Clinical Document Management Process User Support Team Lead

Location: #LI-Hybrid, #LI-Distance WorkerClinical 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.This role will be accountable for leading a team responsible for ensuring effective planning, delivery and oversight of user support and knowledge management activities in relation to clinical document management processes and systems across the Novartis organization,Key Responsibilities:• Lead a team delivering user support and knowledge management activities related to the delivery of capability and learning services to help drive adoption of Trial Master File (TMF) and good documentation practices across the business.• Identifies, plans and drives implementation of CDGM initiatives, projects and process improvement activities to improve clinical document management user support and knowledge management at Novartis.• Act as CDGM user support and knowledge management contact for key stakeholders, collaborating with them to improve clinical documentation process, systems and capabilities across the organization.• Delivers excellence in service delivery, including optimization and simplification in compliance with Novartis policies & regulatory requirements, responding in an agile way to new or evolving business priorities.• Provide robust oversight of 3rd party vendor activities including monitoring balanced performance against SLAs.Lead or give to multi-functional initiatives or projects, including defining and gaining approval for projects or initiatives, and ensuring work is achieved in line with agreed timeframes and budget.• Embeds a risk-based approach across the team and in service delivery, ensuring identification, evaluation and management of risks, including mitigation activities.Set priorities, handle schedules and develop robust resourcing model to support timely delivery of TMF services.• Support CDGM and business teams in preparation for and during audits, inspections and migration activities. Own CAPAs arising from inspections/audits ensuring they are closed out on time.• Leads team, recruits, retains, manages and develops associates through coaching and feedback, talent reviews and other available Novartis resources and tools, and champions a safe environment for team dialogue and growth. **The ideal location for this role is the East Hanover, NJ site but a distant working arrangement may be possible in certain states. Distant workers are responsible for the cost of home office expenses and periodic travel/lodging to the East Hanover, NJ site, as determined necessary by hiring manager. This position will require minimal travel as defined by the business (domestic and or international).