SUMMARY:

• Senior IT professional with near 10 years of IT experience with expertise in administrating Healthcare & Life Sciences compliance tools such as Confidential EQMS, SAS administration (Healthcare) and SAS BI products Administration on UNIX/LINUX/Solaris and WINDOWS platforms. Worked on AMS module of Confidential on enhancements, which included adding organizations to the system, updating to the latest Confidential system (From 8.3 to 8.4.1 and then to 8.4.2).
• Worked on creating connections between SQL databases and Confidential application (AMS and R&D CAPA) during application enhancements with Sparta Systems.
• Created a new Centre of Excellence for Confidential to implement User Training environments for Confidential EQMS and presented the functionalities to 500+ users.
• Worked with Sparta System (Vendor) to Implement R&D CAPA module for Confidential for additional Organizations across Confidential .
• Worked on Risk Governance and Compliance modules in Business Wise infrastructure to implement the changes as per Confidential Requirements. Developed a separate WebAdmin portlet ( Confidential ) for Confidential to create Records, Audits and CRS for both internal and external auditing.
• Conducted Workshops on Audit Management System and R&D CAPA modules of Confidential across different organizations in Confidential globally. Provided Training to 500+ user base on the system and its functionalities.
• Trained R&D and Infrastructure teams including DBA’s and Admins on Confidential EQMS on implementation and configurations.
• Created a Training environment for hands on practise with dummy systems.
• Worked on implementing functional Changes to Global Risk and Compliance System for financial Auditing in Confidential .
• Conducted Training sessions on GRCC modules for different support team across Confidential .
• Worked in installing the complete Confidential framework including the application, Oracle 11g client, databases (Development, Test, Production and Training), Reporting servers to make a connection with Confidential WebAdmin and reporting tools to generate reports. Worked on updating the dedicated AMS ( Confidential ) servers to windows server 2008. The main work included the installation of AMS modules, migrating the installation files (dll’s), migrating reports, installation of Oracle components, Configuring Databases and filers to give access to files and folders on Confidential Servers.
• Created 800+ users in R&D CAPA organization lists from LDAP and provided BPO, Exception Manager, Power User and Viewer roles to the organizations.
• Worked on AMS (Audit Management System) server monitoring for Development, Test, Production and Sandbox environments for Disk occupancy and storage. Worked on data migration model from Dev to Test and to Production/Training environments using Confidential PR import utility tool and AMD migration Utility tools via AMS WebAdmin.
• Worked on generating reports on records from AMD WebAdmin utility (Crystal Reports) and helped to create snapshots of the data on the filers. Worked on records creations, editions and changing the status from pending locked to other status using flat files.
• Worked on Change, Problem and Incident Management for AMS and CAPA enhancements and to capture the changes in Confidential related SOP’s.
• Supported Clinical Data Analysis for GBDS, CfOR and CDM Systems using SAS EG. Create Datasets for CDM group using SAS 9.x on windows and Unix platforms. Supported CDM2SAS, SAS - SDF platforms for Clinical Data Management group including the programmers.
• General product installation and support of Base SAS, SAS Enterprise Guide, SAS Enterprise Miner, Add in Microsoft office, Text Miner, SAS Activity Based Management, SAS JMP, SAS Data Integration Studio, SAS Information map studio, SPDS server, SAS IT Resource Management, SAS Management Console, SAS Web Report Studio, as well as other SAS tools that may be evaluated. Duties include planning, coordinating, installing, migrating and implementing new releases and system enhancements, upgrades, testing and evaluation of new SAS products. Testing new releases/hot fixes/service packs, installing and tuning the product. Usage of SAS Management Console (SMC) for setting up users, groups, access permissions, metadata access, database connections, registering stored processes, information maps, foundation and custom repositories, web reports, OLAP cubes, Monitoring SAS system performance, including individual processes, overall disk, CPU, Memory usage utilization and ability to assess growth and plan required upgrades.
• Effectively use UNIX shell scripts for programs and procedures in place. Setting up Spawner’s (object, connect), servers (metadata, shared, stored process, OLAP,) and making sure to keep them up and running.
• Configuring SAS post install for setting up DB connections to enable data flow for users.
• Ensure that system controls are in place to meet change management & compliance requirements. Identifying potential issues, working with vendors and provide research and solution recommendations proactively
• Writing and executing effective test plans to ensure quality and stability, and ensuring system documentation is complete per Clients standards.
• Supported Data Fabric Hypercare project to support SAS and SAS related applications on Virtual machine.
• Provided workshop on Virtual Desktop Infrastructure working and functionality and on SAS Enterprise Guide 5.1 (end to end functionality) to a 30-35 user base.
• Setup R&D CAPA from start for Confidential offering different roles for the Client
• Setup new applications like Cytel Simulation Studio, Compass 2.0 and Quality Metrics 4.5.
• Perform Customizations and development on Confidential as per the client requirements.
• Create Custom enumerations using Confidential builder and activate the metamodel.
• Create Financial Control Transaction review templates in Confidential and to link them to old templates, migrating the templates from Development environment to the UAT/Staging environment, testing the templates created in the Dev environment (in BWise) and create monitoring steps to test the templates, Migrate the data to the production environment after rigorous testing in the staging environment.
• Customize the Confidential environment and develop it according to the business needs.
• Helped the Database team to create tables for Confidential data and provide backup and restoration.
• Create FC and FCPA templates for the business to sign off all the data that has been linked to fraud and corrupt information.
• Manage Confidential builder 4.1 used as client software for customizations in BWise (all environments)

