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Clinical Trial Manager, Clinical Operations
Bristol Myers Squibb. Manage study vendors, including Central Lab, RTSM/IRT, Imaging, and Dosimetry Vendors .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing study vendors and ensuring compliance with SOPs, FDA regulations, and ICH/GCP guidelines. Proficient in tracking vendor performance and supporting operational strategies within the biotech, pharma, or CRO industry.
Highest-signal resume keywords
Clinical Operations ExperienceVendor ManagementRisk Mitigation StrategiesMicrosoft Project ExpertiseCross-Functional Team Collaboration
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical OperationsVendor Deliverables ManagementRisk MitigationPerformance Metrics ReviewTrial Master File Management
Soft Skills
Proactive CommunicationDetail-OrientedOrganizational SkillsFlexibilityCommitment to Quality
Tools & Technologies
Microsoft ProjectSmartsheetsAI Tools
Industry Keywords
BiotechPharmaCROSOPsFDA RegulationsICH GuidelinesStudy ExecutionSite FeasibilityOperational Strategy
About the role
Key responsibilities & impact- Manage study vendors, including Central Lab, RTSM/IRT, Imaging, and Dosimetry Vendors
- Ensure vendor deliverables are on time, within budget, and compliant with SOPs, FDA regulations, and ICH/GCP guidelines
- Participate in vendor meetings and manage vendor operational plans
- Develop and manage risk mitigation strategies
- Review key performance indices and vendor metrics
- Assist the Study Lead with CRO management and review study documents and plans
- Participate in CRO and Study Execution Team meetings
- Provide input to operational strategy, including study and country start-up
- Support site feasibility, selection, initiation, and issue resolution
- Track and maintain Trial Master File completeness and quality
- Monitor and report vendor progress and escalate issues to internal stakeholders
- Assist with study vendor budgets and invoicing procedures
- Summarize vendor performance data and escalate study risks to the Study Lead
- Use AI tools to enhance individual productivity and quality of work
Requirements
What you’ll need- Minimum 2-3 years clinical operations experience within biotech, pharma or CRO industry
- BA/BS degree in a scientific or healthcare discipline preferred
- Expertise in Microsoft Project and Smartsheets desired
- Ability to proactively communicate 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
- Up to 10% travel required
Benefits
Comp & perks- Additional discretionary incentive cash and stock opportunities
- Wellbeing support
- Retirement and financial protection benefits
- Medical, dental, vision, life and disability insurance offerings
- Flexible Time Off (FTO) without a set accrual limit for eligible U.S.-based exempt employees
- 11 paid company holidays each year
- 160 hours of paid vacation annually for new hires for non-exempt employees, RayzeBio employees, and employees located in Puerto Rico
- 3 optional holidays
- Paid sick leave
- Up to two paid volunteer days per year
- Summer hours flexibility
- Leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
- Annual Global Shutdown between Christmas Day and New Year's Day