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<b>Head, Clinical Document Management Process</b>




East Hanover, New Jersey, United States

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.<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>The Head, Clinical Document Management Process (CDMP) group is accountable for implementing and embedding document management processes and standards aligned and harmonized across Novartis business units (across Global Drug Development (GDD), Global Medical Affairs (GMA), Novartis Institutes for Biomedical Research (NIBR) and Sandoz) enabling Novartis to meet its sponsor obligations on consistent, quality, readily accessible, inspection ready and available crucial documentation in the shape of a Trial Master File (TMF) for human subject research studies.<br><br>The Head, CDMP drives the tactical implementation of the Clinical Document Governance & Management (CDGM) strategy to meet immediate needs and evaluate future strategies to build on, ensuring Novartis is in a strong position to deliver Trial Master File (TMF) for all studies in a simple, consistent, balanced way in alignment with international regulatory expectations.<br><br><b>Your responsibilities include, but are not limited to</b>:<br>• Establishes and maintains Standard Operating Procedures, Business Practices and other types of written standards (e.g. specifications, guidelines, instructions) on harmonized way of generating, collecting, quality checking, approving, filing, reviewing, and archiving fit-for-purpose crucial documentation in compliance with Good Documentation Practices (GDocP) and ALCOA CCEA principles. Tracks process efficiency through metrics and spot checks, encouraging a continuous improvement mindset<br><br>• Establishes and maintains Forms, Templates and other types of written standards (e.g. checklists, user guides, process flow maps, best practices) to aid the consistent generation, collection, quality check, approval, filing, review, and archival of fit-for-purpose crucial documentation in compliance with Good Documentation Practices (GDocP) and ALCOA CCEA principles<br><br>• Establishes and embeds the TMF Reference Model governance model as the recognized Novartis backbone for crucial documents lists, taxonomy and metadata management in close collaboration with representatives of the line functions owning the documentation content<br><br>• Drives the creation of clear, effective and engaging Training Curricula for the TMF processes and their execution in collaboration with TM COE group and ensures the creation of fit-for-purpose role-based Training Curricula for TMF tasks/document management and archiving<br><br>• Continually scans and keeps sight of the evolving Regulatory landscape through proactive industry intelligence and encouraging an external network<br><br>• Provides Audit/Inspection support, maintains credibility by building trusted relationships with the internal QA functions and Health Authorities inspectors and by delivering commitments and Corrective and Preventive Action plans on time<br><br>• Establishes and maintains a sustainable User Support Model for answering process related inquiries in a timely, efficient and resolutive manner<br><br>• Sets, reviews and evaluate annual performance objectives for the CDMP group in alignment with company goals, establishes priorities and distribution of work, forecasts demand and resource needs and contributes to the CDGM budget cycles<br>[#video#{#400,300#}#/video#]