Clinical Trial Manager, Clinical Operations

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

📋 Description

• Lead the planning, execution, and closure of clinical trials spanning Phase I–III.

• Oversee and manage CROs and vendors to ensure that studies are completed on schedule, within budget, and in adherence to RayzeBio SOPs, FDA regulations, and ICH/GCP guidelines.

• Direct the cross-functional study execution team in meeting study objectives and deliverables.

• Develop and implement study timelines.

• Monitor study progress, including recruitment, site performance, data quality, and key risk indicators, while proactively escalating issues to key internal stakeholders to facilitate timely issue resolution.

• Identify, evaluate, and mitigate operational risks; escalate concerns as necessary.

• Manage study CRO and vendor budgets and invoicing processes in accordance with study contracts.

• Lead/support strategies for country and site feasibility, selection, and activation.

• Actively participate in CRO and vendor meetings, responsible for reviewing key operational plans and providing input on operational strategies, including country and site feasibility and initiation.

• Summarize performance data from CROs, vendors, and sites, escalating study risks to the Clinical Operations Program Lead / Head of Clinical Operations.

• Execute other related tasks as assigned.

⛳️ Requirements

• A minimum of 5-7 years of clinical operations experience within the biotech, pharmaceutical, or CRO sectors.

• Bachelor’s degree (BA/BS) in a scientific or healthcare field is preferred.

• An independent professional who communicates proactively and effectively.

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

• Capability to work successfully within cross-functional teams.

• Ability to thrive in a dynamic environment with a high level of adaptability.

• Proficiency in Microsoft Project and Smartsheets is desirable.

• Utilizes AI technologies to enhance team execution and decision-making.

🏝️ Benefits

• Health Coverage: Includes medical, pharmacy, dental, and vision care.

• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).

• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.

• Work-life benefits: Paid Time Off for US Exempt Employees includes flexible time off (unlimited with manager approval), 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico, or RayzeBio employees). For Phoenix, AZ, Puerto Rico, and RayzeBio Exempt, Non-Exempt, Hourly Employees: 160 hours of annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays. Additional time off may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs, and an annual Global Shutdown between Christmas and New Year’s Day. All global employees, full and part-time, who are actively employed and paid directly by BMS at the end of the calendar year are eligible for the Global Shutdown.