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Job Details


CDM Inspection, CAPA & Risk Oversight Manager (x3)



Full Time

On Site


East Hanover, New Jersey, United States

Job Description

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.
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.

Your responsibilities include, but are not limited to:
• Act as CDGM POC for Health Authority Inspection and internal audits - coordinating preparation, support and addressing findings, including identifying root causes of findings, creation of CAPAs and effectiveness checks, monitoring of CAPA execution to ensure deliverables are achieved in line with desired improvement and agreed timeframes.
• Identify and oversee implementation of Health Authority Inspection and internal audits from inspections/audits to improve clinical documentation process, systems and capabilities.
• Partner with network of CDGM Quality responsible persons (QARPs), business and QA stakeholders to ensure Quality Issues and Quality Events are identified, assessed, managed and resolved effectively in line with Novartis processes - with root causes assessed, and lessons lea applied to future ways of working.
• Member of cross-functional teams on business process, performance or system enhancement initiatives focused on improving inspection readiness and TMF Health.
• Partner with key risk management and QA stakeholders to ensure a robust risk management framework is in place for CDGM, aligned to Novartis risk management best practices.
• Support consistent identification, evaluation and tracking of CDGM service risks, including identification of risk mitigation owners and development of robust risk mitigation plans.
• Support development of CDGM staff capabilities in relation to inspection/audit support and to embed risk-based approaches into CDGM service delivery.
• Maintain an awareness of the external regulatory environment and Novartis processes for inspection/audit support, and risk management and apply those to CDGM ways of working.