Senior Consultant with WCG Avoca, following a 28-year career at Eli Lilly and Company where he was Head of the Lean Six Sigma organization for Clinical Development and Product Development. Additional leadership positions in Clinical Development, Product Development, Clinical Trial Material Supply and Critical Chain Project Management. Led Lilly's change initiative for improving TMF performance.
We can get ourselves into trouble when we treat the management of the TMF as a separate and distinct activity from managing the trial itself. We often wind up with two sets of books—the Compliance TMF and the Real TMF.
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