Responsibilities
- Act as a 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.
- 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.
- 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.
- 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.
Requirements
- Minimum of a Bachelor's Degree
Nice to Have
- specialization in Health/Life Sciences, Clinical Research or Medical Imaging
Additional Information
- 1-year contract
