I have 18+ years in pharma development ranging with roles in big pharma, CROs and vendors. I spent 4+ years of that time in pure TMF roles with a vendor working on TMF inspection readiness for 3 years and TMF quality for 1+ year. I am currently leading the TMF efforts at Alnylam, where eTMF was implemented 2 years ago. I am a long-standing member of the Chartered Quality Institute and have a keen interest in optimisation based on Lean principles.