Michele Weitz

Principal, Clinical Operational Excellence and Quality Consulting

A pragmatist on a mission to make clinical trial regulatory requirements meaningful and accessible to a tough crowd, Michele has worked as both an employee and consultant at pharmaceutical companies of all sizes—from 23 to 111,000 employees, in many therapeutic areas and around the world during her years in clinical operations, training, and auditing. She has developed training and presented for Momentum Events, Fierce/ExL/QuestEx, SQA, ACRP, Advanstar|CBI, Barnett International, the Multidisciplinary Association of Psychedelic Studies (MAPS), the Institute for International Research, Arena International, and GSMI.

As Executive Director of Clinical Operations Standards and Innovation (formerly GCP Compliance Operations) at Clovis Oncology, Inc., a company committed to improving the lives of people living with cancer, Michele and her team built ethics and quality into everyday clinical trial operations through developing and executing inspection preparation and participation strategies, advising on GCP compliance issues, responding to audit and inspection findings, developing SOPs and Best Practices, designing and delivering training programs, performing investigations and risk assessments, and managing the TMF system—always with an eye toward how the regulatory requirements came to exist and why they matter to the people who must comply with them.

Talks About
#team #zerocancer #clovisoncology #cancerawareness #prostatecancerawareness

Preferred Locations
#NorthAmerica