Senior Clinical Trial Associate
Legend Biotech
August 26, 2026
On-site
Somerset, NJ
Clinical Research and Development
Role Overview
Senior Clinical Trial Associate (Sr. CTA) on the Clinical Operations team to support early-stage clinical development, executing complex Phase I/II CAR-T oncology trials with operational, administrative, and coordination support.
Key Responsibilities
- Provide cross-functional administrative and operational support for study team meetings, advisory boards, investigator meetings, and other study forums.
- Support Senior Clinical Trial Managers with day-to-day execution of Phase I/II CAR-T oncology trials in compliance with ICH-GCP and applicable regulations.
- Oversee preparation, organization, and maintenance of trial documentation (regulatory files, TMFs/eTMFs, correspondence); ensure documents are current, complete, and compliant with ICH-GCP and company SOPs.
- Assist with trial planning, start-up, execution, and close-out; coordinate with sites and support protocol/regulatory compliance.
- Prepare, submit, and track regulatory and IRB/IEC documents; maintain knowledge of applicable regulations and standards.
- Schedule/coordinate meetings (investigator meetings, site visits, internal meetings); prepare agendas, minutes, track action items.
- Track trial progress (site activation, enrollment, monitoring, milestones) and maintain status reports/trackers.
- Support data management (query tracking and data reconciliation) with Data Management.
- Liaison among clinical team, vendors, CROs, and investigational sites; support vendor oversight.
- Identify operational issues/risks, propose solutions, and escalate as appropriate; improve processes; mentor junior CTAs.
Requirements
- Bachelor’s degree in life sciences/clinical research or related field.
- 3–5 years as a Clinical Trial Associate (or similar role).
- Experience with trial coordination, regulatory documentation, and site management.
- Oncology trial experience required; cell therapy and/or CAR-T strongly preferred.
- Strong ICH-GCP/regulatory understanding; proficiency with CTMS, eTMF, and EDC.
- Excellent organization, communication, problem-solving; ability to work cross-functionally.
- Proficiency in Microsoft Office; familiarity with eTMF/EDC platforms.
Benefits
- Benefits are offered exclusively to permanent full-time employees (contractors not eligible).
Work Authorization
- Applicants must be authorized to work in the United States; E-Verify and Form I-9 required if hired.
Senior Clinical Trial Associate (Sr. CTA) on the Clinical Operations team to support early-stage clinical development, executing complex Phase I/II CAR-T oncology trials with operational, administrative, and coordination support.
Key Responsibilities
- Provide cross-functional administrative and operational support for study team meetings, advisory boards, investigator meetings, and other study forums.
- Support Senior Clinical Trial Managers with day-to-day execution of Phase I/II CAR-T oncology trials in compliance with ICH-GCP and applicable regulations.
- Oversee preparation, organization, and maintenance of trial documentation (regulatory files, TMFs/eTMFs, correspondence); ensure documents are current, complete, and compliant with ICH-GCP and company SOPs.
- Assist with trial planning, start-up, execution, and close-out; coordinate with sites and support protocol/regulatory compliance.
- Prepare, submit, and track regulatory and IRB/IEC documents; maintain knowledge of applicable regulations and standards.
- Schedule/coordinate meetings (investigator meetings, site visits, internal meetings); prepare agendas, minutes, track action items.
- Track trial progress (site activation, enrollment, monitoring, milestones) and maintain status reports/trackers.
- Support data management (query tracking and data reconciliation) with Data Management.
- Liaison among clinical team, vendors, CROs, and investigational sites; support vendor oversight.
- Identify operational issues/risks, propose solutions, and escalate as appropriate; improve processes; mentor junior CTAs.
Requirements
- Bachelor’s degree in life sciences/clinical research or related field.
- 3–5 years as a Clinical Trial Associate (or similar role).
- Experience with trial coordination, regulatory documentation, and site management.
- Oncology trial experience required; cell therapy and/or CAR-T strongly preferred.
- Strong ICH-GCP/regulatory understanding; proficiency with CTMS, eTMF, and EDC.
- Excellent organization, communication, problem-solving; ability to work cross-functionally.
- Proficiency in Microsoft Office; familiarity with eTMF/EDC platforms.
Benefits
- Benefits are offered exclusively to permanent full-time employees (contractors not eligible).
Work Authorization
- Applicants must be authorized to work in the United States; E-Verify and Form I-9 required if hired.