Judith Harris
Head of Quality Systems and Project Management

Ms. Harris has 20 years of experience in clinical trials and the drug development arena.  Ms. Harris has overall responsibility for compliance and quality systems at PROMETRIKA with oversight of the company’s computer systems validation, training program, sponsor audits and internal and external audits.  Ms. Harris also leads the project management effort at PROMETRIKA, ensuring efficient project team communications and adherence to project timelines and budgets. 

Prior to joining PROMETRIKA, Ms. Harris served as Project Manager at Muro Pharmaceutical/Viatris, Inc., which she joined in 1997 and worked as a pivotal member of the drug development team in the areas of clinical trials management, project management, and medical writing.  Her responsibilities included establishing and coordinating multidisciplinary global project teams, ensuring timelines supporting dossier submissions were met, coordinating project budgets and tracking actual expenditures, writing study reports, INDs, NDAs, and investigator brochures, and preparing IND and NDA submissions.

Prior to joining Muro, Ms. Harris was employed at Biopure Corporation, a biotechnology company in Cambridge, MA for 10 years.  During her tenure at Biopure, Ms. Harris participated on the Clinical Development Board; developed, trained and managed the in-house clinical research team; and oversaw clinical project management of several Phase 1 and Phase 2 clinical trials.

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