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, Document and Unified Clinical System, Processes and Enabling Solutions
AstraZeneca

Hobson Lopes


Hobson Lopes

Manager, Clinical Archive Management, Regeneron Pharmaceuticals
Regeneron Pharmaceuticals

Stephanie Viscomi


Stephanie Viscomi

Associate Director, TMF Operations
Alexion Pharmaceuticals

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

Karen Roy


Karen Roy

Chief Strategy Officer
Phlexglobal

Chrystal Payne


Chrystal Payne

Clinical Document Manager
Clovis Oncology

Tamika Jackson


Tamika Jackson

Chief Executive Officer
CrO Biosciences

Ruby Scott


Ruby Scott

TMF Project Manager
LMK Clinical Research Consulting

Joanne Malia


Joanne Malia

Director, Clinical Documentation Management
Regeneron

Carol Stotebury


Carol Stotebury

Associate Director, Clinical Records Management
ImmunityBio

Anusha Rameshbabu


Anusha Rameshbabu

Trial Master File Process Specialist
Alexion Pharmaceuticals

Dawn Lundin


Dawn Lundin

Compliance Director
Perelman School of Medicine, University of Pennsylvania

Barbara Novak


Barbara Novak

System and Process Management Lead, Clinical Operations
Kyowa Kirin Pharmaceuticals

Marie-Christine Poisson-Carvajal


Marie-Christine Poisson-Carvajal

Head of TMF & Registry Operations, Information Management, Operations Center of Excellence (CoE), Global Product Development
Pfizer Inc

Larry Fish


Larry Fish

Head of Clinical Compliance Operations
CSL Behring

Supriya Shoroff, MS


Supriya Shoroff, MS

Associate Director - TMF, Clinical Operations
AMAG Pharmaceuticals, Inc.

Donna Dorozinsky


Donna Dorozinsky

President & CEO
Just in TIME GCP

Rick Arlow


Rick Arlow

CEO
Complion

Priya Chaturvedi


Priya Chaturvedi

VP, Clinical Quality Assurance
Eisai

Gordon Bedford


Gordon Bedford

Regulatory Documentation Specialist
Evelo Biosciences

Saurabh Kothari


Saurabh Kothari

Director of Regulatory Affairs
Evelo Biosciences

Paul Fenton


Paul Fenton

President and CEO
Montrium

Laura Naranjo


Laura Naranjo

Associate Director, TMF Operations Clinical Systems & Records Global Clinical Operations & Planning
Daiichi Sankyo

Marion Mays


Marion Mays

Vice President, Expert Services and Consulting Solutions
PHLEXGLOBAL

Lisa Mulcahy


Lisa Mulcahy

Principal Consultant
Mulcahy Consulting, LLC

Alexander Markiel


Alexander Markiel

Director
Nektar Therapeutics

Jim Markley


Jim Markley

Project Lead
Just in Time GC

Rita Verma


Rita Verma

Head of Global Clinical Affairs
Natus

Gillian Gittens


Gillian Gittens

Director, e-Clinical Strategy & Solutions
TransPerfect

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