Clinical Trials Manager, Clinical Operations

Bristol Myers Squibb
•$134,505 - $162,988•Remote

About The Position

The Clinical Trials Manager, Clinical Operations oversees, plans, and delivers assigned clinical studies within RayzeBio programs. The role manages the study CROs and vendors in accordance with corporate and program SOPs, GCP/ICH guidelines, and applicable federal and state regulations, with the goal of completing studies to established timelines and budgets and at the highest quality. The manager leads clinical trials from Phase I through Phase III, coordinates cross-functional study execution, and monitors enrollment, site performance, data quality, risks, and deliverables. The position may require up to 20% travel. The work environment typically has a moderate noise level.

Requirements

  • Minimum 5–7 years of clinical operations experience within the biotech, pharmaceutical, or CRO industry.
  • Ability to communicate proactively, 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.

Nice To Haves

  • BA/BS degree in a scientific or healthcare discipline preferred.
  • Expertise in Microsoft Project and Smartsheets desired.

Responsibilities

  • Lead the planning, execution, and closeout of Phase I–III clinical trials.
  • Oversee and manage CROs and vendors to ensure studies 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 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 internal stakeholders for timely resolution.
  • Identify, assess, and mitigate operational risks; escalate issues as needed.
  • Manage study CRO and vendor budgets and invoicing according to study contracts.
  • Lead or support country and site feasibility, selection, and activation strategies.
  • Participate in CRO and vendor meetings; review key 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 or Head of Clinical Operations.
  • Perform other related duties as assigned.

Benefits

  • Eligible employees may participate in benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance, subject to applicable plan terms and eligibility.
  • U.S.-based exempt employees are eligible for Flexible Time Off without a set accrual limit, subject to manager approval, and 11 paid company holidays annually.
  • Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires, subject to manager approval, 11 paid company holidays, and 3 optional holidays.
  • Depending on eligibility, additional time-off benefits may include paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs.
  • Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
  • Eligible employees may receive discretionary incentive cash and stock opportunities.
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