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

Syneos Health, Inc.; Kentucky; Remote; USD 70,000 - 90,000; Full time

Job summary

A biopharmaceutical solutions organization is seeking a Project Manager I for remote work, focusing on CAR-T and gene therapy trials. Candidates should have 2–4 years of clinical trial experience, preferably in a CRO setting, and a bachelor’s degree in life sciences. This role involves managing trial execution and ensuring compliance with regulations, along with occasional in-office collaboration in Los Angeles.

Benefits

Health benefits (medical, dental, vision)

401k company match

Employee Stock Purchase Plan

Qualifications

• 2–4 years of clinical trial experience, preferably in a CRO setting.
• Prior involvement in CAR-T or other cell therapy studies is highly desirable.
• Bachelor’s degree or equivalent work experience required.

Responsibilities

• Act as a sponsor-facing project manager for CAR-T and gene therapy trials.
• Lead study start-up, site activation, and enrollment.
• Coordinate with stakeholders to meet timelines and budgets.

Skills

Clinical trial experience

Familiarity with GCP/ICH guidelines

Proficiency in clinical systems

Leadership in sponsor calls

Comfort with remote work

Education

Bachelor’s degree in Life Sciences, Nursing, or Pharmacy

Tools

CTMS

EDC

eTMF

Job description

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 the customer and patient experience, with a focus on simplifying and streamlining work to better support clients and teams. This role is sponsor-dedicated with remote work and periodic in-office collaboration near the sponsor’s Los Angeles location.

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. The position focuses on early-phase trial execution, operational oversight, and cross-functional coordination across global study teams.

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.

Qualifications

• 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 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 while maintaining CRO strengths, with visibility and strategic engagement of a biotech leader.

• Advance life-saving research by participating in cutting-edge cell and gene therapy trials.

• Grow your career intentionally with exposure to high-impact projects and leadership opportunities.

• Collaborate where it counts with remote work and occasional in-office opportunities for deeper team integration.

• Be mission-aligned, joining a team focused on patients battling cancer and rare diseases.

Compensation & Benefits

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 qualifications, skills, and proficiency. Benefits may include health benefits (medical, dental, vision), company match 401k, eligibility for Employee Stock Purchase Plan, performance-based incentives, and flexible PTO/sick time. Paid sick time eligibility varies by location in compliance with applicable laws and regulations.

Get to know Syneos Health: Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status. If you require reasonable accommodations to complete any part of the application process, please contact [e-mail].

faketext: This section contains company information for context and is not intended to modify the job description.

Additional Information

Summary: This role offers the opportunity to be at the center of promising therapeutic advancements and to accelerate development of therapies that could change patients’ lives. If you are looking to grow your career while making a real-world impact, we invite you to apply.

Contact information:
Phone: [phone] | Fax: [phone] | Toll-Free: 866-462-7373

Location: USA-Remote with occasional travel to the Los Angeles area. Updated September 8, 2025.

Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, or any other legally protected status. If you require reasonable accommodations to complete this application, please contact [e-mail].