Project Manager – Cell & Gene Therapy; Sponsor-Dedicated​/Remote

Overview

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

Updated:
September 29, 2025

Location:

USA-ND-Remote
Job :

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model centers the customer and the patient, with a focus on simplifying and streamlining work to make Syneos Health easier to work with and easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers to help customers achieve their goals. We are agile and driven to accelerate the delivery of therapies because we are passionate to change lives.

Discover what our 29,000 employees across 110 countries already know:
WORK HERE MATTERS EVERYWHERE

• We are passionate about developing our people through career development and progression, supportive line management, technical and therapeutic area training, peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture unites us globally, and we take care of our people.
• We are building the company our customers and employees want to work with by valuing diversity of thoughts, backgrounds, cultures, and perspectives so everyone feels they belong.

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

Location: USA Remote with occasional travel to Los Angeles area. Preference for hybrid candidates near our sponsor’s Los Angeles office (near Westwood/UCLA).

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, benefiting from 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…