Senior Manager, Trial Master File (TMF) Operations at Ultragenyx in

Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work. If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.

Position Summary:

ultraimpact – Make a difference for those who need it most

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

Full Time employees across the globe enjoy a range of benefits, including, but not limited to: · Generous vacation time and public holidays observed by the company · Volunteer days · Long term incentive and Employee stock purchase plans or equivalent offerings · Employee wellbeing benefits · Fitness reimbursement · Tuition sponsoring · Professional development plans * Benefits vary by region and country

Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at talentacquisition@ultragenyx.com.

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