Senior Clinical Trial Associate (Contractor)
Somerset, New Jersey, United States
Company Information
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 and natural killer (NK) cell-based immunotherapy.
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) in 2017. 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.
Legend Biotech is seeking a Senior Clinical Trial Associate (Contractor) as part of the Clinical Operations team based Remote.
Role Overview
We are seeking a highly skilled and motivated Senior Clinical Trial Associate (CTA) to join our dynamic and expanding Clinical Operations team to support further development in early-stage trials. The ideal candidate will have substantial experience in clinical trial support and administration, demonstrating a deep understanding of clinical trial processes and regulatory requirements. This role is crucial in ensuring the smooth execution of clinical trials, maintaining compliance, and supporting the clinical team in various administrative and operational tasks.
Key Responsibilities
- Trial Support: Provide cross-functional administrative support for study team meetings, ad boards, investigator's meetings and any other relevant assembly of the study team. Assist Sr. CTMs in day-to-day management of complex phase 1 CAR-T oncology trials, ensuring that all trial-related activities are conducted in compliance with GCP, ICH guidelines, and regulatory requirements.
- Documentation Management: Oversee the preparation, organization, and maintenance of trial-related documentation, including regulatory submissions, trial master files (TMFs), and study reports. Ensure that all documents are up-to-date and compliant with GCP (Good Clinical Practice) guidelines.
- End to End Trial Coordination: Assist in the planning, initiation, and execution of clinical trials, including coordinating with clinical sites, managing trial documentation, and ensuring adherence to protocols and regulatory requirements.
- Regulatory Compliance: Assist in the preparation and submission of regulatory documents and applications. Maintain knowledge of and ensure compliance with relevant regulations and standards.
- Meeting Coordination: Schedule and coordinate study meetings, including investigator meetings, site visits, and team meetings. Prepare agendas, take minutes, and follow up on action items.
- Tracking and Reporting: Assist in tracking trial progress, including enrollment, site activation, data collection, and monitoring activities. Prepare regular status reports for internal and external stakeholders.
- Site Support: Provide support to clinical trial sites, including scheduling site visits, managing site communications, and assisting with site training and onboarding.
- Data Management: Assist with data collection and management, including verifying data accuracy, managing query resolutions, and supporting data analysis as needed.
- Communication: Act as a liaison between the clinical trial team, vendors, and clinical sites, ensuring clear and timely communication.
- Problem-Solving: Identify and address issues that arise during the trial, providing solutions and escalating issues to the Clinical Trial Manager or Director as needed.
- Training and Mentoring: Provide guidance and mentorship to junior CTAs and other team members, sharing expertise and best practices to enhance team performance.
- Vendor Management: Assist in managing vendor relationships, ensuring timely delivery of services, and resolving any operational issues.
- Process Improvement: Contribute to the development and implementation of processes and best practices as the company builds its clinical operations infrastructure.
Requirements
- Education: Bachelor’s degree in life sciences, clinical research, or a related field. Relevant certifications (e.g., Clinical Research Coordinator (CRC), Clinical Research Associate (CRA)) are a plus.
- Experience: Minimum of 3-5 years of experience as a Clinical Trial Associate or in a similar role within clinical research. Demonstrated experience in trial coordination, regulatory documentation, and site management. Cell therapy and/or CAR-T experience is a plus, but not required.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Strong understanding of GCP, ICH guidelines, and regulatory requirements.
- Excellent organizational skills with the ability to manage multiple tasks and priorities.
- Strong communication skills, both written and verbal.
- Detail-oriented with strong problem-solving abilities.
- Ability to work independently and as part of a team.
- Technical Skills: Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and familiarity with eTMF and EDC platforms.
Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.
Legend Biotech maintains a drug-free workplace.
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