Lexington, MA30+ days ago
Establish and track TMF health metrics (completeness, timeliness, quality) Leverage technology (eTMF systems, dashboards, automation) to improve efficiency and visibility Inspection Readiness Leadership Lead the development and implementation of a continuous inspection readiness framework in collaboration with Quality Ensure all studies are maintained in a state of audit readiness at all times throughout the lifecycle of the study Develop, maintain and report on inspections readiness metrics and tools (storyboards and narrative summaries, inspection readiness checklists, document trackers, gap assessments, Partner with Quality to support internal audits, mock inspections, regulatory inspections. Reporting to the VP, Clinical Operations or delegate, the Documentation and Inspection Readiness (DIR) Manager, Clinical Operations is responsible for establishing, overseeing, executing on and continuously improving processes that ensure clinical trial documentation is complete, accurate, inspection-ready, and compliant at all times throughout the lifecycle of Kiniksa's clinical studies.