Summary
Are you passionate about technical migrations of clinical documents ? Are you seeking innovative opportunities to apply your expertise across a large, diverse clinical trial migrations and BD&L TMF integration projects? If so, then the Clinical Document Migrations Manager position within the Clinical Document Governance and Management (CDGM) team at Novartis could be the position for you.
The Clinical Document Governance Management (CDGM) is responsible for the strategy and implementation of clinical document management (CDM). As Clinical Document Migrations Manager you'll take on strategy, planning, and delivery of technical migrations to, from, and within Novartis enterprise-wide clinical electronic document management systems. our task will be to drive migration initiatives aimed at both business and technical aspects of migration activities with an objective of overall eTMF system consolidation and TMF integration for BD&L deals, in collaboration with other CDGM groups, business and IT departments.
The position is part of CGDM team and reports directly to Clinical Document Management: Migration Team Lead.
#Li-Hybrid
This is a hybrid role and can be based in London or Dublin offices. The expectation is to be in the office 12 days/month
About the Role
Key Responsibilities:
- 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.
Essential 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.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting, and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? : https://www.novartis.com/about/strategy/people-and-culture
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.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
