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

Overview

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

Updated: September 8, 2025
Location: USA-MS-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. We simplify and streamline our work to be easier to work with and for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers to accelerate the delivery of therapies and change lives.

Work Here Matters Everywhere

Why Syneos Health

• We develop our people through career development, training, and recognition; with supportive line management and a total rewards program.
• We foster a Total Self culture where you can be authentic; we take care of our people globally.
• Diversity of thoughts, backgrounds, and perspectives helps us create a place where everyone belongs.

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

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

Role Summary

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. You will work full-time on behalf of a leading biopharmaceutical sponsor while employed within a global CRO—combining sponsor collaboration with CRO resources.

This role focuses on early-phase trial execution, operational oversight, and cross-functional coordination across global study teams. Remote work is supported, but periodic in-office collaboration near Los Angeles is preferred for faster sponsor integration.

What You Will Do

• Act 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 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 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 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, 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 Life Sciences, Nursing, Pharmacy, or equivalent work experience.
• Comfortable with remote work but agreeable to occasional in-person collaboration in Los Angeles.

• Why You Want to Work Here
  :

• Work sponsor-side, stay CRO-strong
  :
  Sponsor-dedicated role with visibility and strategic engagement with a biotech leader, while maintaining CRO support.
• Advance life-saving research
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  Contribute to cutting-edge cell and gene therapy trials to bring therapies to patients faster.
• Grow your career intentionally
  :
  Exposure to…