About the role
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,
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, Data Strategy, Master Data, Waterfall ModelSkills & Tags
Aplyr's read
Novartis is a Swiss-based global healthcare leader, known for its focus on innovative medicines and commitment to addressing patient needs through diverse roles.
What's promising
- •Novartis invests heavily in research and development, driving innovation in pharmaceuticals.
- •The company offers a wide range of global career opportunities across various fields.
- •Strong focus on cutting-edge therapies, including gene therapy and AI-driven solutions.
What to watch
- •Regulatory challenges can impact the speed of drug approval and market entry.
- •High competition in the pharmaceutical industry requires constant innovation to maintain market position.
- •Complex organizational structure may slow decision-making processes.
Why Novartis
- •Novartis has a robust pipeline of innovative medicines, setting it apart in the healthcare sector.
- •The company emphasizes a diverse and inclusive workplace culture across its global operations.
- •Novartis is a leader in digital transformation within pharmaceuticals, integrating AI and data science.
Aplyr’s read is generated by AI from public sources. Was it useful?
About Novartis
Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide. It focuses on innovative medicines, generics, and eye care.
