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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