Experienced Clinical Project Manager - Cell & Gene Therapy (Sponsor Dedicated/ Remote: US only)

Role Summary 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. 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. Why Join Us? This role offers the opportunity to do more than manage clinical trials - it's a chance to be at the center of some of the most promising therapeutic advancements in the world.

You'll play a critical role in accelerating the development of treatments that could change patients' lives forever. If you're looking to grow your career while making a real-world impact, we invite you to apply and join a mission that matters. We are always excited to connect with great talent.

This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available. 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. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time.

Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position.

Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.

Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract.

Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

The Company is 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. Discover what our Syneos Health colleagues already know: work here matters everywhere. Work alongside the brightest minds in the biopharmaceutical industry taking down walls and removing barriers to speed our customers' delivery of important therapies to patients.

We are strategic thinkers who actively seek different perspectives, whether across offices or across oceans. Because we solve some of the toughest challenges facing the most prestigious healthcare companies today, you'll gain exposure and be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing.

The diversification and breadth of Syneos Health creates a multitude of career paths and employment opportunities. We're a growing, global company dedicated to advancing our talent past their initial role. Discover what our 29,000 employees already know: work here matters everywhere.

We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients' lives around the world. Selecting us as an employer secures a career in which you're guaranteed to: Partner with the most diverse team of experts in the industry.

From the top down, our people are inspiring. Everyone has a voice and is encouraged to use it. Work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration.

We assemble clinical teams where everyone, from CRAs to senior management, is skilled in the same therapeutic area or customer teams. With this structure, everyone on your team speaks the same language and can deliver unique insights into the therapeutic environment and patient population. We are partners with purpose.

We integrate seamlessly with our customers and do what's best for their success. Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.