Description Experienced Clinical Project Manager - Cell & Gene Therapy (Sponsor Dedicated/ Remote: US only)
Job ResponsibilitiesClinical Project Manager I - Sponsor Dedicated (Cell & Gene Therapy)Remote- US Based only 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.
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 Roles within Clinical Project Management job family are responsible for planning, directing, creating and communicating clinical study time-lines. Gathers input from cross-functional teams and creates plans that help the team produce deliverables on schedule. Ensures consistency of clinical study and processes across clinical trials, overseeing and resolving operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations such as site and vendor selection, preparing clinical trial budgets. Ensures studies are conducted within clinical trial protocols, monitoring progress and following up with team members and line managers when issues develop. Implements and prepares the clinical development strategy as outlined by the clinical teams. May develop trial recruitment strategies. Impact and Contribution Includes executives as well as managers, supervisors and team leads providing strategic vision and/or tactical direction across a discipline and/or broader organization. The majority of time is spent overseeing their area of responsibility, planning, prioritizing, and/or directing the responsibilities of employees. Goal are achieved through management of process, policy, and performance of direct and/or indirect reports. Supervises experienced support employees and/or entry individual contributors. Delivers operational results that have moderate impact on the immediate achievement of results for the team. Broad job knowledge in an operational, administrative and/or specialized field, adapts new procedures, techniques, tools, etc. Understands basic management approaches such as work scheduling, prioritizing, coaching and process execution.
