Senior Clinical Trial Associate

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 based in Somerset NJ.

Location: Remote

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 includingcoordination with clinical sites and support of protocol and regulatory complianceactivities.
• Assist with the preparation submission and tracking of regulatory and IRB/IECdocuments.
• Maintain working knowledge of applicable regulations and standards to support ongoing study compliance.
• Schedule and coordinate study meetings including investigator meetings site visitsand 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 monitoringactivities 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 andinvestigational 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 theSenior 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 andcontributing to team capability building.

Requirements

• Bachelors degree in life sciences clinical research or a related field.
• Relevant certifications (e.g. CRC CRA) are a plus.
• Minimum of 35 years of experience as a Clinical Trial Associate or in a similar clinicalresearch 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 trialprocesses.
• 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 witheTMF and EDC platforms.

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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.