Malgorzata Michalik

Background

About Malgorzata Michalik

Global Study Assotiate Manager (Global Projects Management) Trial Operation Activities: • Support the Leader (Global Study Manager (GSM)) in all aspects of operational planning, management and execution of clinical studies and program(s) within Trial Operations • Support the Leader (GSM) performing budget management activities such as grant plan requests, local study cost request, validate and track invoices, prepare reports and analytics and perform the final budget reconciliation • Responsible for Vendor Managers, providing study specific information to facilitate proposals, budgets and technical specifications. Participate in regular vendor meetings; escalate issues for resolution, review & reporting • Coordinate Clinical Study Team (CST) meetings • Own the development, preparation, distribution and update of study plans and documents • Prepare study training materials, organize and conduct global FTF or virtual Investigator Meetings • Review audit responses. Support Deviation management process, e-TMF, CSR appendices Global Study Manager (Bioresearch Monitoring & Pre-Approval Inspection)