Principal Clinical Data Scientist

Novartis; Mumbai City; Vor Ort; INR 4.000.000 - 6.500.000; Vollzeit

Zusammenfassung

Novartis is seeking a Principal Data Scientist to oversee data management activities for clinical trials, ensuring high-quality, timely deliverables in alignment with our Quality Statement. You will collaborate with Clinical Trial Teams and stakeholders to drive data strategy, governance, and standardization across programs.

The role requires leading teams, coordinating internal and external Data Managers, and guiding data management decisions to optimize study design and analyses.

Qualifikationen

• Proven experience across clinical data management, data architecture, governance, integration, profiling, quality, data science, data strategy and master data.
• Strong project management skills with ability to handle multiple tasks and projects simultaneously.
• Cross-cultural experience and 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 collaborate with cross-functional teams.
• Proficiency in using data management tools to generate listings for data review and share with study teams.

Aufgaben

• 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.

Kenntnisse

Clinical data management

Data architecture

Data governance

Data integration

Data profiling

Data quality

Data science

Data strategy

Master data

Waterfall model

Jobbeschreibung

Job Description Summary

The Principal Data Scientist is responsible and accountable for managing all Data Management activities using advanced data management tool and techniques with respect to cost, quality and timelines for all assigned projects/trials within a Clinical Program. The position is a key collaborator and strategic partner with stakeholders ensuring that data management activities for the clinical trials are executed efficiently with timely and high quality deliverables (in alignment with the Novartis Clinical Data Quality Statement). Provide active and effective communication to Clinical Trial Teams and other stakeholder groups

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, Master Data, Waterfall Model