Clinical Trial Manager

Guardant Health, Inc.; United States; Hybrid; USD 116,960 - 160,820; Full time

Job summary

Guardant Health, Inc. is seeking a Senior Clinical Research Associate to lead planning, execution, and oversight of assigned clinical studies, ensuring adherence to GCP, ICH guidelines, and regulatory requirements.

The role collaborates across Medical Affairs, Data Management, Clinical Operations, and Regulatory Affairs, managing CROs, vendors, and sites to achieve study objectives. The position requires 8+ years in pharma/biotech/CRO with 5+ years as a CRA/SCRA, strong project management and

Qualifications

• Bachelor's degree in a scientific/health discipline; advanced degree preferred.
• 8+ years in pharma/biotech/CRO with 5+ years CRA/SCRA experience.
• Experience with global studies, GCP/ICH, FDA regulations, and vendor management.

Responsibilities

• Lead planning, start-up to close-out with GCP/ICH and regulatory compliance.
• Coordinate cross-functional partnerships across Medical Affairs, Data Management, Clinical Operations, Regulatory Affairs, Client Services, Finance, Legal, and vendors.
• Oversee CROs, vendors, and investigational sites, including visits, payments, and monitoring reports.
• Manage study timelines, enrollment, budgets, and vendor payments; identify risks and mitigation strategies.

Skills

GCP knowledge

ICH guidelines

FDA regulations

Vendor management

Budget management

Project management

Cross-functional

Communication skills

EDC systems

Audit readiness

Travel readiness

Education

Bachelor's degree in science/health

Advanced degree (MS/PhD, etc.)

Tools

Microsoft Office

eTMF

EDC systems

Job description

Job Overview

Senior Clinical Research Associate responsible for leading the planning, execution, and oversight of assigned clinical studies, ensuring compliance with GCP, ICH guidelines, regulatory requirements, protocols, and company SOPs.

Responsibilities

• Lead planning, execution, and oversight from study start‑up through close‑out, ensuring GCP, ICH, regulatory, protocol, and SOP compliance.
• 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.
• 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, ensuring 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 as a CRA/Senior CRA.
• Experience working on global clinical studies, including collaboration with teams and sites in Europe and Asia‑Pacific regions.
• 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, managing 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.
• Demonstrated curiosity, sound judgment, and ability to critically evaluate and responsibly leverage AI‑enabled tools in accordance with company policies, ethical standards, and regulatory requirements.

Compensation & Benefits

Primary Location: Remote – Open Position (USA). Base pay range $116,960 – $160,820 (other US locations $116,960 – $160,820; Colorado $123,840 – $170,280). Competitive benefits and optional bonuses, equity not included.

Hybrid Work Model

All U.S. employees living within 50 miles of a Guardant facility are required to be onsite on Mondays, Tuesdays, and Thursdays; remaining days are flexible remote work.

Legal & Equal Opportunity Statement

Guardant Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability. All information will be kept confidential according to EEO guidelines.