CDM Knowledge Manager
- East Hanover, New Jersey, United States
- Closing date
- Apr 1, 2023
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 capability, learning and knowledge management activities related to the delivery of CDGM services and the adoption of TMF (Trial Master Files) 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.
Your responsibilities include, but are not limited to:
• Accountable for knowledge management activities related to clinical document management processes, 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 implement effective, fit for purpose capability development, learning and knowledge management deliverables to users of TMF and CDGM services across the business.
• Partner with key stakeholders across the business to understand learning and knowledge management needs and proactively identify/implement solutions to meet those needs.
• Create and manage metrics/KPIs and dashboards relating to CDGM learning, capability and knowledge management activities and facilitate discussions with CDGM LT and others relating to trends and issues.
• Partner with service providers and internal stakeholders to ensure 3rd party partners are aware of and delivering their services aligned with CDGM capability, learning and knowledge management requirements.
• Partner with learning, capability and knowledge management groups across Novartis to ensure CDGM are aligned with wider efforts, and to keep aware and leverage best practices and new developments.
• Serve as Subject Matter Expert on TMF learning, formal and informal processes and tracking tools relating to learning, capability development and knowledge management.
• Support the development and delivery of strategies to increase the adoption and improvement in TMF health and document management across stakeholder groups.
• Provide support in preparation for audits/inspections, contributes to root cause analysis identification and creation/delivery of CAPAs.
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.
The role can be based in either in Ireland, UK, Switzerland, or US (Hanover, NJ). Our selection process will prioritize associates whose roles may be changing or may be impacted.
Should you be interested in a non-US listed location, please refer to requisition 363927BR to apply. Please note relocation will not be provided.
What you’ll bring to the role:
• 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.
736 million lives were touched by Novartis medicines in 2022, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
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.
The pay range for this position at commencement of employment is expected to be between $124,000 and $186,000/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.
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
At Novartis, we are reimagining medicine.
Our purpose is to reimagine medicine to improve and extend people's lives. We use innovative science and technology to address some of society's most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible.
Novartis has one of the industry’s most competitive pipelines. Many of these projects, which include new molecular entities as well as additional indications and different formulations for marketed products, are for medicines that could significantly advance treatment standards for patients worldwide.
We have entered an exciting era in health and biomedical innovation. Powered by our incredible colleagues, supported by our flexible-hybrid working model, new AI powered learning, personal growth and career platform and a refreshed commitment to diversity, equity & inclusion, we are well-poised to help lead this transformative moment for our industry and for ourselves. Join Us!
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