Faculty

Thought Leaders

Aryn Knight, BS, CCRP


Aryn Knight, BS, CCRP

Administrative Director, Center for Clinical Research
Texas Heart Institute

Martina Duevel


Martina Duevel

Systems Excellence Project Leader
Bayer AG

Jamie Marie Toth, CPM, MS


Jamie Marie Toth, CPM, MS

Director, Head of TMF Operations, Clinical Development Operations
Daiichi Sankyo, Inc.

Donatella Ballerini


Donatella Ballerini

Document and Training Manager, Global Rare Disease R&D
Chiesi Pharmaceuticals

Sholeh Ehdaivand


Sholeh Ehdaivand

President and CEO
LMK Clinical Research Consulting

Ronla Prince


Ronla Prince

TMF Services Lead, Processes and Enabling Solutions, Development Operations
AstraZeneca

Hobson Lopes


Hobson Lopes

Manager, Clinical Archive Management, Regeneron Pharmaceuticals
Regeneron Pharmaceuticals

Stephanie Viscomi


Stephanie Viscomi

Associate Director, TMF Compliance and Education
Alexion Pharmaceuticals

Sharon Brower


Sharon Brower

CQA, Head of Clinical Training, Process & Continuous, Global Development Operations
Bristol Myers Squibb

Gabriela Gottlieb


Gabriela Gottlieb

Clinical Quality Assurance Manager
Terumo Medical Corporation

Khemraj Hirani, MPharm, PhD, RAC, CIP, CCRP, RPH, MBA


Khemraj Hirani, MPharm, PhD, RAC, CIP, CCRP, RPH, MBA

Associate Vice Chair for Research and Regulatory Compliance, Department of Medicine, Director, Regulatory Affairs Quality Assurance
University of Miami Diabetes Research Institute

Lori Ridge


Lori Ridge

Senior Trial Master File Project Manager, Global Clinical Operations
Mylan

Rachelle Longest


Rachelle Longest

Clinical System Specialist
Smith & Nephew

Lauren Watson


Lauren Watson

Clinical Consultant

Joana Loresto


Joana Loresto

Clinical Documentation Manager
Rigel Pharmaceuticals

Shannon Simpson


Shannon Simpson

Trial Master File Manager
PATH’s Center for Vaccine Innovation and Access

Dawn Niccum


Dawn Niccum

Sr. Director, QA and Compliance
Inseption Group

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