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

Syneos Health/ inVentiv Health Commercial LLC; New York (NY); Remote; USD 80,000 - 120,000; Full time

Job summary

A leading biopharmaceutical solutions organization is seeking a Project Manager I to support high-impact oncology and cell & gene therapy trials. This role involves managing clinical trial execution and ensuring compliance. Candidates with 2-4 years of experience in clinical trials, particularly in CAR-T studies, are preferred. The position allows for remote work but requires occasional collaboration in Los Angeles. This is an opportunity to advance life-saving research and grow your career intentionally.

Benefits

Remote work flexibility

Career advancement opportunities

Collaborative team environment

Qualifications

• 2-4 years of clinical trial experience, preferably in a CRO setting.
• Prior involvement in CAR-T or cell therapy studies is highly desirable.
• Strong familiarity with GCP/ICH guidelines and FDA/EMA regulations.

Responsibilities

• Act as a sponsor-facing project manager for CAR-T and gene therapy trials.
• Lead study start-up, site activation, and enrollment.
• Ensure inspection readiness and regulatory compliance.

Skills

Clinical trial experience

Knowledge of oncology or gene-modified cell therapy

Familiarity with GCP/ICH guidelines

Proficiency in clinical systems

Strong communication skills

Education

Bachelor's degree in Life Sciences, Nursing, Pharmacy

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.

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.

Role Summary

This position focuses on early-phase trial execution, operational oversight, and cross-functional coordination across global study teams. While remote work is supported, we strongly prefer candidates located near our sponsor's Los Angeles office to allow for periodic in-office collaboration and faster integration with the sponsor team.

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.

Why You Want to Work Here

• Work sponsor-side, stay CRO-strong: This sponsor-dedicated role offers the visibility and strategic engagement of working directly with a biotech leader, while maintaining CRO support and infrastructure.
• Advance life-saving research: Be a part of cutting-edge cell and gene therapy trials, helping bring breakthrough therapies to patients faster.
• Grow your career intentionally: Gain exposure to high-impact projects with opportunities to step up into larger roles and leadership paths.
• Collaborate where it counts: Enjoy the flexibility of remote work with access to in-office opportunities that foster deeper team integration and mentorship.
• Be mission-aligned: Work with a team that shares your urgency, attention to detail, and dedication to patients battling cancer and rare diseases.

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. We are an equal opportunities employer and welcome applications from all qualified candidates.