Jackie Roberts

Bio:

Jackie Roberts is currently a Manager of GCP Excellence in Clinical Trials at Takeda Pharmaceuticals specializing support in Oncology studies. Jackie has over 14 years experience in Clinical Trials working with contracting companies, CROs and Sponsors. During her 14 years she has gained expertise in Clinical Operations remote and on site monitoring, site activation, essential document collection, biostatistics data entry and analysis as well as all aspects of document management. She has led several TMF focused teams as functional manager, supported TMF process creation, inspection readiness, KPI and metric tracking and mitigations as well as eTMF system migrations and cross functional collaboration processes.

In her current role she is deeply focused on program acquisition and trial integration all while maintaining an inspection ready trial and associated TMF. She is passionate about leveraging her experience in TMF to impact process innovation and agility for all responsible parties that contribute to a complete and correct Trial Master File.