Clinical Trial Manager

Guardant Health

1d • $116,960 - $170,280 • Hybrid

About The Position

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.

Requirements

• Bachelor's degree in a scientific, clinical, or health-related discipline required
• Minimum of 8 years of experience in the pharmaceutical, biotechnology, diagnostics, or CRO industry
• 5+ years of experience as a CRA/Senior CRA
• 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.

Nice To Haves

• Advanced degree (MS, MPH, PharmD, PhD, or equivalent) preferred.
• Experience working on global clinical studies, including collaboration with teams and sites in Europe and Asia-Pacific regions, preferred.
• AI & Digital Fluency: Demonstrate curiosity, sound judgment, and the ability to critically evaluate and responsibly leverage AI-enabled tools in accordance with company policies, ethical standards, and regulatory requirements to improve the efficiency, effectiveness, and quality of work.

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.

Benefits

• The annualized base salary ranges for the primary location and any additional locations are listed below. This range does not include benefits or, if applicable, bonus, commission, or equity.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior