Note: The job is a remote job and is open to candidates in USA. Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. The Clinical Trial Manager will lead the planning, execution, and oversight of clinical studies, ensuring compliance with regulatory requirements and collaborating with various departments to achieve study objectives.
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
Skills
- 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, including 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
- Willingness to travel up to 25% and support teams across multiple time zones
- 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
- Advanced degree (MS, MPH, PharmD, PhD, or equivalent)
- Experience working on global clinical studies, including collaboration with teams and sites in Europe and Asia-Pacific regions
Benefits
- Hybrid Work Model: work-from-home days for individual-focused time
- All U.S. employees who live within 50 miles of a Guardant facility will be required to be onsite on Mondays, Tuesdays, and Thursdays
- Hybrid Work Model: defined days for in-person/onsite collaboration and work-from-home days per management and related policies
- Providing reasonable accommodations in hiring processes for candidates with disabilities, long-term conditions, mental health conditions, or sincerely held religious beliefs
- Annualized base salary ranges do not include benefits or, if applicable, bonus, commission, or equity
Company Overview
Company H1B Sponsorship