Senior Clinical Trial Manager

Position Summary

The Senior Clinical Trial Manager Sr. (CTM) at Ultragenyx is responsible for managing clinical trials or regions, overseeing vendors, and clinical sites. They manage high-impact vendors, oversee timelines and contracts, and lead study management teams.

Responsibilities

• Manage operational aspects such as CRO/vendor management, drug supply management, and clinical site management
• Oversee development and maintenance of study documents like Study Timelines, Vendor Management Plan, Risk Management Plan, Informed Consent Form, Monitoring Oversight Plan, CRFs, Study Reference Manual, dashboards, etc.
• Lead or contribute to Study Management Team meetings
• Identify and mitigate study risks
• Oversee Trial Master File, Completeness Reviews, and Essential Document List
• Support the study budgeting process, including clinical trial financial accruals
• Manage direct reports
• Represent Clinical Operations on initiatives, may lead initiatives

Requirements

• Bachelor degree or equivalent in scientific or healthcare discipline, with 8+ years of direct work experience in Clinical Research, including international experience from study start-up through close-out
• Capable of independently leading all aspects of a clinical trial
• Effective leadership of cross-functional teams
• Strong planning, organizational, and communication skills
• Able to handle multiple tasks and deadlines, and identify risks and issues and take appropriate actions
• Self-motivated and able to develop solutions for complex problems
• Able to build and maintain positive relationships with various stakeholders

Pay & Benefits

• Typical annual salary range: $161,800—$199,800 USD
• Full-time employees enjoy a range of benefits including generous vacation time, volunteer days, long-term incentive plans, employee stock purchase plans, fitness reimbursement, tuition sponsorship, professional development plans, and more.