Act as a sponsor-facing project manager, ensuring the successful execution of assigned CAR-T and gene therapy trials from startup through closeout
Lead or support study start-up, site activation, and enrollment, working closely with site monitors, regulatory teams, and contracts personnel
Serve as a key point of contact across internal (CRO) and sponsor teams, facilitating regular communications, status reporting, and governance updates
Coordinate with cross-functional stakeholders to ensure timelines, budgets, and milestones are met, particularly in complex, high-touch studies
Track and manage protocol compliance, CAPAs, and site-level quality indicators; support resolution of audit findings
Ensure inspection readiness and regulatory compliance by overseeing TMF maintenance, data accuracy, and documentation completeness
Manage or contribute to the tracking of low-stability endpoint samples and IP-related processes, ensuring timely lab delivery and site support
Assist with risk identification and mitigation planning, while continuously optimizing trial execution processes

2–4 years of clinical trial experience, preferably in a CRO setting, with a focus on oncology, rare disease, or gene-modified cell therapy trials
Prior involvement in CAR-T or other cell therapy studies is highly desirable
Strong familiarity with GCP/ICH guidelines, FDA/EMA regulations, and inspection-readiness standards
Experience working in sponsor-dedicated or embedded roles within a CRO is a plus
Proficiency in clinical systems (e.g., CTMS, EDC, eTMF) and project management tools
Confident in leading sponsor calls, presenting KPIs, and contributing to operational governance
Bachelor’s degree in a relevant field (Life Sciences, Nursing, Pharmacy, etc.) or equivalent work experience
Comfortable with remote work but agreeable to occasional in-person collaboration in Los Angeles

Health benefits to include Medical, Dental and Vision
Company match 401k
Eligibility to participate in Employee Stock Purchase Plan
Eligibility to earn commissions/bonus based on company and individual performance
Flexible paid time off (PTO) and sick time
Company car or car allowance

Project Manager I – Cell & Gene Therapy

Key skills