SUMMARY

More than 12 years of extensive experience managing globally hosted enterprise applications and Oracle databases in a regulated environment. Oracle Certified Professional Database Administrator, experienced in database administration, performance tuning, PL/SQL development, ETL, Business Intelligence and data reporting, and database risks and protection planning. PMI Certified Project Management Professional (PMP), with extensive project and business analysis experience in system planning, requirement management, application management, business process development, SOP development, system validation, risk analysis, and change management.

TECHNICAL QUALIFICATIONS

Certifications: Oracle Certified DBA, PMI Certified PMP
Clinical Systems: Oracle Clinical/RDC, TMS, Clintrial, InForm, eLoader, AERS, Argus, LS Data HUB, IMPACT, Siebel Clinical, JReview, SAS, CRFTrack, Data Flow Manager
Databases Supported: Oracle (8, 9i, 10g, 11g), Microsoft SQL Server, MYSQL, and NOSQL (MongoDB)
Domain Knowledge: Clinical Data Management, Pharmacovigilance, SAE Reporting, Clinical Trial Mgmt, PL/SQL Development, ETL, Data Modeling, System Validation
Languages: SQL, PL/SQL, T-SQL, Java, SOA, XML, XLST, UNIX Shell, HTML, Perl, and Python
Reporting: OBIEE (Oracle Business Intelligence), CRYSTAL REPORTS
Additional: FDA 21 CFR Parts (11, 320, 32), IND, NDA, GCP, CDISC, SDTM, AGILE, WHODD, MEDDRA, SQL Developer, Toad, and Bioinformatics

WORK HISTORY
Principal Consultant – Confidential, (Jan 2012 – Present)
Oracle Clinical Custom Development [Development Environment]

• Develop various CDM Operational reports using Oracle Business Intelligence (OBIEE) Publisher to track study performance in Oracle Clinical.
• Develop PL/SQL package for managing Oracle Clinical VPD (Virtual Private Database)
• Developed a service for automating site setups in Oracle Clinical. Develop PL/SQL package for creating production and test study sites. Developed a service composite to bind the PL/SQL package as a web service using Oracle SOA suite.

Oracle Clinical 4.6, Argus, LS Data Hub, and Oracle EBS 12 [Development Environment]

• Created development environment for Oracle Clinical 4.6, Argus, Life Science Data Hub, Oracle EBS 12, OBIEE 11g, SOA Suite 10g, and Oracle Identity Management Suite 11g.

PROFESSIONAL EXPERIENCE
Application Administrator/Consultant – Confidential, (Aug 2010 – Dec 2011)

• Responsible for managing user accounts for Oracle Clinical RDC system.
• Responsible for troubleshooting issues with Oracle Clinical RDC, TMS, CRFTrack, and Data Flow Manager.
• Developed various SQL reports from Oracle Clinical and CRF Track to validate initial release of reports for Data Flow Manager
• Customized Oracle Clinical DCF report to enhance end-user usability
• Developed various operational and compliance reports using SQL scripts.
• Assisted with troubleshoot issues with eLoader performance.
• Developed a comprehensive database security plan to both control levels of access and to protect sensitivity clinical trial data from internal and external partners.
• Developed a strategy for a Back-End Data Security mechanism using Oracle VPD (Virtual Private Database) to control, segment, and audit access of data for users with direct access to the backend database.
• Developed an installation plan, a data blinding strategy, and a draft SLA for Oracle Clinical 4.6
• Installed Oracle Clinical 4.6 in a development environment, using Oracle 11g, Oracle App Server 10g, and Oracle Reports Server
• Developed a strategy for user access management

Application Manager – Confidential, (Sep 2005 – Jun 2010)

• Responsible for managing 8 global enterprise wide CDM application, which included Oracle Clinical (OC) RDC, TMS (CODING Tool), Clintrial, Clintrace, CRF Workflow, eLoader, CLINT (SAE Reconciliation Tool), and eNotifi (SAE Notification Alert System).
• Responsible for managing global user access (for more than 10,000 users), troubleshooting technical issues, and documenting bug fixes or workarounds.
• Responsible for developing various custom SQL reports to operational and performance reporting (Missing Pages, AE/SAE Listings, Patient Listings, Open Discrepancies, Un-Authorized Access, Site Listings, Coding reports, and Performance Completion etc.)
• Developed various PL/SQL packages and SQL scripts to automate ETL tasks
• Assist with the loading of WHODD and MEDDRA Coding Dictionaries
• Responsible for troubleshooting technical or performance issues with edit check and validation PL/SQL programs, custom Data Extract Views, CRFs, and LAB loading procedures
• Performed Database Locks, Interim Locks, and Data Freezes
• Responsible for developing application admin plans, user access mgmt plans, SOPs, business continuity plans, ITIL based service documents, and end-user training material.
• Responsible for documenting enhancement requests, managing the change control process, performing impact risk assessments, and performing security and compliance audits.
• Member of several international projects and production teams to perform system implementations, validations, enhancement planning, and change management.
• Assisted QA team to develop compliance tests, vendor specifications, and to review SLA documents for outsourcing vendors
• Worked with SAS developers to validate SAS/AF applications and build listings.
• Work with international team to implement Oracle Identity Management (OIM); responsible for defining requirements, functional specs; responsible for defining resources, resource groups, and workflows for user account provisioning; developed documentation and performed system validation

Project Management Consultant – Confidential, (Jul 2003 – Aug 2005)

• Worked with International project team to implement a CRF document imaging system and several ancillary CLINTRIAL (SAS/AF) applications.
• Performed various business analyst tasks such as reviewing requirements, developing functional specs, developing detail design documents, and developing OQ validation (testing) documents.
• Managed OQ validation testing team
• Developed business process documents and developed end-user training material

Database Administrator - Confidential, (Jan 2001 – Feb 2003)

• Responsible for managing the growth of 12 Oracle databases and 4 Microsoft SQL Server databases. Monitored database performance, system logs, and database security
• Managed the database backup process using RMAN
• Responsible for managing the hosted METATRIAL EDC application, which entailed managing over 1000 users, troubleshooting technical issues and level 3 helpdesk tickets.
• Developed various operational and client usage reports using PL/SQL, HTML
• Performed various ETL tasks for loading lab data using SQL Loader, PL/SQL, and shell scripts
• Developed various SOPS to document security procedures and operational processes
• Assisted development team with performance testing and security code reviews.

Reports Developer – Confidential, (Feb 2000 – Nov 2000)

• Developed various operational and performance analytics reports Medical Claims Processing, using Crystal Reports and SQL Server
• Developed various SQL scripts, Views, and T-SQL procedures for ETL tasks and for generating dimensions views for reporting
• Perform Database Backups

Programmer Analyst – Confidential, (Oct 1992 – Nov 1999)

• Performed requirements analysis for DOD Medical Records System
• Performed Mainframe COBOL Testing for Y2k Projects for DC Superior Court and Maryland Comptroller of the Treasury

EDUCATION
Masters of Science in Computer Science