Project Manager I - Cell & Gene Therapy (Sponsor Dedicated - US Remote; Preference for Hybrid L[...]

Project Manager I - Cell & Gene Therapy (Sponsor Dedicated - US Remote; Preference for Hybrid Los Angeles, CA) Location: strongly prefer candidates located near our sponsor's Los Angeles office (near Westwood neighborhood/ UCLA campus). 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. 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. 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. Benefits 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 $80,600.00 - $145,000.00 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. #J-18808-Ljbffr Syneos Health/ inVentiv Health Commercial LLC