Clinical Trials Manager, Clinical Operations

Bristol Myers Squibb; United States; À distance; USD 135 000 - 163 000; Plein temps

Avantages offerts par ce poste

Flexible Time Off

11 paid company holidays

160 hours paid vacation annually

Stock opportunities

Résumé du poste

RayzeBio, a Bristol Myers Squibb company, is seeking a Clinical Trial Manager, Clinical Operations to oversee the planning and delivery of clinical study timelines within our RayzeBio programs. You will manage CROs and vendors to ensure quality, on-time delivery and budget adherence while aligning with SOPs, GCP/ICH guidelines and FDA regulations.

The role requires 5–7 years of clinical operations experience in biotech/pharma or CRO, a BA/BS in a scientific field, and strong cross-functional

Qualifications

• 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.

Responsabilités

• Lead the planning, execution, and closeout of clinical trials from Phase I-III.
• Oversees and manages CROs and vendors to ensure studies are completed on time, within budget, and in compliance with 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; escalates 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, review key CRO and vendor study operational plans and provide input to operational strategy.
• 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.

Connaissances

Independent professional who Pro-ActiV

Formation

BA/BS degree, scientific or healthcare discipline preferred

Outils

Microsoft Project

Smartsheets

Description du poste

Life at BMS

At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact-on our science, on our teams, and most importantly, on patients. Learn more about RayzeBio: https://careers.bms.com/rayzebio/

RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals

Clinical Trial Manager, Clinical Operations

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

Essential duties and responsibilities include the following. Other duties may be assigned.

• 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; escalates 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

Work Environment

The noise level in the work environment is usually moderate.

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

Compensation Overview:

Remote - United States - US: $134,505 - $162,988

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits:

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.

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, employees may also have access to additional time-off benefits, including 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.

U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

RayzeBio and Bristol Myers Squibb

RayzeBio was acquired by Bristol Myers Squibb (BMS) in 2024 and is a wholly‑owned subsidiary of BMS; however, RayzeBio will continue to operate as a standalone organization.

Supporting People with Disabilities

BMS and RayzeBio are dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS and RayzeBio will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only:

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.