Director - Clinical Data Standards
- Hyderabad, India
Supports Head CDS in setting the standards and automation strategy across Novartis. Manage 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 transparently deployed across GDO in close collaboration with external industry peers and internal stakeholders 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 ROI across the standards and automation landscape.
Your responsibilities include, but are not limited to
• 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 discipline 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 disciplines 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 monitor KPIs/metrics, strategies, frameworks, policies, business rules and processes for development, maintenance, deployment and adoption with a solid 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 expert 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 high performing, industry recognized Data Operations organization:
• May also represent at internal and external decision boards and deputise for Head CDS as required.
• BA/BS/MS or equivalent experience in mathematics, statistics, computer science, health sciences or related field with At least 15 years broad experience in clinical data standards preferably with end to end metadata or MDR experience. Exposure to CDISC standards- CDASH, SDTM, ADaM, Terminology.
• Strong leadership, collaboration and organizational skills with proven ability to successfully manage numerous, simultaneous submissions/projects/trials across multiple Therapeutic Areas and meet deadlines
• Proven ability to anticipate challenges and risks and proactively implement solutions.
• Ability to work under pressure demonstrating agility through effective and innovative leadership
• Excellent analytical, problem solving and time management skills. Excellent interpersonal skills and proven ability to operate effectively in a complex global environment. Ability to influence and communicate across functions and to external stakeholders
• Excellent organizational planning and project management skills in order to maximize resource efficiency
• Proven associate development skills. Proven ability to build effective teams that deliver towards the goals of the Data Operations organization
Why consider Novartis?
799 million. That's how many lives our products touched in 2019. 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!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Back to top