About the role
Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide. Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma. Legend Biotech is seeking a **Senior Clinical Trial Associate** as part of the **Clinical Operations** team basedin **Somerset, NJ.** **Role Overview** We are seeking a highly skilled and motivated Senior Clinical Trial Associate (Sr. CTA) to join our growing Clinical Operations team to support early-stage clinical development. The Sr. CTA will play a critical role in the execution of complex Phase I/II CAR-T oncology clinical trials by providing high-quality operational, administrative, and coordination support. The ideal candidate will have substantial experience in clinical trial operations and administration, with a strong understanding of clinical trial processes, regulatory requirements, and GCP. This role is critical to ensuring the efficient execution of clinical trials, maintaining regulatory compliance, and providing operational support to cross-functional study teams. **Key Responsibilities** - Provide cross-functional administrative and operational support for study team meetings, advisory boards, investigator meetings, and other study-related forums. - Support Senior Clinical Trial Managers in the day-to-day execution of complex Phase I and Phase II CAR-T oncology trials, ensuring all activities are conducted in compliance with ICH-GCP and applicable regulatory requirements. - Oversee the preparation, organization, and maintenance of trial documentation, including regulatory files, Trial Master Files (TMFs/eTMFs), and study correspondence. - Ensure documentation is current, complete, and compliant with ICH-GCP and company SOPs. - Assist with the planning, start-up, execution, and close-out of clinical trials, including coordination with clinical sites and support of protocol and regulatory compliance activities. - Assist with the preparation, submission, and tracking of regulatory and IRB/IEC documents. - Maintain working knowledge of applicable regulations and standards to support ongoing study compliance. - Schedule and coordinate study meetings, including investigator meetings, site visits, and internal team meetings. - Prepare meeting agendas, document minutes, track action items, and follow up to ensure timely completion. - Assist in tracking trial progress, including site activation, enrollment, monitoring activities, and key study milestones. - Prepare and maintain study status reports and trackers for internal and external stakeholders. - Support data management activities, including query tracking and data reconciliation, in collaboration with Data Management. - Serve as a key liaison between the clinical trial team, vendors, CROs, and investigational sites to ensure clear and timely communication. - Assist with vendor oversight by tracking deliverables, timelines, and resolving operational issues. - Proactively identify operational issues and risks, propose solutions, and escalate to the Senior Clinical Trial Manager or Clinical Operations leadership as appropriate. - Contribute to the development and continuous improvement of clinical operations processes and best practices. - Provide guidance and mentorship to junior CTAs, sharing best practices and contributing to team capability building. **Requirements** - Bachelor’s degree in life sciences, clinical research, or a related field. - Relevant certifications (e.g., CRC, CRA) are a plus. - Minimum of 3–5 years of experience as a Clinical Trial Associate or in a similar clinical research role. - Demonstrated experience supporting trial coordination, regulatory documentation, and site management activities. - Oncology trial experience required; cell therapy and/or CAR-T experience strongly preferred. - Strong understanding of ICH-GCP, regulatory requirements, and clinical trial processes. - Proficiency with CTMS, eTMF, and EDC systems. - Excellent organizational skills with the ability to manage multiple priorities in a fast-paced environment. - Strong written and verbal communication skills. - Detail-oriented with strong analytical and problem-solving skills. - Ability to work independently and collaboratively within cross-functional teams. - Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and familiarity with eTMF and EDC platforms. #Li-RP1 #Li-Hybrid **Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.** **Work Authorization & Employment Eligibility** Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates. **EEO Statement** It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances. Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. For information related to our privacy notice, please review: [Legend Biotech Privacy Notice](https://legendbiotech.com/privacy-notice/).