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CDM Process User Support 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 delivering user support related to clinical document management processes, 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 in Ireland, the United Kingdom, Switzerland, or East Hanover, NJ USA. Should you be interested in a non-US listed location, please refer to requisition 363943BR 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>· Support the development and delivery of fit for purpose end user support in relation to CDGM / TMF processes to Novartis business groups.<br>· Partner with stakeholders across the business to understand user needs and root causes of issues in relation to TMF and CDGM service delivery and proactively identify/implement improvements to end user support activities.<br>· Support for management of metrics/KPIs and dashboards relating to CDGM end user support and conduct data analysis to identify trends and issues.<br>· Serves as Subject Matter Expert on TMF training materials, formal and informal processes and tracking tools relating to end user support. <br>· Partner with service providers and internal stakeholders to ensure end user support provided by 3rd party partners is aligned with CDGM requirements, and embed assessment of end user support into oversight of third-party service performance.<br>· Support activities to increase CDGM staff capabilities in relation to end user support, and embed user-centric approaches into CDGM service delivery.<br>· Provide support in preparation for audits/inspections, contributes to root cause analysis identification and creation/delivery of CAPAs<br>· Act as CDGM point of contact for other projects and initiatives, to ensure engagement and involvement of CDGM as needed.<br><br>[#video#{#400,300#}#/video#]