HARDWARE AND SOFTWARE ENVIRONMENT:

Operating System: Windows, UNIX

Products/Tools: SAS 8.x, SAS 9.x, SAS/JMP Clinical, Confidential, BWise, HP QC/ALM

Languages: C, C++

RDBMS: SQL

Business Domains: Life Sciences, Healthcare & Manufacturing

PROFESSIONAL EXPERIENCE:

Confidential

Architect/SME

Responsibilities:

• Perform Customizations and development on Confidential as per the client requirements.
• Create Custom enumerations using Confidential builder and activate the metamodel.
• Create Financial Control Transaction review templates in Confidential and to link them to old templates, migrating the templates from Development environment to the UAT/Staging environment, Testing the templates created in the Development environment (in BWise) and create monitoring steps to test the templates, Migrate the data to the production environment after rigorous testing in the staging environment.
• Customize the Confidential environment and develop it according to the business needs.
• Helped the Database team to create tables for Confidential data and provide backup and restoration.
• Create FC and FCPA templates for the business to sign off all the data that has been linked to fraud and corrupt information.
• Manage Confidential builder 4.1 used as client software for customizations in BWise (all environments)

Software: BWise, HP QC/ALM

Confidential

Technology Lead & Trainer

Responsibilities:

• Worked on Confidential enhancements for Audit Management System and R&D.
• Created a new Centre of Excellence for Confidential to implement User Training environments for Confidential EQMS and presented the functionalities to 500+ users.
• Worked with Sparta System (Vendor) to Implement R&D CAPA module for Confidential for additional Organizations across Confidential .
• Worked on Risk Governance and Compliance modules in Business Wise infrastructure to implement the changes as per Confidential Requirements.
• Developed a separate WebAdmin portlet ( Confidential ) for Confidential to create Records, Audits and CRS for both internal and external auditing.
• Conducted Workshops on Audit Management System and R&D CAPA modules of Confidential across different organizations in Confidential globally. Provided Training to 500+ user base on the system and its functionalities.
• Trained R&D and Infrastructure teams including DBA’s and Admins on Confidential EQMS on the implementation and configurations. Created a Training environment for hands on practise with dummy systems
• Helped creating connections between SQL databases and Confidential application (AMS and R&D CAPA) during application enhancements with Sparta Systems.
• Helped in installing the complete framework including the application, Oracle 11g client, databases (Development, Test, Production and Training), and Reporting servers to make a connection with Confidential WebAdmin and reporting tools to generate reports.
• Worked on AMS module of Confidential on enhancements, which included adding organizations to the system, updating to the latest Confidential system (From 8.3 to 8.4.1 and then to 8.4.2).
• Worked on updating the dedicated AMS servers to windows server 2008 .The main work included the installation of AMS modules, migrating the installation files (dll’s), migrating reports, installation of Oracle components, Configuring Databases and filers to give access to files and folders on Confidential Servers.
• Created 800+ users in R&D CAPA organization lists from LDAP and provided BPO, Exception Manager, Power User and Viewer roles to the organizations.
• Worked on AMS (Audit Management System) server monitoring for Development, Test, Production and Sandbox environments for Disk occupancy and storage.
