PI Signatures: when Should They Sign and how Often?

Dan has been in the pharmaceutical industry for more than 25 years in both large Pharma and CROs. He spent fifteen years in Data Management where he managed or had oversight on more than 325 clinical trials. He has provided training and consulting to organizations on the implementation of data standards and submission of NDA/BLA to the FDA. He’s a core team member of CDASH and Expanded Leadership Team. He currently serves as the Chairman of CDISC Advisory Council. He actively participates in authoring and presenting educational materials to the industry. In his current role at Veeva, he’s responsible for helping customers implement Veeva EDC, CDB and create processes and best practices.

Dawn has over 25 years of experience in the pharmaceutical industry. She have worked within every level of clinical data management, from Data Coordinator to Senior Director where she participated in or had oversight for more than 250 clinical trials.

During her time in the industry, she has provided consultation to organizations on clinical trial conduct, best practices in Data Management and data capture as well as developed standardized libraries and templates to support the adoption of CDISC standards. She is an active member of SCDM as a GCDMP SME, course designer and webinar presenter as well as former Co-Chair of the annual conference (2018-2021) and currently serves on the SCDM Board of Trustees. Dawn is involved as a member of the CDISC-CDASH core team, Diabetes sub-team, CDASH CFAST Expanded Leadership Team and former Co-Chair of the CRF Library project.

Dawn currently holds the position of Vice President, BD Operations, where she supports business development as a Clinical Subject Matter Expert for both software and Biometrics services as well as overseeing the Proposals and Solution Consulting departments.

As the Sr. Director of Security, Corporate QA and Compliance, Marc is leading the corporate security, quality and compliance initiatives at CRIO. Additionally, he’s serving as CRIO’s Data Protection Officer. Prior to CRIO, Marc was leading the Quality Assurance efforts at snapIoT, now part of Labcorp Drug Development. Before snapIoT, Marc was a key member of the Corporate Compliance and QA group at Clinical Ink from 2012-2021 and served as its Data Protection Officer from 2018 to 2021.

He is a frequent contributor in the regulatory and compliance space and has participated as a speaker and panelist host at the following:

SCDM India Annual Conference
SCDM Annual Conference
Society for Clinical Research Sites (SCRS) Global Site Solutions Summit
Association for Clinical Research Professionals (ACRP) Annual Conference

Ms. Olberding has been working in data management for over 20 years. She is currently the head of Operational Excellence in Global Data Managment at Merck & Co, Inc, NJ USA where she oversees process, learning and compliance for 2900 data management employees across the globe. She has extensive experience in project management, risk management, continuous improvement, privacy, and compliance. She is the data management process owner. Megan has also supported numerous global health authority GCP inspections.