CDM Migration Business Lead

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 Migration Business Lead is responsible for effective planning and delivery of migrations to and from of Novartis enterprise-wide clinical electronic document management systems (eDMS) aligned to Novartis business needs, partnering with technical vendors, internal IT and business stakeholders. Drives implementation of CDGM initiatives, projects and process improvement activities to enhance the planning and execution of migrations to and from enterprise clinical eDMS at Novartis. Act as CDGM point of contact for partnering with CDGM, IT (internal and external) and business stakeholders to plan and execute migrations to and from eDMS, in line with Novartis business, compliance and operational requirements. Partner with CDGM and business stakeholders, especially those planning in-licensing and out-licensing activities to identify and agree migration business requirements, understand source and target system capabilities and develop/maintain a future migration roadmap. Contribute to activities to ensure efficient processes & integrations of systems with eDMS based on strong understanding of Novartis enterprise systems landscape and in line with compliance and business priorities. Serves as Subject Matter Expert for training materials, formal and informal processes and tracking tools for eDMS migration activities, in collaboration with CDM Process team and other key stakeholders Plan and contribute to agile working methodologies being applied during development cycles to prepare for migration and during post migration hyper care period. Owner or Contributor of activities related to migration related Incident Management, Change Management and ongoing operations of the eDMS. Support forecasting of internal resource allocations and vendor provided activities as part of eDMS migration roadmap management. Executes vendor oversight plan, monitors service metrics and identifies opportunities for improvement to the operating model in relation to migration. Acts as point of escalation for issues. Provides support for inspections/audits, contributes to root cause analysis identification and creation/delivery of CAPAs.