Job Details

Overview

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

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 on the customer and patient, with a focus on simplifying and streamlining work. This role supports sponsor-dedicated projects with CRO resources, enabling collaboration and expedient delivery of therapies.

Work here matters everywhere.

Responsibilities

• 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.

Skills and Experience

• 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.

Why You Want to Work Here

• Work sponsor-side, stay CRO-strong: This sponsor-dedicated role offers the visibility and strategic engagement of working directly with a biotech leader, while maintaining CRO support and infrastructure.

• Advance life-saving research: Be part of cutting-edge cell and gene therapy trials, helping bring breakthrough therapies to patients faster.

• Grow your career intentionally: Gain exposure to high-impact projects with opportunities to step up into larger roles and leadership paths.

• Collaborate where it counts: Enjoy the flexibility of remote work with access to in-office opportunities that foster deeper team integration and mentorship.

• Be mission-aligned: Work with a team that shares urgency, attention to detail, and dedication to patients battling cancer and rare diseases.

Why Join Us?

This role offers the opportunity to do more than manage clinical trials it's a chance to be at the center of some of the most promising therapeutic advancements in the world. You'll play a critical role in accelerating the development of treatments that could change patients' lives forever. If you're looking to grow your career while making a real-world impact, we invite you to apply and join a mission that matters.

At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. The benefits for this position may include a company car or car allowance, Health benefits, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Syneos complies with all applicable paid sick time requirements.

Salary Range: 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.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health at

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign other tasks at its sole discretion. Equivalent experience, skills, and/or education will be considered. This description is not a contract. The Company is committed to compliance with the Americans with Disabilities Act, including reasonable accommodations when appropriate.