About the Role
Syneos Health is seeking a motivated Project Manager I to join a sponsor-dedicated team supporting oncology and cell & gene therapy trials, including CAR-T studies. You will work full-time for a leading biopharmaceutical sponsor while leveraging CRO resources. This role emphasizes early-phase trial execution, operational oversight, and cross-functional coordination across global study teams. Remote work is supported, but proximity to Los Angeles is preferred for periodic in-office collaboration.
Key Responsibilities
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Serve as sponsor-facing project manager for CAR-T and gene therapy trials from startup to closeout.
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Lead study start-up, site activation, enrollment, and site support.
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Coordinate with internal and sponsor teams to ensure timelines, budgets, and milestones are met.
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Track protocol compliance, CAPAs, site quality indicators, and support audit resolution.
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Oversee TMF maintenance, data accuracy, and inspection readiness.
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Manage low-stability endpoint samples and IP processes.
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Assist with risk identification, mitigation planning, and process optimization.
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Facilitate regular communications, status reporting, and governance updates.
Required Skills & Experience
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2–4 years of clinical trial experience, preferably in a CRO setting.
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Experience with oncology, rare disease, or cell-modified gene therapy trials.
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Prior involvement in CAR-T or cell therapy studies preferred.
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Strong knowledge of GCP/ICH guidelines, FDA/EMA regulations, and inspection standards.
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Proficiency in clinical systems (CTMS, EDC, eTMF) and project management tools.
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Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field (or equivalent experience).
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Comfortable with remote work, occasional travel to Los Angeles required.
Why You Want to Work Here
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Sponsor-side experience with CRO support and infrastructure.
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Contribute to cutting-edge cell & gene therapy trials.
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Opportunities for career growth and leadership development.
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Flexible remote work with occasional in-office collaboration.
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Make an impact on therapies that improve patients’ lives.
Benefits & Perks
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Competitive salary and bonus potential.
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Health benefits (Medical, Dental, Vision), 401(k) match, Employee Stock Purchase Plan.
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Flexible PTO and sick leave.
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Opportunities for career development and skill advancement.