Project Manager - Cell & Gene Therapy; Sponsor Dedicated - US Remote; Preference Los Ange

Project Manager I – Cell & Gene Therapy

Location:

Los Angeles, CA (remote enabled; preference for candidates located near the sponsor’s Los Angeles office).

We are seeking a skilled and motivated Project Manager I to join our sponsor‑dedicated team supporting high‑impact oncology and cell & gene therapy trials, including CAR‑T studies. The role focuses on early‑phase trial execution, operational oversight, and cross‑functional coordination across global study teams.

• Serve as a sponsor‑facing project manager, ensuring successful execution of assigned CAR‑T and gene therapy trials from startup through closeout.
• Lead or support study start‑up, site activation, and enrollment in collaboration with site monitors, regulatory teams, and contracts personnel.
• Act as a key point of contact across internal (CRO) and sponsor teams, facilitating regular communications, status reporting, and governance updates.
• Coordinate cross‑functional stakeholders to ensure timelines, budgets, and milestones are met 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 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 willing to collaborate in person in Los Angeles when required.

The benefits for this position may include a company car or car allowance; medical, dental, and vision health benefits; company match 401(k); eligibility to participate in an Employee Stock Purchase Plan; eligibility to earn commissions/bonus based on company and individual performance; and flexible paid time off (PTO) and sick time. Eligibility for paid sick time may vary by jurisdiction.

The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on qualifications, skills, competencies, and proficiency for the role.

Syneos Health is committed to compliance with the Americans with Disabilities Act, including providing reasonable accommodations to assist employees or applicants in performing essential job functions when appropriate.