May 16, 2018
The webinar will run twice:
7 AM CT - 8 AM EST - 5.30 PM IST - 8 PM CST
10 AM CT - 11 AM EST - 9.30 PM IST - 11 PM CST
Data managers are often tasked with overseeing the data management activities of CROs and/or third party vendors. This is a huge responsibility and requires not only a skill set in data management; but also an understanding of project management, business management, and psychology to build and maintain a successful client/vendor relationships. Participants will learn the components of a well- defined SOW; how to apply a risk based approach to vendor oversight; learn simple project management tools for data management oversight activities; and learn how to identify and close gaps in expectations.
The webinar will cover the following learning objectives:
• Sponsor Responsibilities for Vendor Oversight according to ICH E6 R(2)
• Steps to Successful Vendor Selection
• Tools for Keeping Client/Vendor Relationships on a Successful Track
• Identify and Close Expectations Gaps
With over twenty years of experience in research computing and leading operations at CROs, Dawn Edgerton assists biopharmaceutical sponsors with CRO selection and oversight. She pays special attention to data integrity allowing the small biopharma executive to focus on the bigger picture. Dawn holds an MBA in dual concentrations of Services and BioSciences Management. She completed her Regulatory Affairs Certification in 2013. She is an active member of Society for Clinical Data Management (SCDM) and maintains membership in Pharmaceutical User’s Software Exchange (PhUSE), North Carolina Regulatory Affairs Forum (NCRAF), DIA, CDISC, and the North Carolina Council for Entrepreneurial Development.
Participants are eligible to receive CEUs upon attendance and successful completion of a web-based assessment within 30 days after the webinar. CEUs are not granted after the 30-day assesment deadline.