studies within the Global Drug Development organization. You will collaborate with stakeholders to ensure timely, high-quality deliverables, and design scalable training and data-handling platforms in line with GCP guidelines.

You will lead cross-functional teams, drive standardization across programs, and represent Data Operations in audits, supporting submissions

Qualifikationen

• Proven experience in clinical data management, data architecture and governance.
• Experience with data integration, profiling and quality initiatives.
• Strong project management skills across multiple tasks and projects.

Aufgaben

• Lead and manage data management activities for phase I–IV studies within GDO.
• Coordinate internal and external data managers and drive standardized processes.
• Develop data management strategies, training, and knowledge sharing.
• Represent DO in audits and inspections and ensure timely deliverables.

Kenntnisse

Clinical data management

Data governance

Data integration

Project management

Cross-cultural collaboration

Jobbeschreibung

• 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,

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,

About The Role

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:

Learn about all the ways we’ll help you thrive personally and professionally.

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