Senior Clinical Trial Manager
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Job Description
Sr. Clinical Trial Manager leading planning and execution of oncology clinical trials at RayzeBio. Collaborating with CROs and cross-functional teams to ensure compliance with regulatory guidelines.
Responsibilities:
- 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.
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.
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