Project Manager for R&D Team at Autofleet managing core projects and deliveries. Ensure effective collaboration and transparency across multiple project aspects in a dynamic environment.
About the role
- Project Manager I overseeing CAR-T and gene therapy trials for a leading biopharmaceutical sponsor. Ensuring project execution from startup through closeout with internal and sponsor team 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 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
Requirements
- 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
- 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
- Flexible paid time off (PTO) and sick time
- Company car or car allowance
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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