Clinical Trial Manager, Clinical Operations

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

📋 Description

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

• Ensure that vendor deliverables are completed on schedule, within budget, and adhere to SOPs, FDA regulations, and ICH/GCP guidelines.

• Engage in vendor meetings and oversee the operational plans of vendors.

• Formulate and manage strategies for risk mitigation.

• Analyze key performance indicators and vendor metrics.

• Assist the Study Lead in managing CRO relationships and evaluating study documents and plans.

• Attend CRO and Study Execution Team meetings.

• Contribute to the operational strategy, including startup processes for studies and countries.

• Facilitate site feasibility, selection, initiation, and resolution of issues.

• Monitor and ensure the completeness and quality of the Trial Master File.

• Track and report on vendor progress, escalating issues to internal stakeholders as necessary.

• Aid in managing study vendor budgets and invoicing procedures.

• Summarize vendor performance data and raise study risks to the Study Lead.

• Utilize AI tools to improve personal productivity and work quality.

⛳️ Requirements

• A minimum of 2-3 years of experience in clinical operations within the biotech, pharmaceutical, or CRO sectors.

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

• Proficiency in Microsoft Project and Smartsheets is highly desired.

• Strong ability to communicate proactively, frequently, and effectively.

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

• Capable of working effectively within cross-functional teams.

• Ability to thrive in a dynamic environment requiring a high level of flexibility.

• Willingness to travel up to 10% as needed.

🏝️ Benefits

• Additional discretionary incentives in the form of cash and stock opportunities.

• Support for employee wellbeing.

• Retirement and financial protection benefits.

• Medical, dental, vision, life, and disability insurance options.

• Flexible Time Off (FTO) with no set accrual limit for eligible U.S.-based exempt employees.

• 11 paid company holidays each year.

• 160 hours of paid vacation annually for new hires who are non-exempt employees, RayzeBio employees, and employees based in Puerto Rico.

• 3 optional holidays.

• Paid sick leave.

• Up to two paid volunteer days each year.

• Flexibility in summer hours.

• Leaves of absence available for medical, personal, parental, caregiver, bereavement, or military needs.

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