Faculty

Thought Leaders

Pawel Rucki


Pawel Rucki

Senior Manager, TMF Operations Clinical Operations Excellence
GW Pharmaceuticals

Supriya Shoroff


Supriya Shoroff

Head of TMF Operations
AMAG Pharmaceuticals

Andrew Bentley


Andrew Bentley

QA Manager
MiNA Therapeutics

Donna Dorozinsky


Donna Dorozinsky

President & CEO
Just in TIME GCP

Fiona MacKenzie


Fiona MacKenzie

Manager, TMF and Document Systems
Alnylam Pharmaceuticals

Amy Klawitter


Amy Klawitter

Director, Integrated Clinical Management
Evotec

Mark Choe


Mark Choe

eTMF SME

Laura Naranjo


Laura Naranjo

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

Rachelle Longest


Rachelle Longest

Clinical System Specialist
Smith & Nephew

Sergi Hernandez Ranzani


Sergi Hernandez Ranzani

Clinical Quality Assurance Specialist
Grifols

Lisa Mulcahy


Lisa Mulcahy

Principal Consultant
Mulcahy Consulting, LLC

Donatella Ballerini


Donatella Ballerini

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

Dawn Lundin


Dawn Lundin

Compliance Director
Perelman School of Medicine, University of Pennsylvania

Wendy Trimboli


Wendy Trimboli

Sr. Director, Clinical Operations Process, Systems & Inspection Readiness
ACADIA Pharmaceuticals Inc.

Stephanie Viscomi


Stephanie Viscomi

Associate Director, TMF Operations
Alexion Pharmaceuticals

Barbara Novak


Barbara Novak

System and Process Management Lead, Clinical Operations
Kyowa Kirin Pharmaceuticals

Sahana Simon


Sahana Simon

Team Lead, TMF Operations
Alimentiv

Maria Palombini


Maria Palombini

Director, Communities & Opportunities Development; Healthcare Life Sciences Practice Leader
IEEE-Standards Association

Joanne Malia


Joanne Malia

Director, Clinical Documentation Management
Regeneron

Amy Lounsbury


Amy Lounsbury

Research Director
MNGI Digestive Health

Ronla Prince


Ronla Prince

TMF Services Lead, Document and Unified Clinical System, Processes and Enabling Solutions
AstraZeneca

Anusha Rameshbabu


Anusha Rameshbabu

Trial Master File Process Specialist
Alexion Pharmaceuticals

Dawn Niccum


Dawn Niccum

Sr. Director, QA and Compliance
Inseption Group

Karen Roy


Karen Roy

Chief Strategy Officer
Phlexglobal

Aaron Grant


Aaron Grant

VP Solutions Consulting
Phlexglobal

Marion Mays


Marion Mays

Vice President, Expert Services and Consulting Solutions
PHLEXGLOBAL

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