Principal Clinical Data Scientist

Role overview

Principal Clinical Data Scientist at Novartis

Lead functional activities for medium to large-sized projects in phase I to IV clinical studies within the Novartis Global Development Organization.

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.

Responsibilities

• Ensure consistency across assigned program to aid efficiencies for submissionsParticipates in the review of clinical research protocols, reports and statistical analysis plans.
• 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.

Employment details

• Location: Hyderabad (Office) [India]

Additional role details

• 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.
• 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.
• Leads quality deliverables across platforms.
• Develops simple and reproducible strategies to ensure quality deliverables,