Transforming cancer care.
Clinical Trial Manager
Location
Colorado
Posted
1 day ago
Salary
$117.0K - $160.8K / year
Seniority
Lead
Job Description
Clinical Trial Manager
Guardant Health
• 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.
Job Requirements
- 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.
- 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.
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Remote work options
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