Remote Senior Clinical Trial Leader

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

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