TMF Expert Archivist
Ensure efficient and appropriate management of GxP relevant archiving processes in compliance with internal and external guidelines by leading process governance and inspection readiness initiatives and coordinating archivist activities across global GxP archives.
As part of the document management Archivist team, you will be mainly driving the “Retention project” and will have the responsibility to create and lead the implementation of the new retention schedule policy with adequate destruction processes for the Paper TMF Documents, which are archived in multiple locations including an off-site Archiving vendor, as well as for Electronic TMF Records, retained in our main electronic Document Management Systems and the related TMF Sub-Systems.
This project will require project management skills, organization and motivation to drive it to a successful outcome.
Ensure quality, inspection-readiness, timeliness and efficiency of facility management and document processing standards for local and global archival facilities and guide peer archivists on the following tasks in accordance with HA guidelines, Good Clinical Practices, SOPs, and IGM requirements:
• Manage archiving of TMF/PSF/ISF and other regulatory records with long-term retention periods in cooperation with business representatives
• Ensure oversight and control over archived GxP essential documents appropriately according to GxP and applicable SOPs
• Manage archive services provided by external partners, including but not limited to site management and off-site archival (status updates, demand management, ongoing quality control, invoice management)
• Manage and globally coordinate creation and/or update of applicable SOPs, Guidance Documents, templates etc., as applicable
• Manage and globally coordinate transition of knowledge about adherence to archiving regulations into the respective line organizations, i.e. ensure training and support activities for business functions
• Manage support processes for document management related requests from business functions, which may include Legal requests, In/Out Licensing projects, and audits/inspections
• Continuously oversee and identify rooms for improvement for global document management processes, in particular in the areas of archiving and TMF management. Lead and coordinate global implementation activities as applicable
• Promote best documentation practice to line functions to ensure that documents created/generated in the course of clinical research are managed and archived in accordance with GCP guidelines and applicable SOPs
• May support appropriate and accurate document creation and document lifecycle management in the Document Management System (DMS)
• Lead and coordinate implementation activities for electronic archiving processes in a Next Generation DMS. Ensure change management and training needs for archivists are met in liaison with implantation project support functions (e.g. training team)
• May own and maintain electronic systems for tracking archived records
• Support audits and inspections by acting as first line contact for auditor and inspector inquiries
• Liaise and cooperate with stakeholder functions within GDD
Key Performance Indicators:
• Inspection-readiness of archival facilities and archiving processes - no critical audit or inspection findings
• Timely and high-quality provision of submission documents
• Consistent and efficient use of archiving processes in line organizations
• Minimum 6 years’ relevant clinical research/pharmaceutical industry experiences
• Minimum 4 years’ experience;
o handling GxP-relevant documents
o in document management systems and excellent understanding of system structures and generic document management functionality
o in monitoring and quality control of deliverables provided by external vendors
• Experience with stakeholder management in a matrix organization.
• Advanced knowledge of clinical documentation and reporting
• Knowledge of applicable research and regulatory environments, i.e. International Conference on Harmonization (ICH), Good Clinical Practice (GCP)
• Good understanding of technical processes and PC environment including Microsoft suite of products
• Advanced ability to work both independently and in matrix team setting
• Ability to handle multiple tasks and projects within defined timelines and balance competing priorities
• Excellent communication, organization and tracking skills
• Bachelor’s degree in life science/healthcare is required
• Fluent written and oral English
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.
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