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

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

Job summary

A leading biopharmaceutical solutions organization seeks a Project Manager I to support high-impact oncology and cell & gene therapy trials. This role involves managing CAR-T studies, ensuring compliance, and facilitating communications with stakeholders. Candidates should possess 2-4 years of clinical trial experience, preferably in a CRO, and a relevant bachelor's degree. The position offers remote work with occasional in-person collaboration in Los Angeles.

Benefits

Valuable benefits

Quality-of-life balance

Qualifications

• 2-4 years of clinical trial experience in a CRO setting.
• Familiarity with FDA/EMA regulations.
• Experience in cell therapy studies preferred.

Responsibilities

• Act as a sponsor-facing project manager for CAR-T trials.
• Lead study start-up and site enrollment activities.
• Coordinate with cross-functional stakeholders for timeline management.

Skills

Clinical trial experience

Oncology knowledge

GCP/ICH guidelines familiarity

Data management

Education

Bachelor's degree in relevant 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. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

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. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

WORK HERE MATTERS EVERYWHERE

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. In this role, you will work full-time on behalf of a leading biopharmaceutical sponsor while employed within a global CRO-offering the best of both worlds: sponsor collaboration and CRO resources.

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.

What We Offer

At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance.

Equal Employment Opportunity

Syneos Health is an Equal Employment Opportunity employer.