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

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

Job summary

A leading biopharmaceutical solutions organization is seeking a Project Manager I for oncology and cell & gene therapy trials. The role emphasizes trial execution, operational oversight, and cross-functional collaboration. Ideal candidates have 2-4 years of clinical trial experience, especially in CAR-T studies, and hold a relevant degree. The position offers strong career development opportunities and a commitment to employee well-being.

Benefits

Flexible paid time off

Health benefits

Company match 401k

Employee Stock Purchase Plan

Qualifications

• 2-4 years of clinical trial experience, preferably in a CRO.
• Prior involvement in CAR-T or cell therapy studies is highly desirable.
• Experience working in sponsor-dedicated roles within a CRO is a plus.

Responsibilities

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

Skills

Clinical trial experience

Knowledge of GCP/ICH guidelines

Project management tools

Leadership in sponsor calls

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)

United States, North Carolina

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.

Discover what our 29,000 employees, across 110 countries already know: 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. The role 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.

Skill and Experience Requirements

• 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.

Syneos Health is an Equal Employment Opportunity employer and is committed to providing an environment and culture in which our people can thrive, develop and advance. We offer a range of benefits, including flexible paid time off (PTO) and sick time, health benefits, company match 401k, and eligibility to participate in Employee Stock Purchase Plan.