Clinical Trial Manager
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Job Description
Clinical Trial Manager overseeing studies for precision oncology company Guardant Health. Leading planning and execution of clinical trials from start to finish, ensuring compliance with GCP and regulatory requirements.
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.
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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