Syneos Health Inc
Project Manager I Cell & Gene Therapy (Sponsor-Dedicated/ Hybrid- Los Angeles))
Syneos Health Inc, Santa Monica, California, United States, 90403
Overview
Project Manager I Sponsor-Dedicated (Cell & Gene Therapy, Hybrid - Los Angeles). This sponsor-dedicated role supports high-impact oncology and cell & gene therapy trials, including CAR-T studies. You will work full-time on behalf of a leading biopharmaceutical sponsor while employed within a global CRO, offering sponsor collaboration with CRO resources. The role focuses on early-phase trial execution, operational oversight, and cross-functional coordination across global study teams. Remote work is supported, with a strong preference for candidates located near the sponsors Los Angeles office (near Westwood/UCLA) to enable periodic in-person collaboration. Responsibilities
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 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, especially 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 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. Qualifications
24 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. Bachelors degree in Life Sciences, Nursing, Pharmacy, or equivalent work experience. Comfortable with remote work but agreeable to occasional in-person collaboration in Los Angeles. Why Join Us
Work sponsor-side while maintaining CRO support and infrastructure to maximize visibility and collaboration. Contribute to cutting-edge cell and gene therapy trials that aim to bring breakthrough therapies to patients faster. Grow your career with exposure to high-impact projects and leadership opportunities. Benefit from remote work with in-office opportunities for deeper team integration and mentorship. Be part of a mission-driven team focused on patients battling cancer and rare diseases. Additional Information
Salary range and benefits are described in the posted job listing and may vary by location and experience. Syneos Health is an equal opportunity employer and complies with applicable employment laws. #J-18808-Ljbffr
Project Manager I Sponsor-Dedicated (Cell & Gene Therapy, Hybrid - Los Angeles). This sponsor-dedicated role supports high-impact oncology and cell & gene therapy trials, including CAR-T studies. You will work full-time on behalf of a leading biopharmaceutical sponsor while employed within a global CRO, offering sponsor collaboration with CRO resources. The role focuses on early-phase trial execution, operational oversight, and cross-functional coordination across global study teams. Remote work is supported, with a strong preference for candidates located near the sponsors Los Angeles office (near Westwood/UCLA) to enable periodic in-person collaboration. Responsibilities
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 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, especially 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 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. Qualifications
24 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. Bachelors degree in Life Sciences, Nursing, Pharmacy, or equivalent work experience. Comfortable with remote work but agreeable to occasional in-person collaboration in Los Angeles. Why Join Us
Work sponsor-side while maintaining CRO support and infrastructure to maximize visibility and collaboration. Contribute to cutting-edge cell and gene therapy trials that aim to bring breakthrough therapies to patients faster. Grow your career with exposure to high-impact projects and leadership opportunities. Benefit from remote work with in-office opportunities for deeper team integration and mentorship. Be part of a mission-driven team focused on patients battling cancer and rare diseases. Additional Information
Salary range and benefits are described in the posted job listing and may vary by location and experience. Syneos Health is an equal opportunity employer and complies with applicable employment laws. #J-18808-Ljbffr