Clinical Document Management Technology Team Lead

  • Dublin
  • Novartis
Location: Please note that this position can be based in the UK as a home worker or Dublin, Ireland as a Hybrid position.Clinical Document Governance Management (CDGM) is accountable for strategy and delivery of clinical document management (CDM) systems, processes, standards and operations of CDM services (including Trial Master File management (TMF), clinical submission readiness, record retention and archiving, Good Documentation Practice capability build) across Novartis globally. In addition, CDGM is driving the transformation of TMF at Novartis, through the introduction and adoption of new technologies, processes and ways of working.The CDM Technology Team Lead is accountable for effective planning, delivery and operational oversight of Clinical Document Management and Interfacing systems used for management of clinical documents required for regulatory submissions to ensure rapid, accurate and timely submissions to health authorities.Your responsibilities include, but are not limited to:Drives CDGM pivotal initiatives related to implementation, operations and business administrative support for enterprise document management systems (eDMS) to manage Clinical Documents originating from Clinical Trials.Partners effectively with multi-functional stakeholders (e.g., Regulatory Affairs, Quality) to ensure eDMS are managed, updated and operated in agreed strategy and timelines to ensure seamless availabilityLead and be active contributor and owner of activities related to Incident Management, Change Management and ongoing operations of the eDMSLead internal resource allocations and oversight for vendors delivering eDMS servicesLead a high performing Business Administration team supporting 24/7 operations to ensure continuous and timely availability of CDM content for global business usersRecruits, retains, manages and develops associates through coaching and feedback, talent reviews, and managing performance.Key member of cross-functional teams on business process, performance or system enhancement initiatives focused on Document Management systems used by Clinical and Regulatory Affairs teams, as required & support CDGM and business teams in preparation for and during audits & inspections.