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

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

Updated: Today
Location: Morrisville, NC, United States
Job :-OTHLOC-1500-2

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Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

Whether you join us in a Functional Service Provider partnership or a Full‑Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.

Location:

strongly prefer candidates located near our sponsor’s Los Angeles office (near Westwood neighborhood/ UCLA campus)

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. In this role, you will work full-time on behalf of a leading biopharmaceutical sponsor while employed within a global CRO—offering the best of both worlds: sponsor collaboration and CRO resources.

This position focuses on early‑phase trial execution, operational oversight, and cross‑functional coordination across global study teams. While remote work is supported, we strongly prefer candidates located near our sponsor’s Los Angeles office to allow for periodic in‑office collaboration and faster integration with the sponsor team.

• 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.

Salary Range: $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…