Trial Master File Operations Specialist

Summary

Join Ultragenyx as a TMF Operations Specialist and play a pivotal role in maintaining the quality and integrity of clinical trial documentation. You will be responsible for the maintenance, quality review, transfer, closure, and archival of Sponsor Trial Master Files (TMF). This role requires close collaboration with internal and external teams to ensure TMF compliance with GCP, ICH guidelines, and relevant regulations. The position offers a remote work model with occasional travel. You will support clinical programs by managing and updating TMF documentation, tracking review intervals, and supporting inspection preparedness activities. This role requires a Bachelor's degree or equivalent experience and a minimum of 2 years of professional document control experience.

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 regulatory requirements and an understanding of the range of working procedures relating to it, together with an understanding of Good Documentation Practices (GDP)
• Works under general supervision and guidance. Works with manager to establish priorities and timelines
• Strong computer skills (MS Office) including exposure to data/document management systems
• Must be able to work quickly, prioritize effectively, and show attention to detail
• Effective written/oral communication and interpersonal skills
• Good time management skills, excellent attention to detail, and ability to multi-task in a high-volume environment
• Team oriented and flexible; maintaining integrity and high ethical standards
• Ability to build strong relationships with co-workers of various backgrounds and expertise
• Ability to function at a high level in a team setting whether as group contribution or acting as an individual contributor

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

Preferred Qualifications

Familiarity with international clinical trials, clinical trial documents and document QC process highly desirable

Benefits

• This position is eligible for annual bonus and equity incentives
• 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