Project Manager I - Cell & Gene Therapy (Sponsor Dedicated - US Remote; Preference for Hybrid L[...]

Project Manager I – Cell & Gene Therapy (Sponsor Dedicated) Location: Los Angeles, CA (near Westwood / UCLA campus). Remote work is supported; however we strongly prefer candidates located near our sponsor’s office to allow periodic in‑office collaboration. Role Summary We are seeking a motivated Project Manager I to support early‑phase oncology and cell & gene therapy trials, including CAR‑T studies. The position focuses on trial execution, operational oversight, and cross‑functional coordination across global study teams. What You Will Do 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, especially 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. Skills and Experience You Have 2‑4 years of clinical trial experience, preferably in a CRO setting, focused 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 (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. Compensation and Benefits Salary Range: $80,600.00 - $145,000.00. Benefits may include a company car or car allowance, health benefits (Medical, Dental and Vision), company match 401(k), Employee Stock Purchase Plan eligibility, performance‑based commission/bonus, and flexible paid time off and sick time. Eligibility for paid sick time may vary by location. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Equal Opportunity Employment The Company is committed to compliance with the Americans with Disabilities Act and provides reasonable accommodations to assist employees or applicants to perform the essential functions of the job. The Company complies with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive in relation to recruitment and employment. #J-18808-Ljbffr Remote Jobs