Senior Clinical Trial Manager, Clinical Operations

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $119.1k - $144.3k / year

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

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Bristol Myers Squibb

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1887

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Bristol Myers Squibb is a global biopharmaceutical company that is dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. Their areas of focus include cardiovascular health, cell therapy, immunology, and oncology. With a commitment to transforming patient outcomes through pioneering science, Bristol Myers Squibb partners with a worldwide network of researchers, healthcare providers, and other stakeholders. They aim to lead in innovation for patients while fostering diversity and inclusion within their workforce.

📋 Description

• Manage study vendors, including Central Lab, RTSM/IRT, Imaging, and Dosimetry Vendors • Ensure vendor deliverables are on time, within budget, and compliant with RayzeBio SOPs, FDA regulations, and ICH/GCP guidelines • Participate in vendor meetings • Develop and manage vendor study operational plans • Develop and manage risk mitigation strategies • Review key performance indices and vendor metrics • Assist the Study Lead with management of the study CRO • Review Clinical Study Protocol, Informed Consent Forms, study documents, and plans • Participate in CRO and Study Execution Team meetings • Provide input to operational strategy, including study and country start-up • Support site feasibility, selection, initiation, and issue resolution • Track and maintain study documentation, including TMF completeness and quality • Monitor and report study vendor progress • Escalate issues and study risks to internal stakeholders and the Study Lead • Assist with study vendor budgets and invoicing procedures • Summarize vendor performance data • Perform other related duties as assigned

🎯 Requirements

• Minimum 2-3 years clinical operations experience within biotech, pharma or CRO industry • BA/BS degree in a scientific or healthcare discipline preferred • Independent professional who proactively communicates frequently and effectively • Detail and action-oriented, organized and committed to quality and consistency • Ability to work successfully in cross-functional teams • Ability to work in a dynamic environment with a high degree of flexibility • Expertise in Microsoft Project and Smartsheets desired • Uses AI tools to enhance individual productivity and quality of work • Up to 10% travel required

🏖️ Benefits

• Additional discretionary incentive cash • Stock opportunities • Wellbeing support • Retirement and financial protection benefits • Medical insurance • Dental insurance • Vision insurance • Life insurance • Disability insurance • Flexible Time Off (FTO) for U.S.-based exempt employees • 11 paid company holidays per year • 160 hours of paid vacation annually for new hires for non-exempt employees, RayzeBio employees, and employees located in Puerto Rico • 3 optional holidays • Paid sick leave, depending on eligibility • Up to 2 paid volunteer days per year • Summer hours flexibility • Medical, personal, parental, caregiver, bereavement, or military leaves of absence • Annual Global Shutdown between Christmas Day and New Year's Day