Description
Syneos Health is 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.
The successful candidate will work full-time on behalf of a leading biopharmaceutical sponsor while employed within a global CRO. The position focuses on early-phase trial execution, operational oversight, and cross-functional coordination across global study teams.
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:
- Company car or car allowance
- 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
Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.