Description

Legend Biotech is seeking a Senior Clinical Trial Associate (Contractor) as part of the Clinical Operations team based Remotely.

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

Clinical Trial Operations Support

• 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.

Documentation & TMF Management

• 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.

End-to-End Trial Coordination

• 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.

Regulatory & Compliance Support

• 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.

Meeting & Communication Coordination

• 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.

Tracking, Reporting & Data Support

• 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.

Site & Vendor Support

• 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.

Problem Solving & Continuous Improvement

• 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.

Training & Mentorship

• 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.

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Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

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.

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