Join our Leadership Webinar Series

Society for Clinical Data Management (SCDM) > Join our Leadership Webinar Series

WEBINAR SERIES

SCDM’s Leadership Webinar Series for early 2021 features two webinars guiding you through all things CDM. They will offer many things: insightful, informative, challenging and, of course, inspiring.

The first webinar in the series is entitled “2020’s Biggest Game Changers Revealed” is a live interactive event that will allow polling and live chat, with moderators; similar to the SCDM Virtual Annual Conference plenary experience. The Annual Conference key highlights will be the basis for this inspiring webinar.

KEY TOPICS:

  • AI and ML moderated by Ian Schafer
  • Decentralized and Regulator moderated by Jonathan Andrus
  • Leadership, RBQM by Catherine Celingant

The ultimate question will be – how does the future look like beyond COVID19 and all that comes with it? How is it going to look like being part of this industry in tomorrow’s world?

Our second webinar picks up the CDM story from where the first one left off. It builds on SCDM’s successful year beginning tradition of delivering insightful intelligence as well as presenting its agenda for the coming year. Presented by SCDM’s Chair for 2021, Sanjay Bhardwaj, the webinar is entitled “So Much for the Game Changers… What’s Next for CDM?“.

Upcoming:
So Much for the Game Changers… What’s Next for CDM?

Wednesday, 3 February 2021
8:00 PST | 11:00 EST | 17:00 CET | 20:30 IST
Session Duration: 90 minutes

On February 3rd SCDM New Chair Sanjay Bhardwaj’s State of the Industry webinar will continue this discussion by sharing how SCDM intends to support its community through these changes.

Join our SCDM Chair to explore what is in store for 2021.

Speaker:

Sanjay Bhardwaj
Allergan | Global Head of Clinical Data Management

Sanjay is the Executive Director and Global Head of Data Management at Allergan – an AbbVie Company, where he is accountable for end-to-end delivery of CDM activities across all therapy areas. Previously, Sanjay held several strategic and operational roles in the industry with increasing responsibilities and scope at Merck/MSD, Novartis, and Biogen. With 24 years in clinical data and technologies space, Sanjay is passionate about clinical research, organizational leadership, and building high-performing teams. He was elected as the Vice-Chair of the Board at SCDM in 2020 and now takes on the role of Chair of the Board for 2021. Sanjay brings industry thought-leadership to the society through its Innovation committee and publications- most recently as one of the co-authors of “Evolution of Clinical Data Management to Clinical Data Science” series of reflection papers published by SCDM Innovation committee. Sanjay is based in the US… and a proud father of 2 high-schoolers and enjoys playing/watching cricket.

Past Webinar:
2020’S Biggest Game Changers Revealed

Thursday, 21 January 2021
7:00 PST | 10:00 EST | 16:00 CET | 19:30 IST
Session Duration: 90 minutes

2020 was a year like no other for the CDM industry. The last 12 months have seen an unprecedented amount of disruption made even more significant by the Coronavirus pandemic. However, if the past year has taught us something, it is that we must always challenge the status quo, we must experiment and we must seek to thrive in the face of adversity. For the CDM industry, 2020 was a year in which we achieved all of these – and a whole lot more.

Join industry leaders in an insightful conversation as to how the industry’s accomplishments and SCDM’s work has shaped the future of our sector.

Speakers:

Catherine Celingant
Pfizer | Executive Director | Data Monitoring & Management, Oncology TA Lead

As the Oncology Therapeutic Area Lead in the Data Monitoring and Management (DMM) organization at Pfizer, Catherine Célingant leads a team of Clinical Data Scientists and Data Managers responsible for timely and high-quality data management deliverables supporting the Pfizer Oncology portfolio. Catherine has over 25 years of experience in Data Management, Clinical Informatics, and Medical Operations. Prior to joining Pfizer, Catherine worked at Millennium: The Takeda Oncology Company, where she successively led the Clinical Data Management and Clinical Systems, Medical Systems Innovative Technologies and Operations, and Medical Business Operations functions. Catherine also worked at Accenture, Wyeth, Genetics Institute, and MTRA (AAI). Over the years, Catherine has been involved in several PhRMA, eClinical Forum and Transcelerate-sponsored groups working with other bio-pharmaceutical sponsors, regulators and other stakeholders to facilitate the adoption of research-enabling technologies such as EDC, ePRO, and eSource. Catherine holds a M.A. in Linguistics from Cornell University and an undergraduate degree in Biology from the University of Bordeaux, France.

Ian Shafer
PwC | Partner

Ian Shafer is a Partner in PwC’s Pharmaceutical Advisory Practice and has been working in the BioPharmaceutical industry focused on Clinical Development for the past eighteen years. Ian joined PwC in 2019 and is focusing on global clinical development business transformation enabled by digital technologies. Previous to PwC, Ian led the Clinical Domain within Accenture’s R&D practice, was one of the initial Medidata employees, and held multiple roles within Amgen’s clinical development organization. Ian’s project experience includes business strategy/roadmap development, operating model design, business case development, global digital business transformation, technology selection and implementation, emerging technologies and advanced analytics, business process optimization, change management, and SDLC management. Ian’s functional focus spanned program/protocol design, study start-up, clinical trial operations, data management, analysis and reporting, and submissions and has led 50+ major transformational programs during his career. Ian received bachelor’s in molecular, Cellular, and Developmental Biology from the University of California, Santa Cruz in 1999.

Jonathan Andrus
Clinical Ink | Chief Business Officer

As Chief Business Officer, Jonathan Andrus leads Clinical Ink’s solution management & compliance teams to help sponsors and CROs better leverage eSource, eCOA and ePRO data. With 20+ years of experience, Mr. Andrus brings extensive expertise developing eClinical services that integrate data and technology to help life science companies optimize study execution. At Clinical Ink, Mr. Andrus is responsible for P&L across Clinical Ink’s products and services and he is also focused on building relationships and forging strategic partnerships with sponsors, CROs, regulatory bodies and clinical research professionals. Mr. Andrus joined Clinical Ink from BioClinica where he led the eClinical Solutions Group to develop their current service offerings, including data management, quality management, implementation services and IWRS. Prior to BioClinica, Mr. Andrus worked in pharmaceutical consulting and with CROs focused on quality, data management and validation. An active thought leader, blogger and presenter, Jonathan served as chair of the Society for Clinical Data Management (SCDM) in 2008 and 2013 and currently serves as the society’s Treasurer. He is also an active member of DIA (North American Advisory Council and Annual Conference Data/Data Standards Track Chair) and ASQ. He earned his bachelor’s and master’s degrees from Temple University’s College of Liberal Arts and Graduate School of Pharmacy and is a Certified Quality Auditor (CQA) and Certified Clinical Data Manager (CCDM®).

Michael Goedde
PRA Health Sciences | VP, Global Data Operations

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 3+ years and led a global group of 850 CDMs, DB-Programmers and Statistical Programmers. Michael joined PRA Health Sciences in 2018 as Head of Global Data Operations. Michael holds a degree in Computer Sciences and Mathematics and is the current Chair of the Board of Trustees for the Society for Clinical Data Management (SCDM). 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.

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