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

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

Job summary

A leading biopharmaceutical solutions organization is seeking a Project Manager I for remote work focusing on cell and gene therapy trials. The role involves managing CAR-T studies, leading start-up processes, and ensuring regulatory compliance. Ideal candidates have 2-4 years of clinical trial experience and a Bachelor's degree in a relevant field. This position offers flexibility, strategic engagement with biotech leaders, and the chance to advance life-saving research.

Benefits

Remote work flexibility

Career growth opportunities

Cutting-edge research participation

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 ensuring trial execution.
• Lead or support study start-up and site activation.
• Serve as key contact for internal and sponsor teams.

Skills

Clinical trial experience

Oncology

Gene-modified cell therapy

GCP/ICH guidelines

Project management tools

Education

Bachelor's degree in Life Sciences

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.

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.

• 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.

Equal Employment Opportunity: Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, sex, sexual orientation, gender identity, religion, age, disability, or any other status protected by applicable law.