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Job ID 308795BR Position Title Director Clinical Data Standards Apply to Job
1050! The number of Novartis associates that use our data standards, tools and solutions every day as we relentlessly seek to cross the bridge that transforms great science to great medicines.
Supports Head CDS in setting the standards and automation strategy across Novartis. Run a global team(s) responsible for executing data standards / automation objectives across DO. Responsible for ensuring quality, scalable, reusable, (CDISC and regulatory) compliant data standards and technologies are visibly deployed across GDO in close collaboration with external industry peers and internal partners delivering stellar customer focus. Responsible for planning and overseeing KPIs/metrics, frameworks, policies, business rules and processes for development, maintenance, deployment. Responsible to ensure Novartis fulfills a return on investment across the standards and automation landscape.
• Manage a global team(s) of Clinical Data Standards Specialists providing operational, technical and strategic management and development of teams.
• Accountable for all aspects of Clinical Data Standards delivery within assigned field including the strategy and planning to ensure the successful development and maintenance of end-to-end s data and reporting standards in one or more fields of data acquisition and tabulation, analysis and reporting and/or regulatory data submission across multiple disease/therapeutic areas and drug development phases.
• In collaboration with stakeholder and partner functions across and outside of GDO, accountable for driving standards implementation across the organization and defines and supervises KPIs/metrics, strategies, frameworks, policies, business rules and processes for development, maintenance, deployment and adoption with a strong focus on scientific and regulatory needs.
• Lead the technical review and assessment of industry and regulatory standards and technologies supporting regular gap/impact analysis and implementation of action plans where needed.
• Act as an experienced consultant /SME providing Clinical Data Standards input to all relevant areas including; electronic data capture/database programming, edit check programming, report programming, electronic data loads, IVR technology, electronic patient reported outcomes, metadata management and/or other clinical data management or analysis data and TFL-related systems.
• Support the development and maintenance of a robust, industry recognized Data Operations organization:
• May also represent at internal and external decision boards and deputize for Head CDS as required.
• BA/BS/MS or equivalent experience in mathematics, statistics, computer science, health sciences or related field.
• Fluent English (oral and written).
• Strong leadership, collaboration and organizational skills with confirmed ability to successfully lead numerous, simultaneous submissions/projects/trials across multiple Therapeutic Areas and meet deadlines
• Consistent record to anticipate challenges and risks and proactively implement solutions
• Excellent analytical, problem solving and time leadership skills
• Ability to work under pressure demonstrating agility through effective and innovative leadership
• Excellent social skills and consistent track record to operate effectively in a complex global environment. Ability to influence and communicate across functions and to external partners
• Proven record to build effective teams that deliver towards the goals of the Data Operations organization
• At least 10 years broad experience in clinical development, preferably with end-to-end metadata or MDR experience.
Why consider Novartis?
799 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
Imagine what you could do at Novartis! Division Global Drug Development Business Unit GDO GDD Location Switzerland Site Basel Company/Legal Entity Novartis Pharma AG Functional Area Research & Development Job Type Full Time Employment Type Regular Shift Work No
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