Essential Duties and 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.

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 of experience as a CRA/Senior CRA.
• Experience working on global clinical studies, including collaboration with teams and sites in Europe and Asia-Pacific regions, preferred.
• 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.

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.

Hybrid Work Model:This section is applicable to onsite employees who are eligible for hybrid work location as specified by management and related policies.  Guardant has defined days for in-person/onsite collaboration and 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. We have found aligning our scheduled in-office days allows our teams to do the best work and creates the focused thinking time our innovative work requires. At Guardant, our work model has created flexibility for better work-life balance while keeping teams connected to advance our science for our patients.

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. Each candidate’s compensation offer will be based on multiple factors including, but not limited to, geography, experience, education, job-related skills, job duties, and business need. Primary Location: Remote - Open Position (USA) Primary Location Base Pay Range: $116,960 - $160,820 Other US Location(s) Base Pay Range: $116,960 - $160,820 If the role is performed in Colorado, the pay range for this job is: $123,840 - $170,280