1001 Syneos Health, LLC

Compensation

Full Description

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description 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. • 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. Qualifications • 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. Benefits • Opportunity to work sponsor-side while maintaining CRO support and infrastructure. • Be a part of cutting-edge cell and gene therapy trials, helping bring breakthrough therapies to patients faster. • Gain exposure to high-impact projects with opportunities to step up into larger roles and leadership paths. • Enjoy the flexibility of remote work with access to in-office opportunities that foster deeper team integration and mentorship. • Work with a team that shares your urgency, attention to detail, and dedication to patients battling cancer and rare diseases.