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

Syneos Health/ inVentiv Health Commercial LLC; South Dakota; Remote; USD 70,000 - 90,000; Full time

Job summary

A leading biopharmaceutical solutions organization is seeking a Project Manager I to manage CAR-T and gene therapy trials. This role involves overseeing trial execution, ensuring compliance, and coordinating with various stakeholders. Ideal candidates will have 2-4 years of experience in clinical trials, preferably in oncology. The position allows for remote work with occasional in-office collaboration in Los Angeles.

Qualifications

• 2-4 years of clinical trial experience, ideally in a CRO setting.
• Prior involvement in CAR-T or cell therapy studies is highly desirable.
• Familiarity with FDA/EMA regulations and inspection-readiness standards.

Responsibilities

• Act as the main project manager for CAR-T and gene therapy trials.
• Lead study start-up and site activation processes.
• Ensure compliance with protocols and manage quality indicators.

Skills

Clinical trial experience

Oncology expertise

GCP/ICH guidelines knowledge

Proficiency in clinical systems

Project management skills

Education

Bachelor's degree in Life Sciences or related field

Tools

CTMS

EDC

eTMF

Job description

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

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us 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, innovating as a team to help our customers achieve their goals.

Job Responsibilities

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.

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

What You Will Do

• 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 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 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.

Syneos Health is an Equal Opportunities Employer.