Clinical Trial Specialist

Ultragenyx is a biopharmaceutical company focused on advancing medicines for rare disease patients. The Clinical Trial Specialist provides logistical and operational support for one or more clinical trials, partnering with cross-functional teams to ensure activities from site start-up through close-out are executed per SOPs and applicable regulations.

• Support development, review, and maintenance of study documents (e.g., site instructions, site-specific ICFs, Lab Manual, Pharmacy Binder, Study Reference Manual, study plans).
• Set up and maintain trackers, tools, dashboards, reports, and study metrics to support clinical trials.
• Manage one or more small-scope vendors and support management of more complex vendors as needed.
• Oversee assigned vendor contracts with study lead oversight, including invoicing, purchase order monitoring, and forecasting.
• Support or assume site management responsibilities as assigned.
• File study documents in the electronic TMF, maintain essential document lists, participate in TMF completeness reviews, and serve as a primary contact for Records Management as needed.
• Contribute content to team meetings, including Study Management Team meetings.

• Bachelor’s degree or equivalent (scientific or healthcare discipline preferred).
• Typically 2 years of direct work experience in clinical research.
• Understanding of study phases and general knowledge of their application to clinical development.
• Ability to handle multiple tasks and deadlines, identify issues, and take appropriate actions.
• Self-motivated; able to work on problems of moderate scope and complexity requiring analysis of varied factors.
• Ability to build and maintain positive relationships with management and peers.
• Ability to travel up to 10%.

• Work model: Remote (full-time from home) with occasional travel to company offices or other locations as needed.
• Employment type: Full-time.
• Compensation: Eligible for annual bonus and equity incentives.
• Benefits may include generous vacation and public holidays, volunteer days, long-term incentive/employee stock purchase plan (or equivalent), employee wellbeing benefits, fitness reimbursement, tuition sponsoring, and professional development plans (varies by region/country).