Clinical Document Migrations Manager
Clinical Document Migrations Manager
Posted on :
21-08-2025
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1 Vacancy
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Job Description
Job Description Summary
The Clinical Document Governance Management (CDGM) is responsible for the strategy and implementation of clinical document management (CDM) 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 CDM Business Migrations Manager position within the Clinical Document Governance and Management at Novartis could be the position for you.This role involves strategy planning and delivery of technical migrations to from and within Novartis enterprise-wide clinical electronic document management systems. Youll also get a chance to work alongside other Clinical Document and Governance Management groups and business line functions. Your 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
Job Description
Job Description:
The Clinical Document Governance Management (CDGM) is responsible for the strategy and implementation of clinical document management (CDM) systems processes and standards; as well as the operations of CDM services which include Trial Master File (TMF) management clinical submission preparedness record retention TMF integrations for BD&L deal archiving and enhancing Good Documentation Practice capability worldwide in Novartis. Additionally CDGM spearheads the transformation of TMF at Novartis by pioneering the adoption of revolutionary technologies processes and working methods.
We are seeking a knowledgeable and experienced Clinical Document Management - Business Migrations Manager to handle the strategy planning and delivery of technical migrations to from and within Novartis enterprise-wide clinical electronic document management systems. This role will be pivotal in implementing the Clinical Document Governance Management initiatives projects and process improvement activities.
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.
Requirements:
Advanced degree or a combination of Bachelors 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 of 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 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. Ability to communicate effectively at all levels.
Desired Skills:
Clinical document management technical migration Budget Management Clinical Trials Coaching Data Analysis Data Integrity Learning Design Life sciences Risk Monitoring Trends Analysis Veeva Vault TMF.
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 : to Diversity & Inclusion:
Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve.
Skills Desired
Budget Management Clinical Trials Negotiation Skills Process Improvement Project Planning Vendor Management Waterfall ModelRequired Experience:
Manager
Employment Type
Full-Time
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