GH
Clinical Trial Manager
Remote - Open Position (USA)
Sponsorship not specified$117k-$161kDetected 12 days ago
GCPProject ManagementStakeholder ManagementClinical TrialsClinical ResearchPatient CareFDA RegulatoryResearchCommunicationCollaborationProblem SolvingMicrosoft OfficeRegulatory Affairs
About the role
- Company Description Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer.
- Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer.
- For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.
Responsibilities
- 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.
- 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.
- 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.
- If you need support, please reach out to Peopleteam@guardanthealth.com
- 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.
Requirements
- 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.
- Proficiency with Microsoft Office applications, eTMF, EDC systems, and other clinical trial technologies.
- Experience supporting regulatory submissions, inspections, and audit readiness activities.
- Employee may be required to lift routine office supplies and use office equipment.
- Ability to sit for extended periods of time.
- A background screening including criminal history is required for this role.
- Bachelor's degree in a scientific, clinical, or health-related discipline required
- 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.
- 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.
Nice to have
- advanced degree (MS, MPH, PharmD, PhD, or equivalent) preferred.
- Experience working on global clinical studies, including collaboration with teams and sites in Europe and Asia-Pacific regions, preferred.
Compensation
- $116,960 - $160,820Other
- $116,960 - $160,820If the role is performed in
- $123,840 - $170,280
Benefits
- Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer.
- This range does not include benefits or, if applicable, bonus, commission, or equity.
Equal opportunity
- All your information will be kept confidential according to EEO guidelines.
This listing is sourced directly from GH's careers page and normalized into a canonical job model.