Sam Morley Email & Phone Number

Oversaw the design, development and implementation of specialized databases, tools and applications to support clinical and translational research at UC Davis and acted as a representative to the national consortium of CTSA award recipients to develop resources to benefit all represented CTSA institutions. Helped facilitate the use of novel information technology and computing methods to assist Investigators in managing and evaluating the clinical data necessary to support their research program. Worked closely with the Biomedical Informatics program director to help investigators make the most efficient use of informatics services and resources.

Medical device development/ Mission critical software development/ Clinical data management/ QA documentation and testing/ FDA submission experience

Managed projects ranging from software I developed for downloading text data from the GlucoWatch® (a noninvasive meter for diabetics), LIMS systems for organizing and maintaining laboratory data, Analyst software for acquiring raw data from Mass Spec machines, to document management systems for organizing and protecting business critical documents.Clinical trial and CRO experience: As a CRO IT Manager I maintained compliance with FDA regulations and internal SOPs. Acted as Cygnus company spokesperson and CRA during clinical trials on GlucoWatch® testing for temperature deviations. Monitored data management issues with CRO in charge of Cygnus clinical data. Worked with Gore and St. Jude on surgical clinical studies on aortic grafts and left ventricular assist device.Developed mission critical software: Conceived, created, and validated software that was mission critical for clinical trials of the GlucoWatch®. Developed Software that saved the company millions of dollars by minimizing lost data due to device synchronization problems. Developed GUI interface to replicate paper forms used in clinical trials. Program was used to enter data directly into clinical database.

As Validation Compliance Manger and Pharma IT Manager my responsibilities include maintenance of all software and hardware systems in a state of compliance with federal regulations (FDA 21 CFR part 11 and 58 -GLP). This includes validation documentation for "off the shelf" as well as "in-house" custom software.Performed validation on key lab software used for revenue generating data stream.Wrote and maintained all IT computer system documentation and SOPs.Wrote and maintained the IT Disaster Recovery Plan.Implemented a digital signature solution to move company towards a "paperless" system.Introduced, validated, and began implementing a document management system to the lab. Software packages utilized; CoSign (digital signature application), Adobe 8 and LiveCycle Designer (document and form development), REES (environmental monitoring software), Robo Help and MadCap software (help file development), SharePoint (portal software), Analyst 1.4.2 (mass spectrometer software), ALIS ('in-house" LIMS system), and Watson 7.4 (3rd party off the shelf LIMS software)Consulting, October 2004 to 2006Contract work developing an Access database system for the State of California court's Mediation program.Partner in a startup company selling the Portal Pulse metrics software tool to collect data on how companies utilize

Worked in research and development as Engineer III creating a non-invasive glucose monitoring watch for diabetics Glucowatch Biographer*. Managed project to investigate temperature and sweat effects on the watch signal. Assisted in algorithm development for the Glucowatch*. Managed database throughout clinical trials. Managed project for in-house software development using Access, VBA, VB6.Developed VB GUI interface for watch download and watch simulation programs. Developed a stand-alone, mission critical program for text capture from the GlucoWatch Biographer. Assisted in setting up the Oracle clinical database and table structure. Managed documentation for software development from development through design/validation and installation. Acted as company CRA (Clinical Research Assistant) on site at clinical test sites and CRO. Adhered to FDA regulations 21CFR part 11 for all software developed for clinical trials.Adhered to cGMP, cGLP and ISO techniques, documentation, validation, and hypothesis testing.

Ms, Biomedical Engineering

Bs, Biology