Trial Master File Operations Specialist

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:

ultrafocused – Work together to fearlessly uncover new possibilities

This position is responsible for the maintenance, quality review, transfer, closure and archival of Sponsor Trial Master File (TMF) essential documentation in accordance with Good Clinical Practice (GCP), E6 ICH Guidelines and other regulatory guidance documents, relevant regulations (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives), and Ultragenyx Standard Operating Procedures (SOPs) as appropriate. The TMF Operations Specialist will provide support to the TMF content owners on one or more clinical programs. This position serves as a pivotal point of contact and works closely with internal Study Management Teams (SMTs) and external CROs/Vendors to ensure that the TMF is complete, accurate, contemporaneous, and inspection ready according to Ultragenyx TMF SOPs and applicable regulations.

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:

• Perform quality reviews of TMF document submissions (uploads) for approval, identify any quality issues (QIs), and follow-up for action completion and QI resolution
• Ensure TMF documentation follows the requirements outlined in study-specific TMF Plans and Indices including but not limited to document classification, expectedness, filing level, naming conventions, metadata assignment, responsibility, filing locations, etc.
• Track periodic and final review intervals and provide TMF full report/inventories for study team review performance; verify review completion and quality issue (QI) resolution and issue TMF periodic and final review completion certificate(s)
• Support TMF final transfer activities for the receipt, review, acceptance, and archival of TMF transfers from external CROs/Vendors
• For specific study TMFs, manage and update applicable TMF Expected Document Lists (EDLs) and milestones in eTMF system.
• Support Clinical Quality Assurance (CQA), SMTs, and Leadership in inspection preparedness and readiness activities
• Support Clinical Quality Assurance (CQA), SMTs, and Leadership in inspection preparedness and readiness activities; Provide content support and TMF guidance including storyboard development, pre-inspection requests, and CAPA response/resolution
• Attend TMF Operations and SMT meetings regularly and provide updates on SMT TMF performance, status updates, trends in identified quality issues, and risk mitigations
• Work cross-functionally with internal departments and external resources (e.g., CROs, Partners, etc.) to resolve gaps in the eTMF

Requirements:

• Bachelor’s degree or equivalent curriculum (scientific or healthcare discipline preferred) and a minimum of 2 years of professional document control experience. Persons without a formal degree who have a minimum of 4 years of training and work experience in document control and who meet job-specific criteria are eligible for consideration.
• Experience with electronic trial master file system(s), workflows, configurations, feature/functionality, and industry best practices for business process alignment
• Advanced knowledge of ICH/GCP Regulations, GDP and ALCOA+ requirements, DIA Reference Model, and industry best practices
• Demonstrated knowledge of Sponsor TMF regul