Faculty

Pawel Rucki

Senior Manager, TMF Operations Clinical Operations Excellence
GW Pharmaceuticals

Supriya Shoroff

Head of TMF Operations
AMAG Pharmaceuticals

Andrew Bentley

QA Manager
MiNA Therapeutics

Donna Dorozinsky

President & CEO
Just in TIME GCP

Fiona MacKenzie

Manager, TMF and Document Systems
Alnylam Pharmaceuticals

Amy Klawitter

Director, Integrated Clinical Management
Evotec

Mark Choe

eTMF SME

Laura Naranjo

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

Rachelle Longest

Solutions Architect II
Transperfect Trial Interactive

Sergi Hernandez Ranzani

Clinical Quality Assurance Specialist
Grifols

Lisa Mulcahy

Principal Consultant
Mulcahy Consulting, LLC

Donatella Ballerini

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

Dawn Lundin

Compliance Director
Perelman School of Medicine, University of Pennsylvania

Wendy Trimboli

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

Stephanie Viscomi

Associate Director, TMF Operations
Alexion Pharmaceuticals

Barbara Novak

Associate Director, Systems & Process Management, Clinical Operations
Kyowa Kirin, Inc.

Sahana Simon

Team Lead, TMF Operations
Alimentiv

Maria Palombini

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

Joanne Malia

Director, Clinical Documentation Management
Regeneron

Amy Lounsbury

Research Director
MNGI Digestive Health

Ronla Prince

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

Anusha Rameshbabu

Trial Master File Process Specialist
Alexion Pharmaceuticals

Dawn Niccum

Sr. Director, QA and Compliance
Inseption Group

Karen Roy

Chief Strategy Officer
Phlexglobal

Aaron Grant

VP Solutions Consulting
Phlexglobal

Marion Mays

Vice President, Expert Services and Consulting Solutions
Phlexglobal

Sharon Ames

Director Client Solutions
Phlexglobal

Stephanie Mayew

Sr Manager of Clinical Operations
PRA

Jim Markley

Project Lead
Just in Time GC

Mallorie Sayre

Manager, eTMF
Moderna