• Worked on data migration model from Dev to Test and to Production/Training environments using Confidential PR import utility tool and AMD migration Utility tools via AMS WebAdmin.
• Worked on generating reports on records from AMD WebAdmin utility (Crystal Reports) and helped to create snapshots of the data on the filers.
• Worked on records creations, editions and changing the status from pending locked to other status using flat files.
• Worked on Change, Problem and Incident Management for AMS and CAPA enhancements and to capture the changes in Confidential related SOP’s.
• Worked to create Confidential services on the server during the migration to one of the new locations and managed the servers including services like Confidential LDAP synchronizer, Confidential Co-coordinators and Confidential logs
• User account creations, setting up permissions, Migrating values from one environment to the other using migrating utility tool, Importing values to development, test, production and training environments using import utility tracker in Audit Management System
• Support Clinical Data Analysis for GBDS, CfOR and CDM Systems using SAS EG
• Scripts to start and stop SAS BI services, backing up WebDAV.
• Monitor environment for performance and proper operation.
• Support end users with access and connectivity issues
• Dataset analysis and testing using SAS 9.1.3 and SAS 9.2
• Supplemental works including Data Archiving, Data/System/Server decommission, Data Analysis.
• Created/Set up Decommission process to decommission multiple applications/systems/servers across different organizations in Confidential
• Step-by-Step process including all tires to decommission the application/system/server including data archival, storage and removing scripts.
• Worked as a lead to interact with different teams like Infrastructure, SAS, Storage, UNIX and Desktop support for decommissions process.

Software: Confidential AMS and R&D CAPA

Confidential

SME & Developer

Responsibilities:

• Project coordination.
• Complete administration of Virtual Desktop Infrastructure using XenDesktop tool and Active Directory including installation of applications.
• Changing the server settings, starting/stopping services, creating flat files to change the stages in an Audit Creation using Confidential 8.4.1.
• Worked on application group creation using Active Directory and managing different user groups using the same tool
• Worked on setting working directory is SAS GRID server for SAS Enterprise Guide 5.1 for running SAS Programs
• Integration of SAS Grid with other used tools/interfaces like RAVE, Oracle Clinical, and CDW.

Software: SAS 9.x, Unix, MS Virtualization

Confidential

Deployment Specialist and SME

Responsibilities:

• Project coordination
• Development and Enhancements to implement R&D CAPA module of Confidential .
• Architecting/Designing, Implementation, Quality, Benchmarking, Deployment and Production Support
• Administration including data migration.
• Monitoring and 500+ user role creation within different environments
• Providing user Training on the module functionalities across Confidential Globally
• Training R&D and Infrastructure Teams on the implementation and Configurations.

Software: Confidential 8.4.2

Confidential

Subject Matter Expert and Developer

Responsibilities:

• Project coordination with Vendor
• Client interfacing
• Responsible for designing the architecture, development, Quality, benchmarking, deployment and Production Support.
• Installing License managers and adding /maintaining licenses
• Connection to the desktop client using LSHOST values.

Software: Windows Server 2010, Cytel