BBOT · 10 hours ago
Senior Clinical Trials Manager
United States
Full-time
Remote
Senior Level, Lead/Staff
$171K/yr - $195K/yr
8+ years expBBOT is a clinical-stage biopharmaceutical company advancing a next-generation pipeline of novel small molecule therapeutics targeting RAS and PI3K malignancies. They are seeking a Senior Clinical Trials Manager to support the execution of clinical trials across all phases, focusing on early-phase oncology, and ensuring high-quality, timely clinical data delivery.
Biotechnology
Responsibilities
Support the Associate Director in overseeing global clinical trial execution, including site activation, enrollment, monitoring, and closeout
Support the Associate Director in leading cross functional trial team meetings and ensure alignment on key deliverables, timelines, and risk mitigation strategies
Manage day-to-day operational activities for assigned studies, ensuring adherence to timelines, budgets, and quality standards
Drive vendor integration strategies to ensure seamless execution between CRO, central labs, and any specialty service providers
Act as the main clinical operations point of contact for assigned study-level tasks, including managing CROs and vendors in collaboration with the Associate Director
Ensure completeness and inspection-readiness of the trial master file (TMF/eTMF)
Support the development and maintenance of key operational documents including study manuals, ICFs, tracking tools, and monitoring plans
Participates in the conduct of audits and support regulatory inspections related to GCP
Monitor regulatory and GCP compliance across trial activities and support audit/inspection readiness
Review clinical trial data listings to support identification and resolution of protocol deviations, data trends, and outstanding queries
Own CRO and vendor oversight by tracking deliverables, proactively identifying risks until issue resolution, and performance metrics in partnership with the Program/Study Lead
Oversee lab sample management processes, including sample tracking, shipment, reconciliation, and vendor coordination to ensure timely and compliant handling of biological specimens
Contributes to continuous process improvement and SOP development
Participate in team meetings, providing clinical operations insights and updates to internal stakeholders
Mentor junior team members as needed to build internal operational capabilities
Qualification
Required
Bachelor's degree in life sciences or related field
Minimum 8 years of experience in Clinical Operations, working with CROs and other vendors
Strong understanding of CRO/vendor oversight and clinical development process
Excellent project management, communication, and problem-solving skills
Working knowledge of ICH-GCP and global regulatory requirements
Proficient in clinical trial systems (e.g., EDC, CTMS, eTMF) and Microsoft Office Suite
Preferred
Early-phase oncology experience preferred
Prior experience in a lean or startup environment is highly desirable
Benefits
Annual bonus
Stock-based long-term incentives
Medical, dental, and vision benefits
Retirement
Wellness stipend
Flexible time off
Company
BBOT
BBOT (BridgeBio Oncology Therapeutics) is a clinical-stage biopharmaceutical company advancing a next generation pipeline of novel small molecule therapeutics targeting RAS and PI3K malignancies.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase