Summary
About the Role
Major accountabilities:
- Your responsibilities include, but are not limited to:
- Design and implement the Novartis CDM Reference Model management framework partnering with key business and technology stakeholders to ensure effective controls of essential documents lists, taxonomy and metadata management across multiple systems and processes.
- Lead the CDM Reference Model governance board, providing structure and process around it, facilitating effective decision-making and arbitrating across subject matter experts in multiple disciplines, line functions, and business units, creating/owning document content.
- Drive platform interoperability through metadata standard strategy that can adapt with the changing Novartis technology landscape.
- Lead strategic planning and assessment efforts across business units to support continuous improvement and ongoing release management efforts of deployed technology.
- Develop and deliver strategies to increase the adoption and improvement in TMF health and document management across stakeholder groups through the effective implementation of Reference standards, and contribution to filing guidance, learning material and templates.
- Lead external benchmarking exercises and maintain external visibility and connections to stay at the forefront of classification and standards management.
- Provide support in preparation for audits/inspections, contributes to root cause analysis identification and creation/delivery of CAPAs in relation to Reference Model standards.
- Timely, efficient and quality execution of TMF related activities within budget and resources within 5% of cost overruns
- Reduction and management of TMF risk with effective strategic, contingency and risk mitigation plans
Minimum Requirements:
- Minimum of 7 years working in bio-pharmaceutical clinical research and development with specific experience in clinical operations processes and clinical systems data interoperability.
- In-depth knowledge of the TMF Reference Model, EDMS reference model, and other data governance standards.
- Demonstrated success in running cross functional initiatives, facilitating governance boards and/or leading matrixed teams.
- Strong influencing and presentation skills. Ability to communicate effectively at all levels.
- High organizational awareness, including experience working in multi-disciplinary teams, across cultures and geographies.
Good negotiation, problem solving and conflict resolution skills.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.
Accessibility & Reasonable Accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
