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Clinical Trials Manager

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Job Description - Clinical Trials Manager



Full-time


Description

About BridgeBio Oncology Therapeutics

BBOT is a clinical-stage biopharmaceutical company advancing a next-generation pipeline of novel small molecule therapeutics targeting RAS and PI3K malignancies. BBOT has the goal of improving outcomes for patients with cancers driven by the two most prevalent oncogenes in human tumors. For more information visit BBOTx.com.

Who You Are

We are seeking a Clinical Trial Manager (CTM) to support the execution of BBOT’s clinical trials across all phases, with a focus on early-phase oncology. Reporting to the Associate Director of Clinical Operations, the CTM will play a critical role in supporting cross-functional planning, day-to-day oversight of trial activities, and ensuring the delivery of high-quality, timely clinical data. The CTM will work closely with internal and external partners, including CROs, vendors, and clinical sites. Global trial experience a plus.

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

Requirements

Education and Qualifications

  • Bachelor’s degree in life sciences or related field
  • Minimum 7 years of experience in Clinical Operations, working with CROs and other vendors
  • Strong understanding of CRO/vendor oversight and clinical development process
  • Early-phase oncology experience preferred
  • Prior experience in a lean or startup environment is highly desirable
  • 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
  • Excellent project management, communication, and problem-solving skills

Salary

The annual salary range for this position is  $152,500 - $175,000  in the San Francisco Bay Area. BBOT considers a variety of factors when determining base compensation, including experience, skills, education, qualifications, and geographic location. Actual compensation will vary, and it is not typical to be hired at or near the top of the range for the role.

Base compensation is part of a robust total rewards offering at BBOT. Additional total rewards elements include annual bonus, stock-based long-term incentives, medical, dental, and vision benefits, retirement, wellness stipend, and flexible time off.


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