Sharon Lawlor, M.B.A.
Responsibilities & Activities
My responsibilities include clinical research support for extramural NIDDK clinical studies and trials relative to the project life cycle, beginning with protocol design through study close-out, to support best practices and adherence to NIH and HHS human subjects research policies.
I also serve as the liaison between large multi-center clinical studies funded through cooperative agreements and the NIDDK Central Data Repository and Biorepository. In this role, I work with projects to provide guidance and facilitate adherence to NIH and NIDDK sample and data sharing policies.
Prior to joining the NIDDK in February 2017, I was Director of Data Management at the Epidemiology Data Center, Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh. In that position, I advanced a data management infrastructure and established a system development team to facilitate smooth and timely startup of NIH and industry funded clinical research studies, maintain high standards in regard to data quality, and guide and support the conduct of multi-center clinical studies. I led Data Coordinating Center teams to develop best practices models to promote and monitor recruitment, retention, adherence to protocol, safety, data quality, and overall conduct of clinical studies in accordance with ICH Good Clinical Practice Guidelines and HHS and NIH human research subject policies. I also developed training materials and led training sessions for clinical site and core laboratory personnel relative to study protocols.
Committees & Working Groups
- Biomedical Informatics Coordinating Committee (NIH), Member
- Clinical Studies Working Group, Member
- Clinical Trials Operations Working Group (NIH), Member
- Data Science and Data Management Working Group (NIDDK), Member
Director of Data Management, Epidemiology Data Center, Graduate School of Public Health, University of Pittsburgh, 1999-2016