Project Manager I – Cell & Gene Therapy (Sponsor Dedicated)

Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. They are seeking a Project Manager I to support high-impact oncology and cell & gene therapy trials, focusing on early-phase trial execution, operational oversight, and cross-functional coordination across global study teams.

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
• 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

Requirements:

• 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
• Strong familiarity with GCP/ICH guidelines, FDA/EMA regulations, and inspection-readiness standards
• 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
• Prior involvement in CAR-T or other cell therapy studies is highly desirable
• Experience working in sponsor-dedicated or embedded roles within a CRO is a plus