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 Assistant as part of the Clinical Operations team based in Somerset, NJ (REMOTE).
Role Overview
The Senior Clinical Trial Assistant will provide overall administrative support to the Clinical Operations Department. Experience and knowledge of end-to-end management of clinical trial conduct, knowledge of the pharmaceutical industry, and an understanding of clinical drug development, clinical trials operations, and FDA/ICH regulatory requirements is essential. The position involves working closely with Clinical Operations to support clinical trial efficiencies.
Working closely with Clinical Operations and cross-functional teams, including safety, study monitoring and coordinators, data management, biostatistics, bioanalytics, manufacture, supply chain, regulatory, project management, medical affairs, and quality.
Key Responsibilities
- Provide support to the clinical trial team with many of the tasks involved with conducting clinical trials.
- Provide general administrative support to Clinical Operations.
- Assist clinical operations project team with gathering agenda topics, preparing agenda, scheduling meetings. Liaise with meeting planners, and coordinate logistics for internal or external meetings.
- Attend, participate, prepare, and distribute meeting minutes and action items for both internal and external meetings.
- Liaise with contract organizations, select vendors and other suppliers of project support services to support clinical trial deliverables.
- Cooperate with the project team, accurately updating and maintaining clinical tracking systems. Set-up and maintain tracking system with oversight of manager. Assist with study metrics.
- Contribute to documentation, processes, and set-up activities to facilitate efficient working and effective partnerships with external groups.
- Collaborate with the clinical trial team in taking action to address issues as they arise.
- Support study team in preparing study documents and materials.
- May assist with the creation of Master ICF, protocol, CRFs, and all other associated study documents.
- Support the development of SOPs and best practices to support Clinical Operations and Data Analytics department.
- Contribute to the maintenance of existing electronic Trial Master Files (collect outstanding documents from sites/CROs and archive after study is completed).
- Maintenance and archiving of files and records for multiple clinical trials, collaborating, managing all other files and records in support of the department, and administrative support.
- Assist with implementation of a new eTMF system, to possibly include user acceptance testing and data migration activities. Ensure all study documents are archived based on the appropriate guidelines and policy.
- Provide support for quality assurance activities by collaborating with Clinical QA.
- Support preparations and response to audits, internal review, documentation, etc.
Requirements
- Minimum degree requirements of a bachelor’s degree (BA, BS) in scientific or health care discipline preferred.
- Previous experience in the pharmaceutical industry/biotech. Biotech experience is a plus.
- At least 2 years relevant experience functioning as a Sr. Clinical Trial Assistant.
- Experience as a CTA for cross-functional teams (e.g., Clinical Operations, Data Management, Biostatistics, and programming).
- Experience with and an understanding of clinical trial conduct including study start-up conduct and closure.
- Experience and familiarity with TMF maintenance and Essential Documents. TMF readiness experience: Electronic Trial Master File maintenance, auditing, and reconciliation experience. Experience as the primary responsible party for the management of a Trial Master File (eTMF). Experience with paper and electronic document management systems (eTMF, CTMS, etc.).
- Meeting agenda planning and minute-taking experience is a must.
- Strong attention to detail is a must.
- Able to work in a fast-paced, evolving biotech environment with a focus on quality.
- Good communication skills both oral and written are a must.
- Good computer skills are required.
- Demonstrates collaboration and teamwork.
- Works well with others and understands that collaboration leads to better results.
- Demonstrates ownership and commitment to tasks.
- Demonstrates agility and prioritization in an evolving environment.
- Possesses strong teamwork and communication skills.
- Shows continuous improvement and a commitment to self-management and development. Operates with a continuous improvement mindset and continuously seeks to expand own knowledge and capabilities.
- Proficient with Windows Office (Word, Excel, and PowerPoint) and Adobe Acrobat.
- Excel will be used extensively. Experience with chart development and basic functions are necessary.
- Must be well-organized.
- The ideal candidate must be able to work independently but consistently.
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