Project Manager - Cell & Gene Therapy; Sponsor Dedicated - US Remote; Preference Hybrid L

Project Manager I – Cell & Gene Therapy

Location:

strongly prefer candidates located near our sponsor's Los Angeles office (near Westwood neighborhood / UCLA campus). The position supports high-impact oncology and cell & gene therapy trials, including CAR‑T studies.

• 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.

$80,600.00 – $ – The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.

The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. The Company also complies with the EU Equality Directive and equal‑opportunity laws in the states and municipalities where it operates, and observes applicable federal, state, and municipal paid‑sick‑time requirements.