Novartis is unable to offer relocation support for this role.

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 migrations to, from, and within Novartis enterprise-wide clinical electronic document management systems. This role offers a unique opportunity to influence enterprise-wide digital transformation, working at the intersection of business and technology to drive migration initiatives with an objective of overall electronic Trial Master File (eTMF) system consolidation, TMF integration for Business Development & Licensing (BD&L;) deals and TMF Document transfers ensuring compliance in collaboration with other CDGM groups, business and Information Technology (IT) departments. If you are passionate about driving change and delivering solutions that ultimately support bringing life-changing therapies to patients, this is your opportunity to make a meaningful impact.The position is part of CGDM team and reports directly to Clinical Document Management: Lead end-to-end planning and execution of clinical document migrations.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.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 ResearchProven 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 advantageDeep knowledge of Agile working methodologies.Excellent communication, influencing, and stakeholder management skills across integral teamsBenefits & Rewards At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen. In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs.

In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave. Read our brochure to learn more about our global total rewards offering: Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable.

Skills DesiredBudget Management, Clinical Trials, Process Improvements, Project Planning, Vendor Management, Waterfall ModelSummaryLocation: Full time

📌 Manager, Clinical Trial Management (Cataluña)
🏢 Novartis
📍 Cataluña