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

Syneos Health/ inVentiv Health Commercial LLC; Missouri; Remote; USD 80,000 - 100,000; Full time

Job summary

A leading biopharmaceutical solutions organization is seeking a Project Manager I to support oncology and cell & gene therapy trials. The ideal candidate will lead the execution of CAR-T and gene therapy trials, ensuring compliance with regulations and facilitating communications between teams. This role requires 2-4 years of clinical trial experience, particularly in a CRO setting, and a relevant bachelor's degree.

Benefits

Work sponsor-side

Advancement in life-saving research

Intentional career growth

Collaborative environment

Mission-aligned work

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.
• Strong familiarity with FDA/EMA regulations and inspection-readiness standards.

Responsibilities

• Act as a sponsor-facing project manager ensuring successful trial execution.
• Lead study start-up, site activation, and enrollment.
• Serve as a key point of contact across internal and sponsor teams.

Skills

Clinical trial experience

Oncology expertise

GCP/ICH guidelines knowledge

Project management proficiency

Education

Bachelor's degree in a 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.

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.

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.

• 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.
• Track and manage protocol compliance, CAPAs, and site-level quality indicators;
• Ensure inspection readiness and regulatory compliance by overseeing TMF maintenance, data accuracy, and documentation completeness.

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.
• Proficiency in clinical systems (e.g., CTMS, EDC, eTMF) and project management tools.
• Bachelor's degree in a relevant field (Life Sciences, Nursing, Pharmacy, etc.) or equivalent work experience.

What We Offer

• Work sponsor-side, stay CRO-strong
• Advance life-saving research
• Grow your career intentionally
• Collaborate where it counts
• Be mission-aligned

We are committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Syneos Health is an Equal Opportunity Employer.