Senior Clinical Trial Manager, Clinical Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee study vendors, including Central Lab, RTSM/IRT, Imaging, and Dosimetry Vendors.

• Ensure that vendor deliverables are completed punctually, within budget, and in compliance with RayzeBio SOPs, FDA regulations, and ICH/GCP guidelines.

• Engage in vendor meetings.

• Create and manage operational plans for vendor studies.

• Formulate and oversee strategies for risk mitigation.

• Evaluate key performance indicators and vendor metrics.

• Support the Study Lead in managing the study CRO.

• Review Clinical Study Protocol, Informed Consent Forms, study documents, and plans.

• Attend CRO and Study Execution Team meetings.

• Contribute to operational strategy, including study and country start-up.

• Assist with site feasibility, selection, initiation, and resolving issues.

• Track and preserve study documentation, ensuring TMF completeness and quality.

• Monitor and report on the progress of study vendors.

• Raise issues and study risks to internal stakeholders and the Study Lead.

• Aid in managing study vendor budgets and invoicing processes.

• Summarize performance data of vendors.

• Perform other related tasks as assigned.

⛳️ Requirements

• At least 2-3 years of clinical operations experience in the biotech, pharma, or CRO industry.

• BA/BS degree in a scientific or healthcare-related field preferred.

• A self-motivated professional who communicates proactively and effectively.

• Detail-oriented, organized, action-driven, and committed to maintaining quality and consistency.

• Capable of collaborating successfully within cross-functional teams.

• Ability to thrive in a dynamic environment with a high degree of flexibility.

• Proficiency in Microsoft Project and Smartsheets is desired.

• Utilizes AI tools to enhance personal productivity and work quality.

• Willingness to travel up to 10% as 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 annually.

• 160 hours of paid vacation each year for new hires, non-exempt employees, RayzeBio employees, and employees in Puerto Rico.

• 3 optional holidays.

• Paid sick leave based on eligibility.

• Up to 2 paid volunteer days per year.

• Flexible summer hours.

• Medical, personal, parental, caregiver, bereavement, or military leaves of absence.

• Annual Global Shutdown between Christmas Day and New Year's Day.