Project Manager I – Cell & Gene Therapy (Sponsor Dedicated - US Remote; Preference for Hybrid Los Angeles, CA)

Job Responsibilities

• 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.
• Cover coordination 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.
• Aid in risk identification and mitigation planning, while continuously optimizing trial execution processes.

Skills And Experience

• 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.
• Confidence 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.

Qualifications

Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.

Benefits

• 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

Pay

$80,600.00 - $145,000.00

Schedule

Full-time