Clinical Document Migrations Manager

Role Overview: You will be responsible for leading the strategy and implementation of clinical document management (CDM) systems, processes, and standards as the Clinical Document Management - Business Migrations Manager at Novartis. Your role will involve handling technical migrations to, from, and within Novartis enterprise-wide clinical electronic document management systems. Key Responsibilities: - Lead the implementation of CDGM initiatives to enhance the planning and execution of technical migrations. - Collaborate with internal and external stakeholders to plan and execute technical migrations while ensuring alignment with Novartis business, compliance, and operational requirements. - Identify migration business requirements, understand source and target system capabilities, and develop a future technical migration roadmap in collaboration with stakeholders. - Act 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 internal resource allocations forecasting and vendor-provided activities as part of eDMS migration roadmap management. - Execute the vendor oversight plan, monitor service metrics, and identify improvement opportunities. - Provide support for inspections/audits, contribute to root cause analysis, and creation/delivery of CAPAs. Qualifications Required: - Advanced degree or a combination of Bachelor's degree in information or life sciences/healthcare and relevant industry experience. - Minimum of 6 years working in Pharmaceuticals, Life sciences, and Clinical Research with specific experience in leading clinical document management, TMF, and/or records & information management technical migration. - Minimum of 5 years of full-scale technical migrations of clinical documents, particularly eTMF. - At least 2 major experiences in Veeva Vault related technical migrations. - Prior experience and knowledge of the Trial Master File (TMF) reference model. - Prior experience in Electronic Document Management systems, specifically in Clinical and Regulatory (e.g., Veeva Clinical vault, RIM, Documentum D2LS). - Deep knowledge of Agile working methodologies. - Strong influencing and presentation skills with the ability to communicate effectively at all levels. Additional Details of the Company: Novartis is committed to building an outstanding, inclusive work environment and diverse teams that are representative of the patients and communities they serve. Note: Benefits, rewards, and accommodation details have been omitted from the Job Description.,