Job Details

Overview

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

Description: Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate 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 benefit both clients and teams. This role supports sponsor-dedicated work and remote collaboration within a global CRO framework.

With 29,000 employees across 110 countries, we are driven to accelerate the delivery of therapies and to change lives.

Location & Job ID: USA-IA-Remote | Job ID: 25101519

Why Syneos Health

• We are dedicated to developing our people through career development, training, supportive management, and a total rewards program.
• We foster a Total Self culture where you can authentically be yourself, with care for our people globally.
• We value diversity of thoughts and perspectives to create an inclusive environment.

Responsibilities

Project Manager I Sponsor Dedicated (Cell & Gene Therapy)

Location: USA Remote with occasional travel to Los Angeles area. Preference for hybrid candidates near the sponsors Los Angeles office (Westwood/UCLA).

• Act as a sponsor-facing project manager for CAR-T and gene therapy trials from startup through closeout.
• Lead or support study start-up, site activation, and enrollment; collaborate with site monitors, regulatory, and contracts teams.
• Serve as a key contact across internal (CRO) and sponsor teams; facilitate 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 protocol compliance, CAPAs, and site-level quality indicators; support audit findings resolution.
• 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; ensure timely lab delivery and site support.
• Assist with risk identification and mitigation planning while optimizing trial execution processes.

Qualifications

• 24 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.
• Ability to lead sponsor calls, present KPIs, and contribute to operational governance.
• Bachelors degree in Life Sciences, Nursing, Pharmacy, or equivalent work experience.
• Comfortable with remote work but open to occasional in-person collaboration in Los Angeles.

Why Join Us

• Work sponsor-side while maintaining CRO strength and infrastructure.
• Contribute to cutting-edge cell and gene therapy trials and bring therapies to patients faster.
• Opportunities to grow your career and take on larger roles and leadership paths.
• Remote work with in-office opportunities for deeper team integration and mentorship.
• Mission-aligned culture focused on patients with cancer and rare diseases.

Compensation & Benefits

The base salary range is provided as a guide and varies based on qualifications, skills, and experience. Benefits may include a company car or car allowance, medical/dental/vision coverages, 401(k) with company match, eligibility for Employee Stock Purchase Plan, bonus eligibility, and paid time off. Paid sick time eligibility varies by location in compliance with local requirements.

Additional Information

All information is believed accurate but is not exhaustive. The company may assign other tasks as needed. Equal Employment Opportunity statements and accommodations for applicants with disabilities are included; for accommodations contact ...@syneoshealth.com.

Summary

We seek a motivated Project Manager I to join a sponsor-dedicated team supporting oncology and cell & gene therapy trials, including CAR-T studies. This role is full-time on behalf of a sponsor while employed within a global CRO, offering sponsor collaboration and CRO resources with remote work and in-person collaboration near Los Angeles as needed.

Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected status. If accommodations are needed, contact ...@syneoshealth.com.