CDM Process & Standards Manager (Multiple positions)

Job Description

100,000 and more! That’s how many patients are treated in our studies. And every year, 3 million documents are uploaded in the electronic Trial Master Files to preserve the story of the study and ensure innovative medicines can reach even more patients worldwide.
But in this world of digital and technological transformation, we must also continue to evolve our approaches to clinical document management and unleash the power of information from this expanding universe of data.

Accountable for developing and implementing processes & standards and TMF (Trial Master File) Reference Model governance related to the delivery of CDGM services and the adoption of TMF and good documentation practices across the business.

Drives implementation of CDGM initiatives, projects, and process improvement activities to enhance clinical document management systems, processes, and standards at Novartis.

The role can be based in either Ireland, the United Kingdom, India or East Hanover, NJ USA. Should you be interested in a non-US listed location, please refer to requisition 363935BR to apply. Please note relocation will not be provided.

Our selection process will prioritize associates whose roles may be changing or may be impacted.

Your responsibilities include, but are not limited to:

• Accountable for developing and implementing processes & standards related to the delivery of CDGM services and the adoption of TMF and good documentation practices across the business.
• Drives implementation of CDGM initiatives, projects, and process improvement activities to enhance clinical document management systems, processes, and standards at Novartis.
• Develop and maintain content related to TMF and document management standard operating procedures, working practices, guidelines, templates and other policy written standards to support inspection readiness in alignment with ALCOA CCEA principles and good documentation practices, partnering with key stakeholders across the business.
• Support the TMF Reference Model governance board providing fact-based subject matter expertise on essential documents lists, taxonomy and metadata management in close partnership with CDM Technology and line function communities owning the content.
• Support the development and delivery of strategies to increase the adoption and improvement in TMF health and document management across stakeholder groups, providing clear and quality content for the creation of TMF/document management learning curricula.
• Facilitate discussions with CDGM LT and others relating to trends and issues in processes and standards.
• Partner with service providers and internal stakeholders to develop fit for purpose written standards for 3rd party partners and embed their use as part of robust oversight of third-party service performance.
• Serves as Subject Matter Expert on TMF formal and informal processes and TMF Reference Model management in collaboration with key stakeholders
• Provide support in preparation for audits/inspections, contributes to root cause analysis identification and creation/delivery of CAPAs in relation to TMF Processes and Reference Model
• Act as CDGM point of contact for other projects and initiatives, to ensure engagement and involvement of CDGM as needed.

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Diversity & Inclusion / EEO

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.

Minimum Requirements

What you’ll bring to the role:

• Bachelor’s degree or equivalent and relevant industry experience
• English fluency (written, oral) required
• Minimum of 5 years working in clinical research and development in the pharmaceutical industry (and/or Contract Research Organizations) with specific experience in clinical documentation and/or records & information management.
• Demonstrated success in planning and executing cross functional projects.
• 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; experience establishing trusted relationships with internal and external stakeholders.

Why consider Novartis?
736 million. That’s how many lives our products touched in 2022. 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.

Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

The pay range for this position at commencement of employment is expected to be between $151,200 and $226,800/year; however, while salary ranges are effective from 1/1/23 through 12/31/23, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability 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.

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

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