[ 29/09/2023 by SupportHT 0 Comments ]

Maria Craze

Maria Craze

Company

Executive Director, Global Data Operations at Merck & Company, Inc

Personal Information

Maria Craze is an Executive Director, Global Data Management & Standards at Merck & Co. Maria has 20+ years of experience in the Pharma Industry, specifically in clinical data management. She has held varying positions from hands on data manager, trainer,  project manager, operations leader to people manager.  Maria has also been an active member of SCDM for over a decade, participating as a volunteer, conference chairperson and presenter, and a SCDM Board member for 5 years, serving on the Executive Committee as the Secretary in 2022.

[ 29/09/2023 by SupportHT 0 Comments ]

Reza Rostami

Reza Rostami

Company

SCDM Board of Trustee Member, Director, Quality Management, Duke Clinical Research Institute

Personal Information

Mr. Rostami has 26 years of experience in the field of clinical data operations, clinical informatics, quality management, risk management, and regulatory compliance. He has received Biomedical Engineering and MBA degrees from Duke University. He is also certified as a Clinical Data Manager, Six Sigma Black Belt, Quality Management, Quality Engineer, Quality Auditor, and Regulatory Affairs. Mr. Rostami has been speaker and session chair in conferences (SCM, DIA, SCT, CHI, ACS, PEA, TRI, ISGCRT, JSCTR) in US, Canada, Europe, and Japan in the past two decades.

[ 29/09/2023 by SupportHT 0 Comments ]

Ward Lemaire

Ward Lemaire

Company

Head of Data Management, Janssen R&D

Personal Information

Ward Lemaire is the Head of Data Management Janssen R&D, accountable for all DM deliverables in the Janssen R&D portfolio and defines and shapes the Data Management Strategy.

Ward holds a master’s degree in Cell and Gene Biotechnology and a bachelor’s degree in Applied Biological sciences and is in the industry for +19 years.

Ward has lived in 3 continents; originally from Belgium but has also lived and worked out of China and now located in the US for the last 7 years out of Springhouse, PA. In his free time, Ward coaches basketball and loves spending quality time with his family.

[ 25/08/2023 by SupportHT 0 Comments ]

Michael Goedde

Michael Goedde

Company

VP, Global Data Operations, ICON plc

Personal Information

Michael Goedde is a Certified Clinical Data Manager with 30+ years of experience in the pharmaceutical and biotechnology industry.He started his career in 1990 at Hoechst, a predecessor company of Sanofi, in Frankfurt (Germany). After supporting numerous submissions and leading programs through all stages of clinical development, Michael then chose to join the Aventis Headquarters in Bridgewater, New Jersey (US) in 2001 as a Global Project Data Manager and Global Therapeutic Area Lead for Oncology and Neurology.

After leaving Sanofi-Aventis in 2005 he joined Kos Pharmaceuticals in Florida for 2 years before accepting the position of Senior Director of Clinical Data Management at Human Genome Sciences (HGS) in Rockville, Maryland. After the GSK takeover of HGS in 2012, he joined MedImmune(Astra Zeneca) as Head of CDM, where he re-built the CDM department. In 2014 he decided to join PAREXEL International as VP, Global Data Operations, where he worked for 4 years and led a global group of 850 CDMs, DB-Programmers and Statistical Programmers. Michael joined PRA Health Sciences (now ICON) in 2018 as Head of Global Data Operations and held this position until 9/2023. Michael holds a degree in Computer Sciences and Mathematics and served on the Board of Trustees for the Society for Clinical Data Management (SCDM) from 2017-2021.

He has presented and chaired sessions on numerous occasions at conferences including an invitation from the FDA in 2010 to present on “Industry Best CDM Practices” at the Center’s Bioresearch Monitoring course.

[ 25/08/2023 by SupportHT 0 Comments ]

Jennifer Price

Jennifer Price

Company

Leading Data & Analytics Strategies, THREAD

Personal Information

Jennifer is an accomplished professional with 25+ years of clinical research management and technology implementation experience. Jennifer has proven success with strategic planning, project management, data management, quality and risk based systems, within many therapeutic areas in Clinical Research. Jennifer is a passionate advocate for eSource, Clinical Data Standards, Clinical Data Sciences, Direct-to-Patient technologies and Direct Data Capture.

Jennifer is a past Board Member and Secretary of the Society of Clinical Data Management (SCDM) 2015-2020 and currently heads the Data Strategies group at THREAD.

[ 25/08/2023 by SupportHT 0 Comments ]

Patrick Nadolny

Patrick Nadolny

Company

Global Head, Clinical Data Management, Sanofi

Personal Information

Mr. Nadolny has over 30 years of industry experience across pharmaceutical, device and biologics as well as technology solution development.

Mr. Nadolny is a pragmatic leader focusing on technology, innovation, strategic planning, change management, and the setup of new capabilities. Mr. Nadolny is the Global head of Clinical Data Management at Sanofi.

In addition to being the Vice Chair of the SCDM board, he led the SCDM innovation committee from 2018 to 2022 which released many papers on the evolution of Clinical Data Management toward Clinical Data Science.

[ 19/12/2022 by SupportHT 0 Comments ]

Stephen Cameron

Stephen Cameron

Company

Director, Clinical Data Management, ICON

Personal Information

Twenty-five years of biotechnology, microbiology and clinical trial data management.  Areas of focus include recombinant, subunit, attenuated and whole cell bacterin and viral vaccines, cellular therapy, oncology, gout and biosimilar studies as well as monoclonal therapies.  Significant exposure to global team leadership, project management and data operations functional management support for local and global team members, including clinical data coordinators, clinical data scientist leads and functional managers.  Active member of Society of Clinical Data Management, working as conference co-chair for 2020 through 2023 annual general meetings as well as board of trustees member 2022 through 2024 working as academic committee liaison.