Sharon Lawlor, M.B.A.
- Clinical Trials Program Specialist: Office of Clinical Research Support
- Clinical Trials Program Specialist: NIDDK Central Repository
Responsibilities & Activities
As a member of the Office of Clinical Research Support (OCRS), I coordinate activities across the disciplines to support best practices and adherence to NIH and HHS human subjects research policies throughout the project life cycle.
I also participate in data science related activities and as a member of the NIDDK Central Repository leadership team to align NIDDK activities with the NIH and NIDDK strategic plans for data science and research specific to advancing the biomedical data science ecosystem, improving FAIR-ness of resources generated by NIH-funded projects, and improving adherence to NIH and NIDDK resource 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 regarding 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
- Common Data Elements Task Force (NIH), Member
- Clinical Studies Working Group, Member
- Clinical Trials Operations Working Group (NIH), Member
- Data Science and Data Management Working Group (NIDDK), Member
- NIDDK Central Repository Executive Committee, Member
Director of Data Management, Epidemiology Data Center, Graduate School of Public Health, University of Pittsburgh, 1999-2016