EDC Clinical Trial Designer - FSP (Homebased - UK)
职位标题:EDC 临床试验设计师 - FSP (家庭 - 英国)工作地点:利文斯顿,西洛蒂安,英国工作场所类型:远程工作合同类型:全日制工作资深级别:EDC 诊断试验设计员将为新临床试 nghiệm 创建高质量的数据收集工具并促进与临床 eCRF 数据库的设计,开发,文件化,测试和实施相关的活动。预计使用 Oracle InForm/中央设计师或 Veeva CDMS/Studio 来设计 eCRF 表格。此外,EDC 临床试验设计师将确保所有相关标准运营程序,CRF 标准,过程和实验具体指南都被实施并利用以帮助确保生产质量的工作产品以及时间表和交付材料的一致性。工作基本功能总结 · 熟练掌握中央设计师/研究室的以下内容 ·基于协议和研究团队成员的输入了解详细数据收集要求。· 与图书馆合作,并在不存在适当形式时创建新的表格。· 制作注释式学习书籍。·理解工作流程设计,动态表格和事件。· 验证模拟和时间表设计的研究设计。· 测试阶段开发和形式的 QC. · 对数据集成,本地实验室管理,编码功能所需的活动基本理解。· 在现场试验中进行后生产形式变化的设计输入。· 从一个研究构建中学到的经验应用。· 与研究团队举行会议以沟通工作范围,项目时间线以及项目的具体要求。· 保持有关监管要求,行业趋势,基准和数据管理和数据库设计的最佳工作实践的良好知识,通过阅读,参与相关培训和/或协会活动。最低要求 · BA / BS 学位。将考虑相应经验。· 使用电子数据捕获系统使用临床数据管理至少2年的经验。•熟悉临床研究流程和 CDISC/CDASH/SDTM 标准 ·有效口头和书面演示和沟通技能。· 专注于细节,致力于高质量的工作,客户服务和第一次做错误的解决方案。·能够快速管理多项项目任务和成果。
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Job Title: EDC Clinical Trial Designer - FSP (Homebased - UK)
Job Location: Livingston, West Lothian, United Kingdom
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
The EDC Clinical Trial Designer will create high quality data collection tools for new clinical trials and facilitate activities related to the design, development, documentation, testing and implementation of clinical eCRF databases.
Design of eCRF forms using Oracle InForm/Central Designer or Veeva CDMS/Studio is expected. In addition, the EDC Clinical Trial Designer will ensure that all relevant standard operating procedures, CRF Standards, process and trial-specific guidelines are implemented and utilized to help ensure that a quality work product is produced and timelines and deliverables are consistently met.
Summary of the Essential Functions of the Job
- Proficiency with the following in Central Designer/Studio
- Understanding detailed data collection requirements based on the protocol and input from study team members.
- Working with libraries and creating new forms when suitable forms do not exist.
- Producing annotated study books.
- Understanding of workflow design, dynamic forms and events.
- Validation of study design for forms and schedule design.
- Test steps development and QC of forms.
- Basic understanding of activities needed for data integrations, local lab management, coding functionality.
- Input into design of post-production form changes to the live trials.
- Apply lessons learned from one study build to the next
- Ability to conduct meetings with the study team to communicate work scope, project timelines, and project specific requirements.
- Maintain a good working knowledge relative to regulatory requirements, industry trends, benchmarks, and best working practices in data management and database design by reading, participating in relevant training and/or association activities.
Minimum Requirements
- BA/BS degree. Commensurate experience will be considered.
- Minimum of 2 years of Clinical Data Management experience using electronic data capture systems.
- Familiarity with clinical research processes and CDISC/CDASH/SDTM standards
- Effective oral and written presentation and communication skills.
- Strong attention to detail and a commitment to high quality work, customer service and getting things right the first time with minimal errors.
- Ability to manage multiple project tasks and deliverables in a fast-paced constantly changing environment.
- Experience in the planning and management of clinical trials in the biopharmaceutical industry or a related field
This role is not eligible for UK visa sponsorship
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
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Originally posted on Himalayas