Advisory Board

Following the announcement that the Global TMF Summit will take place virtually on November 2–6, members of our esteemed Advisory Board kindly assembled to discuss the world we now find ourselves in and the important insights, content, themes, and subjects they feel important to be included in the program.

Some of the key takeaways include:

  • Address the contemporaneous and completeness of your TMF to ensure inspection preparedness
  • Review proper validations, system upgrades, audit trail reviews, and systems support
  • Build a strong quality plan to ensure the health of your TMF
  • Discuss regulatory updates and the impact of COVID-19 on records management
  • Use disruptive technologies to improve efficiency, Quality, and metrics reporting

Meet the 2020 Advisory Board Members

Astrid Beriaux, Head Trial Master File (TMF), GSK

Astrid Beriaux
GSK
Head Trial Master File (TMF)
Priya Chaturvedi, VP, Clinical Quality Assurance, Eisai

Priya Chaturvedi
Eisai
VP, Clinical Quality Assurance
Kathie Clark, Product Director, CTMS and eTMF, Ennov

Kathie Clark
Ennov
Product Director, CTMS and eTMF
Grace Crawford, Global Head, Clinical Quality & Compliance, AstraZeneca

Grace Crawford
AstraZeneca
Global Head, Clinical Quality & Compliance
Donna Dorozinsky, President & CEO, Just in Time GCP

Donna Dorozinsky
Just in Time GCP
President & CEO
Sholeh Ehdaivand, Founder and CEO, LMK Clinical Research Consulting

Sholeh Ehdaivand
LMK Clinical Research Consulting
Founder and CEO
Tim Galvin, Director of Product Management, Medidata

Tim Galvin
Medidata
Director of Product Management
Lucy Hampshire, Senior Director, Medicines Quality, Eli Lilly and Company

Lucy Hampshire
Eli Lilly and Company
Senior Director, Medicines Quality
Wendy Koc, Associate Director R&D Quality & Compliance, Gilead

Wendy Koc
Gilead
Associate Director R&D Quality & Compliance
Tim Kroboth, Associate Director, Content Management, IQVIA

Tim Kroboth
IQVIA
Associate Director, Content Management
Christa Lewiski, Study File Manager (TMF Head), Seqirus

Christa Lewiski
Seqirus
Study File Manager (TMF Head)
Joanne Malia, Director, Clinical Documentation Management, Regeneron Pharmaceuticals, Inc.

Joanne Malia
Regeneron Pharmaceuticals, Inc.
Director, Clinical Documentation Management
Barbara Novak, Systems and Process Management Lead, Clinical Operations, Kyowa Kirin, Inc.

Barbara Novak
Kyowa Kirin, Inc.
Systems and Process Management Lead, Clinical Operations
Marie-Christine Poisson-Carvajal, Head of TMF & Registry, Pfizer

Marie-Christine Poisson-Carvajal
Pfizer
Head of TMF & Registry
Lori Ridge, Senior Trial Master File Project Manager, Global Clinical Operations, Mylan

Lori Ridge
Mylan
Senior Trial Master File Project Manager, Global Clinical Operations
Emily Roberts-Thomson, Vice President of Clinical Operations, Treadwell Therapeutics, Inc

Emily Roberts-Thomson
Treadwell Therapeutics, Inc
Vice President of Clinical Operations
Karen Roy, Chief Strategy Officer, Phlexglobal

Karen Roy
Phlexglobal
Chief Strategy Officer
Pawel Rucki, Senior Manager, TMF Operations, GW Pharmaceuticals plc

Pawel Rucki
GW Pharmaceuticals plc
Senior Manager, TMF Operations
Vittoria Sparacio, Senior Director & Head, Clinical Documentation Operations, GSK

Vittoria Sparacio
GSK
Senior Director & Head, Clinical Documentation Operations
Jamie Marie Toth, CPM, MS, Director, Head of TMF Operations, Clinical Development Operations, Daiichi Sankyo, Inc.

Jamie Marie Toth, CPM, MS
Daiichi Sankyo, Inc.
Director, Head of TMF Operations
Stephanie Viscomi, Associate Director, TMF Operations, Alexion Pharmaceuticals, Inc.

Stephanie Viscomi
Alexion Pharmaceuticals, Inc.
Associate Director, TMF Operations
Courtney Wells, Vice President Clinical Operations, Avadel Pharmaceuticals

Courtney Wells
Avadel Pharmaceuticals
Vice President Clinical Operations