Lead the implementation of CDGM initiatives to enhance the planning and execution of technical migrations.
Liaise with internal and external stakeholders to plan and execute technical 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 technical migration roadmap.
Serve as a Subject Matter Expert for training materials and tracking tools for eDMS technical 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.
Requirements
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 technical migrations of clinical documents, particularly eTMF, experiences in Veeva Vault related technical migrations will be a strong advantage
Deep knowledge of Agile working methodologies.
Strong influencing and presentation skills.
Ability to communicate effectively at all levels.
Benefits
Commitment to Diversity & Inclusion : Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
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