I am TMF process owner at Novo Nordisk where I have been responsible for building the TMF maintenance organisation in a global environment and for driving the TMF strategy and collaboration cross functional. Novo Nordisk implemented a brand new eTMF system in April 2020 where I was product owner for the roll-out and onboarding of new studies. I have been 22 years in the pharma industry. The past 10 years dedicated to TMF where I have been project manager in multiple TMF projects with the aim of improving and optimising the TMF process and system (legacy system at the time), centralised TMF quality control and oversight and inspection readiness.