Clinical Trial Manager – Senior

🕒 4 days ago

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BBOT

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

BBOT is a biotechnology company developing targeted therapies for cancers driven by RAS signaling and PI3Kα. The company focuses on rational drug design to inhibit the active ON state of RAS and to selectively block RAS-driven PI3K activation, aiming at multiple KRAS mutants and novel approaches to maximize target inhibition. BBOT translates decades of RAS biology research into therapeutic candidates intended to improve outcomes for patients with RAS- and PI3Kα-driven tumors.

📋 Description

• Support the Director in overseeing global clinical trial execution, including site activation, enrollment, monitoring, and closeout • Support the 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 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

🎯 Requirements

• Bachelor’s degree in life sciences or related field • Minimum 4 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