Job Description Summary
Location: Dublin Irland / London UK
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 youll 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.
#LiHybrid
Job Description
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 : 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
Required Experience:
Manager
Job Description SummaryLocation: Dublin Irland / London UKAre 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 ...
Job Description Summary
Location: Dublin Irland / London UK
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 youll 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.
#LiHybrid
Job Description
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 : 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
Required Experience:
Manager
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