Lauren Gigliotti has been in the life sciences industry managing data and systems for more than 30 years for CROs as well as Pharmaceutical and Biotech firms. She started in the industry as an Oracle database developer and clinical programmer. Lauren has always taken on the most technically challenging projects she can find, as she enjoys the opportunity to stretch her skills. It is this drive that has enabled her to become one of the most uniquely experienced and talented life science professionals in the Bay Area.
Lauren developed both the Data Management team at Genomic Health and the Data Science team at Celgene from the ground up. Lauren was at the forefront of the evolution of the changing role of the Clinical Data Manager to Clinical Data Scientist in bringing Data Science to Celgene.
Lauren has significant experience with bringing CDMS/EDC systems in house as well as executing the appropriate validation of these systems. Additionally, data integrations of clinical trial data collected outside EDC systems, or legacy and real-world evidence data is a standard part of her repertoire. Lauren is also well versed in the process of the management of specimens and specimen data in the context of a clinical trial, cloud compute spaces and genomic data.
Lauren has worked extensively with oncology drug trials in all phases as well as many other drug indications and device trials. She is experienced working within CDISC standards and preparing datasets for analysis in SDTM and ADaM formats.
One of Lauren's great strengths includes the ability to work with existing teams to support process development and/or improvement. Her proven ability to listen, harmonize ideas and gain engagement and adoption from peers and leadership has enabled substantially improved and quality data workflows.
Whether you're just looking for a bit of guidance or looking to manage a project, we've got you covered. Our mantra is: analyze, identify, advise, execute. Our mission is to create relationships, not transactions. Our promise is that we'll be there, as questions or issues arise, every step of the way.