We are embarking on an exciting project to bring a digital pathology AI Imaging algorithm to clinical trials and to clinical care. This role will focus on taking the algorithm from R&D environment into a CAP CLIA lab by the end of 2021/beginning of 2022 for use in clinical trials. This role also has the potential for follow on work in 2022.
The project is looking for a skilled senior business analyst, to join our team to perform the following activities:
1. Document the AI workflow for generating a locked release
2. Work to document the requirements for the CAP CLIA vendor
3. Work closely with the selected vendor to transition the model to CAP CLIAlaboratory
4. Provide Imaging expertise alongside the rest of the team and help define the strategy and product to a possible Digital Diagnostic (Software as a Medical device class IIb/III)
5. To author and review documentation to meet the requirements of the project. Documentation is extensive and is required for this project.
The ideal candidate has the following skills:
• Authoring and reviewing documentation
• Preparing and analyzing requirements specifications
• Image analysis, radiology and/or digital pathology device development experience in a regulated setting. AI is advantageous but Imaging is a must.
What are the top 3-5 mandatory and/or minimum requirements?
• Good communication skills and facilitation skills with the ability to work in a team.
• Significant project delivery experience in an Imaging environment
• Science and/or Pharmacovigilance background
• Radiology and/or digital pathology and/or AI background highly desirable.
What are the top 3-5 desirable attributes/qualifications?
• Familiarity with business analysis professional best practices
• Influencing and Innovation skills.
What are the required levels of experience and education?
• Educated to degree level at a minimum.
• Experience of working in a global environment
• Excellent English skills both written and oral
• Stakeholder Management skills