Senior Clinical Trial Manager

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $161.8k - $199.8k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Ultragenyx

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2010

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Ultragenyx is a biopharmaceutical company dedicated to transforming the lives of individuals with rare and ultrarare genetic diseases. The company focuses on developing and delivering treatments for conditions where no current therapies exist, utilizing a variety of drug modalities tailored to each disease. Ultragenyx boasts a robust and diverse clinical pipeline, with therapies in development for genetic diseases such as Wilson Disease, osteogenesis imperfecta, and Angelman Syndrome. With a passionate team and a commitment to patient advocacy, Ultragenyx aims to lead the way in pioneering therapies that significantly impact rare disease communities.

📋 Description

• Manage the day-to-day operational aspects of assigned clinical trials or regions, including CRO/vendor management, drug supply management, and clinical site management • Oversee high-impact vendors, including timelines, contracts, invoicing, purchase orders, and forecasting • Oversee development and maintenance of study documents, including study timelines, vendor management plans, risk management plans, informed consent forms, monitoring oversight plans, CRFs, study reference manuals, and dashboards • Lead or actively contribute to Study Management Team meetings • Identify study risks and develop and implement mitigation strategies • Oversee the Trial Master File, completeness reviews, and essential document list • Support study budgeting, including review of clinical trial financial accruals • Manage direct reports • Represent Clinical Operations on initiatives and potentially lead initiatives • Ensure study start-up through close-out activities comply with SOPs and applicable clinical-trial regulations • Ensure high-quality deliverables are completed within timelines and budget

🎯 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

🏖️ 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 • Annual bonus and equity incentives