Clinical Trials Manager, Clinical Operations
Bristol Myers Squibb
Summary
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 description
Summary
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
- 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
- Performs other related duties as assigned
- Up to 20% travel required
Education and Experience
- Minimum 5-7 years clinical operations experience within biotech, pharma or CRO industry
- BA/BS degree, scientific or healthcare discipline preferred
Skills and Qualifications
- 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
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
- Applies AI to improve team execution and decision-making
Benefits
- Health Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Disability Insurance
- Retirement Benefits
- Financial Protection Benefits
- Flexible Time Off
- Paid Company Holidays
- Paid Sick Leave
- Paid Volunteer Days
- Summer Hours Flexibility
- Global Shutdown
Company overview
Bristol Myers Squibb is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. Founded in 1887 and headquartered in Princeton, New Jersey, the company operates with a unique BioPharma strategy that combines the reach and resources of a major pharmaceutical company with the entrepreneurial spirit and agility of a biotech firm. BMS focuses on transformative therapies in key therapeutic areas including oncology, hematology, immunology, cardiovascular disease, and fibrosis. The company has built a sustainable pipeline of potential therapies and leverages translational medicine and data analytics to deliver the right medicine to the right patient at the right time. With over 10,000 employees worldwide, Bristol Myers Squibb maintains a strong commitment to scientific excellence, patient-centric innovation, and global health equity through its foundation. The company's portfolio includes groundbreaking treatments such as Opdivo (nivolumab) for cancer, Eliquis (apixaban) for cardiovascular conditions, and Orencia (abatacept) for autoimmune diseases, among others.