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The Senior Manager, Trial Master File (TMF) Operations is a key role within the Global Clinical Operations function. The Sr. Manager is responsible for TMF business operations and oversight of Ultragenyx’s (UGX) clinical portfolio, ensuring that clinical study records are maintained according to industry best practices and in adherence with applicable standard operating procedures (SOPs), Good Clinical Practice (GCP), International Council for Harmonization (ICH) E6(R2), and ALCOA+ standards and requirements. The Sr. Manager will oversee and support the activities of the TMF Operations team and work in collaboration with internal teams and external vendors to successfully lead key TMF initiatives, support TMF inspection readiness activities, evaluate and implement system capabilities, and promote a culture of TMF excellence.

Work Model: 

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

• Provide direct oversight, leadership, and delegation for routine deliverables of the TMF Operations team including recruitment and performance management activities
• Oversee TMF Operations activities and tasks that support the set-up, maintenance, submission, review, transfer, close-out and archival of study TMFs
• Support the development, maintenance, review and update of TMF Operations policies, standards, processes, work-instructions (WIs), and associated standardized tools, templates, and resources to ensure consistency and compliance across clinical programs and study teams
• Initiate and work collaboratively with internal teams and external vendors to author, review, and update study-specific TMF Plans and TMF indices utilizing standardized template language and content
• Track, manage, and schedule TMF periodic and final reviews in accordance with established TMF Plans and ensure Quality Issues (QIs) and/or gaps are appropriately addressed and resolved by the internal study team, external CRO, and/or third-party vendor(s), as required
• Collaborate cross-functionally to develop and implement training to internal teams, external vendors, and organizational stakeholders on Veeva Vault eTMF system functionality and processes associated with TMF management, review, and oversight
• Collaborate with Clinical Systems to assess Veeva Vault eTMF system release and new feature functionality for future implementation; utilize technical understanding of system configuration and security, system roles and privileges, workflows, reporting, and metrics functionality (e.g., milestones and EDLs) to provide required content and information for change management and training implementation
• Support Inspection Readiness (IR) initiatives and serve as subject matter expert (SME) to facilitate storyboard development, CAPA response and resolution, and guidance for industry best practices and standards to Study Teams and Clinical Quality Assurance
• Routinely attend and participate in Global and cross-functional meetings to provide TMF health and event awareness, oversight activities, and TMF metrics and trend reporting
• Coordinate and perform TMF final transfer activities for the receipt, review, acceptance, and archival of TMF final transfers from CROs and external vendors; including mechanisms for hybrid, paper, and electronic TMF scenarios and requirements

Requirements:

• Bachelor’s degree or equivalent (scientific or healthcare discipline preferred) with a minimum of 5 years of direct experience in TMF business operations and systems management is required (e.g., Veeva Vault eTMF, Wingspan, Documentum). Previous clinical trial and Pharmaceutical Sponsor SME experience desirable.
• Mastery and applicability of Good Clinical Practices (GCPs), International Conference for Harmonization (ICH) Standards, MHRA-EMA guidance, and Regulatory Authority Requirements for clinical trials.
• Expert knowledge and participation in internal/external audit and regulatory inspections (e.g., FDA, PMDA, EMA, MHRA, and various Regulatory Authorities) with a demonstrated ability to support inspection readiness activities (e.g., storyboarding, audit/inspection response/resolution, and CAPA requirements)
• Demonstrated ability to oversee, lead, mentor, develop, and guide direct reports, internal teams, and/or external vendors
• Ability to strategize and implement comprehensive project planning documents outlining key goals, scope, timelines, and stakeholders.
• Must be resourceful and able to seek information and required knowledge to execute high-level projects and lead in a confident and intentional manner.
• Ability to oversee projects with a proactive approach and follow-through, prioritizing multiple tasks in a timely, budget-conscious and quality-driven manner.
• Experience using computer applications including spreadsheets, email, word-processing software and web-based systems.
• Approximately 10% travel may be required for TMF transfer receipt/review and/or Inspection Readiness activities. #LI-CS1 #LI-Remote