[Hiring] Clinical Trial Manager @Bristol Myers Squibb

Role Description

The Clinical Trial Manager, Clinical Operations is responsible for the oversight, planning and delivery of assigned clinical study(ies) within the RayzeBio programs, including oversight and management of the study Clinical Research Organization (CRO) and Vendors according to and in compliance with corporate and program Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) guidelines and other applicable federal (FDA) and state regulations, in order to achieve established study goals within timelines and budget and of the highest quality.

Job Responsibilities

• Lead the planning, execution, and closeout of clinical trials from Phase I–III.
• Oversee and manage 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.
• Lead 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 escalate 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 provide input to operational strategy, including country and site feasibility and start-up.
• Summarize CRO, vendor and site performance data and escalate study risks to the Clinical Operations Program Lead / Head of Clinical Operations.
• Perform other related duties as assigned.
• Up to 20% travel required.

Qualifications

• Minimum 5-7 years clinical operations experience within biotech, pharma or CRO industry.
• BA/BS degree, scientific or healthcare discipline preferred.

Requirements

• 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.
• Applies AI to improve team execution and decision-making.

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.
• Work-life benefits include:
  • Paid Time Off: flexible time off (unlimited, with manager approval), 11 paid national holidays.
  • 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 Year's Day.