Ruby Lin Email & Phone Number

Primary Roles • Project Manager, PMP Certified• Functional Solution Architect• Lead Business consultant• System validation specialist Primary Technologies • Oracle Life Sciences Data Hub (LSH)• Oracle Data Management Workbench (DMW)• Oracle Clinical Development Analytics (CDA)• Informatica • SAP Power Designer• Oracle Clinical, Oracle Clinical RDC• JReview• SAS• Siebel Clinical• Adverse Event Reporting System (caAERS), Clinical Trial Participant Registry (C3PR), Cancer Data Standard Registry (caDSR), • Medidata Rave• Argus • ClinicalOne

Lead NCI CBIIT Clinical Application Support Group to support NCI CBITT programs including C3D adaptation, system Integration, maintenance, upgrade, migration, validation and training. Support all NCI Center Cancer Research (CCR) clinical trials with electronic data capture, system integration, reporting and data analysis, and regulatory submission.Selected Accomplishments:• Lead and manage multiple cancer research institutes adaptation of cancer Biomedical Informatics Grid (caBIG) Cancer Central Clinical Database (C3D) based on Oracle Clinical/RDC.• Design, Test, and Built Rapid Qualify Reporting System (RQRS) database for NCI Community Cancer Center Program (NCCCP) to facilitate monitoring of the quality of cancer care.• Plan, manage, and execute CBITT clinical system upgrade projects.• Provide SME support for Lab Viewer, caAERS and c3PR integration projects.• Earned Terpsys Shell Excellence Award 2009.

Managed Pharmaceutical consulting team, and oversaw system implementation projects for pharmaceutical, biotechnology, medical device company and contract research organizations (CRO) from $1M up to $5M. Provided support for project sales team and responses to all Oracle Clinical/RDC/TMS related Request for Proposal (RFPs). Selected Accomplishments: • Developed and delivered validation process flows, SOPs and guidelines for Oracle Pharmaceutical Application Development Team. Designed integrated process for testing, validation, strategy planning and communication for the organization.• Developed and delivered Oracle Pharmaceutical Application Validation methodology and Validation packages for OC/RDC/TMS.• Directed system extension and integration such as page tracking system, imaging system interface, study design API, data migration tools, and user account management tools.• Developed new services offerings, products and programs.• Started Oracle Clinical and Remote Data Capture systems from scratch. Responsibilities included managing programmers, defining processes and handling study setup, writing reports, designing and managing associated programs such as coding, OC setup, testing new versions of OC and RDC, and administration of OC accounts.

Master Of Business Administration (Mba)

Ma, Biostatistics

Bachelor Of Science (Bs), Applied Mathematics

Master Of Art - Biostastics, Biostatistics

Master Of Business Administration - Mba, Entrepreneurship/Entrepreneurial Studies