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 Required
- Proven experience in clinical data management
- Experience in data architecture development
- Experience in data governance and master data management
- Experience in data integration, data profiling, and data quality
- Experience in data science and data strategy
- Strong project management skills with ability to manage multiple projects
- Cross-cultural experience managing clinical data management activities
- Ability to recognize and resolve protocol issues impacting database design, validation, and reporting
- Excellent communication and interpersonal skills for cross-functional collaboration
- Proficiency using data management tools to generate listings for data review
- Knowledge and application of Good Clinical Practices (GCP) and data-handling procedures
Novartis Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Novartis and has not been reviewed or approved by Novartis.
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Healthcare Strength — Pay and benefits are described as a strong overall package, supported by medical, dental, and vision insurance alongside FSAs/HSAs and disability and life coverage. Mental-health support is reinforced through an employee assistance program with psychological support and a network of mental health first aiders.
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Retirement Support — Retirement support is positioned as a standout element, with an automatic company contribution plus dollar-for-dollar matching in the 401(k). Additional retirement funding is described through an age-based defined contribution program and access to an employee share purchase plan discount.
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Parental & Family Support — Family-related benefits are framed as robust, including a global minimum of paid parental leave for new parents following birth or adoption. Added supports include domestic partner coverage, dependent-care resources, and benefits such as adoption assistance and child/elder care options.
Novartis Insights
What We Do
Novartis is an innovative medicines company. Every day, working to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.
