Clinical Trial Manager

Company Description Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant® is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook. Essential Duties and Responsibilities: - Lead the planning, execution, and oversight of assigned clinical studies from study start-up through closeout, ensuring compliance with Good Clinical Practices (GCP), ICH guidelines, applicable regulatory requirements, study protocols, and company SOPs. - Partner cross-functionally with Medical Affairs, Data Management, Clinical Operations, Regulatory Affairs, Client Services, Finance, Legal, and external vendors to achieve study objectives and timelines. - Oversee and manage CROs, vendors, and investigational sites, including oversight visits, site payment management, and review and approval of monitoring visit reports, as applicable. - Manage study timelines, enrollment metrics, vendor performance metrics, study budgets, and vendor payments. - Proactively identify operational risks, enrollment challenges, and execution barriers, implementing mitigation strategies to ensure successful study completion. - Collaborate with Legal and investigational sites to support contract and budget negotiations and ensure study activities remain within approved scope and financial objectives. - Lead study team meetings and provide regular updates to stakeholders and senior management on study progress, risks, and key milestones. - Contribute to the development and review of study-related documents, including protocols, informed consent forms, laboratory manuals, study plans, site training materials, and SOPs. - Support data review, database lock activities, clinical study reports, regulatory submissions, inspections, and audit readiness efforts. - Ensure appropriate site training and ongoing support to investigators and study personnel, promoting protocol compliance and high-quality study conduct. - Oversee sample management activities and coordinate closely with Clinical Operations to ensure timely and accurate processing of study specimens. - Review and approve study-related invoices and expenditures, ensuring alignment with approved budgets and financial goals. Qualifications: - Bachelor's degree in a scientific, clinical, or health-related discipline required; advanced degree (MS, MPH, PharmD, PhD, or equivalent) preferred. - Minimum of 8 years of experience in the pharmaceutical, biotechnology, diagnostics, or CRO industry, including 5+ years of experience as a CRA/Senior CRA. - Experience working on global clinical studies, including collaboration with teams and sites in Europe and Asia-Pacific regions, preferred. - Strong knowledge of GCP, ICH guidelines, FDA regulations, and global clinical research requirements. - Experience managing CROs, vendors, and external study partners. - Demonstrated project management, organizational, and budget management skills with the ability to manage multiple priorities in a fast-paced environment. - Strong analytical, problem-solving, communication, presentation, and stakeholder management skills. - Proficiency with Microsoft Office applications, eTMF, EDC systems, and other clinical trial technologies. - Experience supporting regulatory submissions, inspections, and audit readiness activities. - Self-motivated, detail-oriented, and capable of working independently while collaborating effectively across cross-functional and global teams.