Clinical Trial Manager or Sr Clinical Trial Manager

Responsibilities

• 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
• 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
• Maintain 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

Qualifications

• Education and Qualifications – Clinical Trial Manager (CTM): 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, excellent project management, communication, and problem-solving skills
• Qualifications – Senior Clinical Trial Manager (Sr. CTM): Bachelor’s degree in life sciences or related field, minimum 6 years of experience in Clinical Operations, working with CROs and other vendors, strong understanding of CRO/vendor oversight and clinical development process, with demonstrated ability to operate independently across complex, multi-vendor programs, early-phase oncology experience preferred; proven track record managing cross-functional trial teams, prior experience in a lean or startup environment is highly desirable, excellent project management, communication, and problem-solving skills; demonstrated ability to lead and influence without direct authority, working knowledge of ICH-GCP and global regulatory requirements, proficient in clinical trial systems (e.g., EDC, CTMS, eTMF) and Microsoft Office Suite

Pay

$140,000 - $180,000