Keith Persson

Experience

1. Principal Scientist, Research Science

   Merck

   Apr 2021 — Present · PA, US

   Imaging Trial Support, Global Clinical Trial Operations: • Support clinical trial teams in using scientifically and operationally appropriate analyses of clinical imaging to assess efficacy and safety endpoints in clinical trials for regulatory submissions and internal decisions• Support development of the imaging section of clinical trial protocols to ensure that they follow established standards and that the assessments support the trial endpoints.• Apply Good Clinical Practice and ability to provide support to clinical teams on imaging related issues such as radiation exposure and informed consent language.• Provide technical support for regulatory filings that may include preparing written responses, developing storyboards, and presenting in support of inspections.• Provide input on site data collection methods, forms, and site monitoring.• Manage the use of independent central review in trials supported by an imaging vendor• Lead the development and approval of the imaging requirements to clearly define the scope of work requested by clinical team. Consider specific needs of trial, experience of iCROs, and budgets provided to make recommendations on iCRO selection.• Manage the development and approval of vendor-generated materials including Imaging Review Charters, Site Imaging Manuals, and other documents. This entails providing guidance to and seeking input from internal stakeholders including statistics, clinical science, study management, data management, quality, and regulatory.• Coordinate the development and approval of other documents, processes, and decisions to be implemented by the iCRO; this includes reviewer selection and training, data capture system functions, data transfer specifications, reader performance monitoring plans and metrics.• Guide collaboration between the clinical trial team and the vendor, providing scientific and operational input.• Work with compliance team to support audits and/or review audit findings of iCROs.

Education

• Bellevue University

  Bachelor