Description Project Manager I - Cell & Gene Therapy (Sponsor Dedicated - US Remote; Preference for Los Angeles, CA)
Job ResponsibilitiesProject Manager I - Sponsor Dedicated (Cell & Gene Therapy)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 (near Westwood neighborhood/ UCLA campus ) 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.
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.
