• Lead end-to-end planning and execution of clinical document migrations.
• Drive CDGM initiatives to improve migration strategy, governance, and operational execution
• Partner with internal and external stakeholders to plan and execute migrations, ensuring alignment with Novartis business, compliance, and operational requirements.
• Collaborate with stakeholders to identify and agree on migration business requirements, understand source and target system capabilities and develop a future migration roadmap.
• Serve as a Subject Matter Expert for training materials and tracking tools for electronic document management system (eDMS) migration activities.
• Manage activities related to migration-related Incident Management, Change Management, and ongoing operations of the eDMS.
• Support the forecasting of internal resource allocations and vendor-provided activities as part of eDMS migration roadmap management.
• Execute the vendor oversight plan, monitor service metrics, and identify opportunities for improvement.
• Provide support for inspections/audits, contribute to root cause analysis and creation/delivery of CAPAs.

• Degree in information or life sciences/healthcare and extensive experience in Pharmaceuticals, Life sciences, and Clinical Research
• Proven track record in leading of clinical document management, TMF and/or records & information management, with a deep knowledge of Trial Master File (TMF) reference model and experience in Electronic Document Management systems, specifically in Clinical and Regulatory (e.g. Veeva Clinical vault, RIM, Documentum D2LS)
• Solid portfolio of full-scale migrations of clinical documents, particularly eTMF, experiences in Veeva Vault related migrations will be a strong advantage
• Deep knowledge of Agile working methodologies.
• Excellent communication, influencing, and stakeholder management skills across global teams

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