Job Description Summary

This thought leader will establish strategic, best-in-class reference model standards across the enterprise. This includes design and implementation of a governance framework to maintain alignment of business units, system and functional strategies and priorities, by communicating the standards to all stakeholders and fostering feedback and engagement to continuously improve.

Job Description

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.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. 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.

Accessibility and 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 in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com 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.

https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings

Salary Range

$144,000.00 - $216,000.00

Skills Desired

Budget Management, Clinical Trials, Negotiation Skills, People Management, Process Improvement, Project Planning, Vendor Management, Waterfall Project Management