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Job Description
Job Summary
Manage clinical document governance and migrations to ensure seamless operations of clinical electronic document management systems across Novartis globally.
About the Role
The Clinical Document Management - Business Migrations Manager is responsible for planning and delivering migrations to and from Novartis enterprise-wide clinical electronic document management systems.
- Drive implementation of clinical document governance initiatives, projects, and process improvement activities to enhance migration planning and execution.
- Partner with technical vendors, internal IT, and business stakeholders to plan and execute migrations to and from enterprise clinical e DMS.
- Act as point of contact for partnering with CDGM, IT, and business stakeholders to plan and execute migrations to and from e DMS.
- Contribute to activities to ensure efficient processes & integrations of systems with e DMS based on strong understanding of Novartis enterprise systems landscape.
- Serve as Subject Matter Expert for training materials, formal and informal processes, and tracking tools for e DMS migration activities.
- Plan and contribute to agile working methodologies being applied during development cycles to prepare for migration and during post-migration hyper care period.
- Owner or Contributor of activities related to migration-related Incident Management, Change Management, and ongoing operations of the e DMS.
- Support forecasting of internal resource allocations and vendor-provided activities as part of e DMS migration roadmap management.
- Execute vendor oversight plan, monitors service metrics, and identifies opportunities for improvement to the operating model in relation to migration.
- Act as point of escalation for issues.
- Provide support for inspections/audits, contribute to root cause analysis identification, and creation/delivery of CAPAs.
Requirements
- Advanced degree or combination of Bachelor's degree in information or life-sciences/healthcare and relevant industry experience.
- Minimum of 6 years working in Pharmaceuticals, Lifesciences, and Clinical Research with specific experience in contributing and leading clinical document management, TMF, and/or records & information management.
- Minimum of 5 years of full-scale migrations.
- Minimum 2 medium to major Veeva-related hands-on and provable experience in leading and planning migrations.
- Prior experience in Electronic Document Management systems, specifically in Clinical and Regulatory highly desired.
- Business relevant technical and working experience of e DMS systems like Veeva Clinical vault, RIM, Documentum D2 LS or similar.
- Knowledge of industrywide Electronic and Clinical Document Management systems and features.
- Deep knowledge of Agile way of working with cross-functional teams for releases.
- Strong influencing and presentation skills.
- Ability to communicate effectively at all levels.
About Novartis
Novartis is a global healthcare company that is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.