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CDM Reference Model Manager




East Hanover, New Jersey, United States

100,000 and more!<br>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.<br>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.<br><br>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.<br> <br>Drives implementation of CDGM initiatives, projects, and process improvement activities to enhance clinical document management systems, processes, and standards at Novartis.<br><br>The role can be based in either Ireland, the United Kingdom or East Hanover, NJ USA. Should you be interested in a non-US listed location, please refer to requisition 363916BR to apply. Please note relocation will not be provided. <br><br>Our selection process will prioritize associates whose roles may be changing or may be impacted.<br><br>Major Accountabilities:<br><br>· Accountable for developing, implementing and maintaining TMF Reference Model governance partnering with key business and technology stakeholders.<br>· Drives implementation of CDGM initiatives, projects, and process improvement activities to enhance clinical document management systems, processes, and standards at Novartis.<br>· 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.<br>· 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.<br>· 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.<br>· Facilitate discussions with CDGM LT and others relating to trends and issues in processes and standards.<br>· 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.<br>· Serves as Subject Matter Expert on TMF formal and informal processes and TMF Reference Model management in collaboration with key stakeholders <br>· 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 <br>· Act as CDGM point of contact for other projects and initiatives, to ensure engagement and involvement of CDGM as needed.<br><br>#GCO<br>#CDGM<br><br>[#video# {#400,300#}#/video#]