Sr. Clinical Trial Manager
$125,000–$160,000 year
On-site · San Diego, California, United States
Job Summary
Sr. Clinical Trial Manager responsible for supporting the effective planning and conduct of one or more ADARx Pharmaceuticals clinical trials in accordance with the protocol, SOPs, ICH-GCP and regulatory requirements. Key duties include overseeing CRA/CTA activities, site qualification/initiation/monitoring/close-out, planning monitor/investigator meetings, contributing to trial plans (Enrollment/Monitoring/Protocol Deviation), managing site budgets/payments, tracking timelines and metrics (CTMS/DM Query), data review (protocol deviations, data listings, queries), IP release and safety reviews, SOP updates, CRO/vendor management, vendor quality metrics, and training/mentoring of staff. Requires strong communication with trial-site staff and investigators, global collaboration, and on-site presence at the San Diego worksite. Qualifications include BS/MS in life/health sciences, 8+ years of trial management/monitoring experience across Phase 1-3, deep knowledge of ICH/GCP/IRB, site monitoring, CRO/vendor management, and ability to work across time zones. The role emphasizes independent work, adaptability, and the ability to present complex scientific data to cross-functional and senior teams. On-site presence is a stated job function. The position is located in San Diego, CA, US, with US work authorization required and a conditional background check as part of the employment process.
Required Qualifications
- BS/MS in life and health sciences (biology, pharmacology, pharmaceutical sciences or equivalent)
- 8+ years of combined managing/monitoring Phase 1, 2, and 3 clinical trials
- Strong knowledge of and strategic clinical operations
- Experience in performing clinical site monitoring visits, including remote visits
- Experience in CRO/Vendor management (domestic/international) monitoring of budget scope
- Excellent organizational, written and verbal communication skills; and effective presentation of complex scientific data to cross-functional and senior management teams
- Proficiency working with Microsoft Office Suite Products
- Ability to work across global time zones (including EU, APAC)
- Willingness to work occasional weekends based on study needs
- Work Authorization: United States (Required)
- Background Check
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