Manager Clinical Data Management @ • Coordinates priorities and workload assignments for clinical data coordinators • Responsible for hiring, training and managing performance of staff • Vendor management, including invoice review and approval, budget management • Serves as subject matter expert on Case Report Form Processing, database archival and management of potentially unmasking data • Supports department process improvement initiatives • Responsible for assigning proper training to study team members, including site personnel • Supports study start-up activities such as database testing, Case Report Form Design. • Responsible for successful archival of EDC studies, including site data distribution. • Manages potentially unmasking database, including generating data clarification form and reports • Manages Case Report Form design process From December 2010 to Present (5 years 1 month) Data Operations Manager @ • Manages all activities of data collection and processing, including scanning and indexing • Coordinates priorities and workload assignments for clinical data coordinators and data entry • Responsible for hiring, training and managing performance of staff. • Represents end-user on project teams that are responsible for selecting, validating, implementing, and maintaining systems such as CDMS and CRFTrack • Responsible for User Acceptance Testing of new software applications that support clinical data processing. • Supports department process improvement initiatives. • Responsible for requesting Electronic Data Capture Training through Phaseforward. From July 2006 to December 2010 (4 years 6 months) Senior Clinical Data Analyst @ • Provide support to assure that relevant milestones target dates are met or beaten. • Develop quality control practices within Data Management and related areas. • Facilitate the activities of all database QC/QA, including training of auditors, documentation preparation and coordination among data management project leads • Assume a lead role in scanning of all CRF in order to facilitate and streamline study data cleaning • Support medication coding for those projects that require additional assistance in support of key milestones From July 2004 to July 2006 (2 years 1 month) Project Manager 1 @ • Create and maintain standardized procedures in database creation, data entry, and discrepancy management to insure consistent and quality data management approaches for clinical studies. • Identify and train Medical Research Assistant in Study Conduct to insure successful and timely implementation of clinical research studies. • Plan and document the clinical database activities, including data entry, verification, and database lock within Clinical Data Management and Programming. • Implement new data management processed based on team development • Authored several SOPs. • Created and programmed consistency checks for clinical studies, From May 2003 to July 2004 (1 year 3 months)

Business Accounting @ CSU Los Angeles From 1984 to 1991 Dione Ruiz is skilled in: Clinical Data Management, Oracle Clinical, EDC, CRO, CDISC, Inform, GCP, Pharmaceutical Industry, CTMS, ICH-GCP, 21 CFR Part 11, SOP, Clinical Development, Data Management, Clinical Trials, Clinical Research