Novartis
TMF Document Processing Oversight Manager
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Job Description
- Req#: 363913BR
TMF Document Processing Oversight Manager
Location – United Kingdom/Ireland
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.
Your responsibilities include but not are limited to:
• Delivery of high quality and timely document processing services (document import, indexing and technical QC) for a portfolio of internal studies.
• Responsible for document processing services being delivered to agreed timelines and quality targets, for an assigned portfolio of studies. Identifies and communicate processing risks/trends/patterns related to document processing and works with key stakeholders to define and implement pragmatic remediations.
• Executes vendor oversight plan, monitors service metrics and identifies opportunities for improvement to the operating model. Acts as point of escalation for issues.
• Serves as Subject Matter Expert on TMF training materials, formal and informal processes and tracking tools for TMF oversight activities in collaboration with CDM Process team and other key stakeholders
• Identify and implement improvements to processes to improve capability, capacity and quality of document processing services. May act as business lead for innovation projects to enhance document processing services.
• Supports the forecasting and tracking of document processing resource needs including proactive identification of resources to support activities for high-risk and priority projects, partnering with key stakeholders .
• Support the definition and refinement of the document management strategy for outsourced studies, including efficient document returns processes.
• Oversight of document import and indexing/classification for smooth and timely transfer of documents for in-licensed studies or from third-parties to Novartis eDMS.
Provide support in preparation for audits/inspections, contributes to root cause analysis identification and creation/delivery of CAPAs.
#GCO #CDGMAbout the company
At Novartis, we are reimagining medicine to improve and extend people’s lives. We are working hard to produce breakthroughs and address unmet needs for patients with devastating diseases, including genetic disorders and certain deadly cancers. Learn mo...
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