Principal Clinical Data Scientist

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 to oversee all aspects of data management, coding, CDD, and DAP for several studies or medium to large-sized projects. This role is crucial in ensuring that pharmaceutical drug development plans at Novartis Global Drug Development are executed efficiently with high-quality deliverables. The successful candidate will conceptualize and implement scalable training delivery models and platforms, follow and oversee Good Clinical Practices (GCP), and ensure consistency across assigned programs to aid efficiencies for submissions.

 

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, Data Governance, Data Integration, Data Management, Data Profiling, Data Quality, Data Science, Data Strategy, Master Data, Waterfall Model