UNIX (HP-UX & SUN) Operating System running Oracle
International Pharmacovigilance Adverse Event System Customization Project (IPAES)
Technical Manager, IPAES phases II and III
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| | Prepare IQ/OQ documents, obtain all approval signatures, and execute on validated systems
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| | Manage database and application security
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| | Write and submit emergency database IQ/OQ documents for IPAES phase III production
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| | Work closely with ISQA Validation Specialist and Business Owner on validation documents
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| | Export, script execution, space management, and critical condition alert system development
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| | Create and validate new production Oracle database for Phase III implementation
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| | Work with UNIX SA/app developers to upgrade production validation environment
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| | Tune, troubleshoot and customize vendor-delivered reports
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| | Apply updates and patches to validated CFR-compliant versions of application
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| | Integrate several CFR-compliant legacy databases into IPAES production system
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| | DBA Projects Manager IPAES phases IV and V
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| | Coach and technical guide to team members in CFR and company standards and procedures
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| | Periodic activity review to management on IPAES tasking and interfacing methodologies
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| | Communicate critical sub-task issues among speciality teams
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| | Ensure compliance of IPAES db-related tasks with CFR validation documentation and protocols
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Oracle Clinical (OC) Application Production Roll-Out
DBA Projects Manager, OC production Ramp-Up
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| | Prepare project plans and task forecasts
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| | Mentor DBA consultant hired to work exclusively on OC project
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| | Manage database and application security
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| | Streamline CFR compliance of international change control procedures
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| | Work closely with vendor and IT Tech Team to prepare and execute validation documents
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| | Install CAVS (Computer Assisted Validation System)
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| | Determine proper interoperability and inter-compliant patch releases
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| | Ensure data integrity
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| | Support OC Production Database
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| | Guide changes on validated production to ensure Int'l Change Control Board compliance
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| | Moderate weekly team meetings to ensure request-groups were summing to project milestones
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| | Manage consultant work on project plug-ins (TRW Autocoder, IR, CAVS, et. al)
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| | Facilitate tasks needed to implement post-production modules and customization
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Manufacturing Systems Support (Validated Systems)
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| | Support electronic batch-release projects
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| | Manage CIIM Validated Legacy migration (Oracle 6.0.37 DEC-VAX to 7.3.4 HP-UX)
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| | Facilitate POMS-SAP Pharmacy Dispensing Interface
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| | Install BARCODE and CYCLETIME manufacturing material-tracking subsystems
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R&D LIMS Application DBA
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| | Create and Validate (IQ/OQ) several Oracle databases on schedule
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| | Execute numerous IQ/OQ documents for application code upgrades
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| | Improve relations with Ardsley R&D LIMS team
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| | Provide good technical guidance and database expertise
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| | Accomodate last minute users requests
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| | Provide detailed agendas and keep meetings focused on issues at hand
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| | Plan and implement archive logging for LIMS production database
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Financials Systems DBA (Oracle Financials and SAP liasion)
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| | Oracle Financials 10.7 and 11i production support
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| | Troubleshoot concurrent manager problems
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| | Facilitate and execute database-related pieces of external interfaces to other database systems
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| | Support migration of Oracle Financials to SAP Financials
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| | Install/Deploy/Post-Production Interfaces (including CFR compliant Validated sub-systems)
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| | Support IXOS-SAP Accounts Documentation System production installation (Validated I&C)
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| | Implement Vertex TAX calculation system and supervise consultant activity (I&C)
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| | Manage Capital Budgeting Interface (I)
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DBA DR Team Lead, SAP Disaster-Recovery Simulation
Daily Production database support including Validated Medical, Sales/Marketing, & Corporate
Validate install of Audrey Audit Application
Validate install of Magic Solutions Help Desk and Change Management Application
Extensive training in the HP implementation of UNIX Operating Systems
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