Lead the planning, execution, and closeout of clinical trials from Phase I–III
Oversees and manages CROs and vendors to ensure that the study(ies) are completed on time, within budget, and in compliance with RayzeBio SOPs, FDA regulations and ICH/GCP guidelines
Leads the cross-functional study execution team in achieving the study goals and deliverables
Plan and execute study timelines
Monitor study progress, including enrollment, site performance, data quality, and key risk indicators and proactively escalates issues to key internal stakeholders to ensure timely resolution of issues
Identify, assess, and mitigate operational risks; escalate issues as needed
Manage study CRO and vendor budgets and invoicing procedures according to study contract
Lead/support country and site feasibility, selection, and activation strategies
Active participant in CRO and vendor meetings, responsible to review key CRO and vendor study operational plans and provides input to operational strategy, including country and site feasibility and start-up
Summarizes CRO, vendor and site performance data and escalates study risks to the Clinical Operations Program Lead / Head of Clinical Operations
Requirements
Minimum 5-7 years clinical operations experience within biotech, pharma or CRO industry
BA/BS degree, 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.
Tech Stack
Google Cloud Platform
Benefits
Health Coverage: 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.
Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Based on eligibility*, additional time off for employees 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 Years Day.