Senior Clinical Trial Manager Sr. (CTM)

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The Senior Clinical Trial Manager Sr. (CTM) is responsible for the day-to-day management of a clinical trial or region, oversight of vendors, and clinical trial sites. For this study, the role is as a Lead Study Manager. The Senior Clinical Trial Manager (Sr. CTM) is accountable for ensuring high quality deliverables are within timelines and budget. This position will work closely with cross-functional teams to ensure study start-up through close-out activities are conducted in accordance with Standard Operating Procedures (SOPs) and applicable regulations governing the conduct of clinical trials.

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:

• Responsible for the day-to-day management of assigned operational aspects, such as CRO/vendor management, drug supply management, management of clinical sites, etc for assigned region(s) or study(s)
• Manages high impact vendors, including oversight of timelines and contracts (invoicing, purchase order monitoring, and forecasting)
• Oversee development and maintenance of study documents such as Study Timelines, Vendor Management Plan, Risk Management Plan, Informed Consent Form, Monitoring Oversight Plan, CRFs, Study Reference Manual, dashboards, etc
• Lead, or actively contribute to, Study Management Team meetings
• Identify study risks, develop and implement mitigation strategies
• Oversee Trial Master File, Completeness Reviews, and Essential Document List
• Support the study budgeting process, including the review of clinical trial financial accruals
• Manages direct reports
• Represents Clinical Operations on initiatives, may lead initiatives

Requirements:

• Bachelor degree or equivalent is required (scientific or healthcare discipline preferred)
• Typically, 8 years of direct work experience in Clinical Research, with international experience from study start up through closeout preferred
• Fully capable to independently lead all aspects of a clinical trial
• Effective leadership of cross-functional teams
• Excellent planning, organizational, and communication skills
• Able to handle multiple tasks and deadlines, and identify risks and issues and take appropriate actions
• Must be self-motivated and able to develop solutions for a variety of complex problems where analysis requires an in-depth evaluation of variable factors, including inter-organizational impact
• Must have the ability to build and maintain positive relationships with management, peers, vendors, and clinical sites
• 10% travel may be required