Matthew Royer
Senior Clinical Trial Specialist @Ultragenyx
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WORK HISTORY
Senior Clinical Trial Specialist @Ultragenyx
Develop and review study documents (e.g, model/country/site ICFs, lab manual, CLS, pharmacy manual, study management plan, vendor management plan, site fan deck, etc.) • Develop and review Standard Operating Procedures• Manage study specific vendors including central and specialty labs, study equipment, and resonance imaging • Europe/Middle East/Africa(EMEA) region lead; sponsor contact for site management issues, inquires, and activities • US LIRB Site Lead: sponsor contact for site management issues, inquires, and activities• Manage the collection, review and approval of regulatory documents from clinical sites • Coordinate investigational product release activities across clinical sites (e.g. Authorization to ship form, RCR review, notification to supply chain)• Manages and tracks study specific invoices/payments• Manages creation and amendments of study specific Budgets/SOWs • Track sample collection, shipments, and test results • Manage country and site feasibility, selection, and initiation during study start-up• Initiate, maintain and reconcile the Trial Master File (Veeva Vault)• Mentor Clinical Trial Associates • Involved in the coordination and running of study specific meetings• Set-up and maintain tracking systems, tools and report study metrics to support the clinical trial
EDUCATION
University of Rhode Island
Bachelor's Degree, Pharmaceutical Sciences
SKILLS
ABOUT MATTHEW ROYER
Senior Clinical Trial Specialist at Ultragenyx
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