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Ultragenyx Pharmaceutical, founded in 2010, is a biotechnology company that specializes in bringing products to market to treat rare, ultra-rare, and serious genetic diseases and c
Senior Clinical Trial Manager
Location
United States
Posted
34 days ago
Salary
$161.8K - $199.8K / year
Seniority
Lead
No structured requirement data.
Job Description
Senior Clinical Trial Manager
Ultragenyx Pharmaceutical
Role Description 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. This position is accountable for ensuring high quality deliverables are within timelines and budget, working 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. Qualifications - 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. Benefits - 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. - Benefits vary by region and country.
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