Imaging Research and Development Associate
图像研究与开发助理将协助临床项目管理，数据管理和医疗领导团队提供中央影像管理解决方案 (CIMS) 临床试验的医学，科学和运营建议/支持。与内部和外部项目团队作为帮助中心阅读相关的问题/问题的联系点。在文档开发，中央读者培训和质量监测方面与内部和外部利益相关方合作，并协助分析 CIMS 临床试题的图像服务和产品供应。支持部门和公司实现目标和战略目标。试验管理支持 (30-40%) · 在医疗/科学问题/与中央阅读相关的项目团队内部和外部接触点。· 与 Alimentivs 医学领导层，科学顾问/合作者以及/或中央阅读者进行互动和/或升级问题。· 如需要参加内部和赞助商会议。· 与项目团队协作，参与分析和实施项目特定成像要求 （例如质量控制流程，中心阅读范式等）. · 负责开发项目特定图像审查宪章) 和如有所需，中央阅读器变化监测文件。· 参与 CIMS 项目具体文件的开发 （例如工作指令，过程流程，说明书等）. · 在基于科学/医学信息和/或实践的场地训练材料和评分指数的编制和维护中协助。中央阅读过程支持 (30-40%) ·帮助制定和/或审查针对成像系统的评分和利用的中心阅读者培训材料。· 参加项目及非项目核心阅读者质量监测活动和培训。·协助定期及专期对中央阅读统计数据输出和/或原始数据进行审查，以确定问题/趋势。·参与与中央阅读相关的减轻策略和流程改进的开发。·作为 Alimentivs 的接触点 医疗领导力关于中心阅读问题的联系，过程改进等。
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The Imaging Research and Development Associate will assist with providing the Clinical Project Management, Data Management and Medical Leadership teams with medical, scientific, and operational advice/support for Central Image Management Solution (CIMS) clinical trials. Act as a point of contact assisting in issues/matters related to central reading with internal and external project teams. Collaborate with internal and external stakeholders on document development, central reader training and quality monitoring, and assist in analyzing image services and product offerings for CIMS clinical trials. Support the department and company in achieving objectives and strategic goals.
Trials Management Support (30-40%)
- Act as point of contact for internal and external project teams for medical/scientific issues/matters related to central reading.
- Interact with and/or escalate issues to Alimentivs’ Medical Leadership, Scientific Advisors/Collaborators, and/or Central Readers as needed.
- Participate in internal and Sponsor meetings as required.
- In collaboration with the project team, participate in analyzing and implementing project-specific imaging requirements (e.g., quality control processes, central reading paradigms, etc.).
- Lead the development of project-specific Image Review Charter(s) and if applicable, Central Reader Variability Monitoring documentation.
- Participate in the development of CIMS project-specific documents (e.g., Work Instructions, process flows, Instruction Manuals, etc.).
- Assist in the preparation and maintenance of site training materials related to imaging standards and scoring indices based on scientific/medical information and/or practices.
Central Reading Processes Support (30-40%)
- Assist with the development and/or review of central reader training materials specific to scoring and utilization of imaging systems.
- Participate in project and non-project-specific central reader quality monitoring activities and trainings.
- Assist with regular and ad-hoc reviews of central reading statistical data outputs and/or raw data to identify issues/trends.
- Participate in the development of mitigation strategies and process improvements related to central reading.
- Act as a point of contact for Alimentivs’ Medical Leadership regarding central reading issues, process improvements, etc.
Process/Product Design and Improvements (10-20%)
- Collaborate with cross-functional departments to evaluate, implement, and/or provide support for new imaging technologies and/or new/improved processes.
- Participate in the development and maintenance of Standard Operating Procedures, Work Instructions, and associated documents for central reading processes and standards.
- Participate in cross functional imaging modality specific working groups and/or committees.
Research and Development (10-20%)
- Collaborate with Alimenitv's Medical Leadership and Scientific Advisors/Collaborators to assist in the development and maintenance of Alimentiv's standards for imaging and study design.
- Participate in the development and/or improvements of imaging processes related to trial imaging (e.g., central reading paradigms, quality control processes, central reader quality review monitoring, etc.).
- Contribute to the continuous improvement of Imaging Research and Development and the wider organization through information sharing, training, and education.
Qualifications
- Minimum of a Bachelor's Degree (specialization in Health/Life Sciences, Clinical Research or Medical Imaging preferred)
- Strong analytical and problem-solving skills
- Excellent learning agility and ability to work in ambiguity
Accommodations for job applicants with disabilities are available upon request
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Originally posted on Himalayas