Summary IT professional with 15 years of experience as a Systems Analyst, Systems Engineer, Writer, Administrator and SMEexperience providing infrastructure support and end user application support. I am skilled in supporting both Windows and in house systems. I bring an understanding of how technology changes and systems upgrades will impact business processes both in the day-to-day and in the long term. I am experienced in writing validation documentation to support both FDA and SOX regulations. This includes validation/compliance of network infrastructures and applications including disaster recovery and business continuity. I offer excellent leadership, communication and interpersonal skills as well as desire to continue to develop additional technical knowledge.

Experience

Wintel Administrator

Confidential

• Responsible for maintaining Windows environment 2000, 2003, 2008, 20012 Servers. Over 2600 servers maintained by group
• Responsible for the installation and configuration of both physical and virtual servers as needed
• Responsible for the updating and administration of the Active Directory domain
• Manage and support of client environment to provide centralized resource
• Developed and maintained installation and configuration documentation
• Troubleshooting and problem resolution of servers as needed including off hours and weekend.
• Provide all other server support as needed.

SharePoint Developer

Confidential

• Provide SharePoint development services for regulated and non-regulated SharePoint 2013 websites. Including, but not limited to upgrades to current design and new design features
• Provided IT end user support for all applications including regulated systems
• Provided IT support of all network systems including internal and hosted

Confidential

Application Administrator

• Provided end-user application support for the enterprise eDMSand auxiliary regulated systems.
• Represented IT on project teams for new module implementations or changes to the eDMS, ensuring application support model is in place prior to project completion.
• Represented IT on projects for the implementation of new regulated systems or changes. Provided IT support during project from initial architecture through to support. Provided all required documentation including but not limited to validation scripts, reports, SOPs and support documents.
• Developedand documented support plans for the eDMS and auxiliary applications as necessary . Interacted with IT Helpdesk support to coordinate support activities and application knowledge transfer.
• Authored user manuals and SOPs for the eDMS and associated administrative activities.
• Documented system-related activities for managing applications including support, maintenance and changes in a manner consistent with departmental SOPs.
• Interacted with the eDMS vendor and auxiliary system vendors as necessary , Alexion Pharmaceuticals IT staff and other departments as required to meet objectives.
• Provided application end-user training as needed.
• Assisted in development and execution of application test scripts to support validation activities and change control execution.
• Responded to Helpdesk calls and logs activities in a timely manner according to department standards.

Confidential

IT Consultant

• Provided IT end user support for all applications including regulated systems
• Provided IT support of all network systems including internal and hosted
• Worked on Disaster Recovery Plan including providing technical and compliance support.
• Provided Validation support for ongoing changes to the Company's Clinical Trials Management System
• Provided Training documentation and presentations for company systems as needed

Consulted

Confidential

• Performed re-validation of Regulatory Publishing system. Including review of and re-write of validation documentation including Validation plan, test scripts, and Validation report.
• Wrote and reviewed current SOPs in support of Publishing system
• Wrote SOP and Plan for Backup and Recovery of Information Systems

TConfidential

Senior Clinical Development Systems Analyst

• Responsible for implementation and administration of in-house and hosted computerized systems in support of the clinical development organization through the SDLC
• Determine and create user requirement specification and Functional specifications, URS, FS
• Responsible for Project Management of clinical development's computerized systems including installation, validation, administration and maintenance.
• Led 21 CFR Part 11 verification and validation projects for all regulated systems.
• Support of all GxP and SOX Compliance activities
• Conducted and participated in vendor audits to ensure 21 CFR Part 11 compliance and or SAS 70 compliance.
• Responsible for creating, reviewing and/or executing verification and validation documentation in accordance with 21 CFR Part 11 as appropriate to support clinical development's computerized systems or companywide systems used for regulated purposes
• Responsible for creation, review and storage of IT compliance documentation including but not limited to SOPs, Work Instructions, Validation Documentation such as URS, FS, VMP, Testing protocols IQ, OQ PQ UAT, plans and reports.
• Responsible for day to day administration / maintenance of clinical development's computerized systems.
• Responsible for assisting with general IT roles including system/network administration, Email administration, Backup administration, system/network security, etc.
• Successfully Completed a Qualification of the Trovis Network Infrastructure in support of GxP systems in 10 weeks. Qualification included protocol, test script and report creation along with script testing and creation/review of 17 SOPs in support of compliance requirements
• Successfully implemented Vendor hosted Safety Database system from Sentrx using Oracle Argus Safety
• Successfully Instituted a validated SAS client environment using a virtual machine set
• Successfully Instituted a validated environment for Regulatory group for use of Publishing tools

Confidential

Clinical Systems Analyst

• Provide technical support and services for the applications supported by Clinical Systems to all groups in Medical Research.
• Responsible for administration of SharePoint Portal Document site, Clinical Trials Management System for clinical group including design, maintenance and training
• Instituted an automated method of transferring documents directly into SharePoint site from CROs Vendors saving 250,000 per Phase 3 trial.
• Work closely with other departments in the acquisition and use of information systems technology and services used by all groups in Medical Research.
• Responsible for providing system management / administration for the Medical Research Repository and other applications as required.
• Responsible for identifying, evaluating, and taking part in the selection, and implementation of information technology products and services to support Medical Research
• Ensure Clinical Systems supported technologies are in compliance with all applicable regulations and policies both internal and external.
• Support and training of validated computerized systems as needed. Identifying and suggesting methods of resolution for risk management of the use of computerized systems especially in the areas of compliance or data integrity.
• Perform all SDLC activities as required for current and new systems

Confidential

Principal Systems Engineer

• System Mater Expert SME for the Global installation of QumasDocCompliance
• Qumas Certified Administrator. Certified to perform upgrades and patch installs.
• Consulting and Analysis: Meet regularly with IT colleagues and stakeholders to seek new opportunities to make their processes more efficient, effective, and/or secure. Make recommendations to utilize and implement improvements to IT systems to meet needs. Determine/gather requirements to present possible solutions or improvements.
• Client Support: Perform or advise IT colleagues on administrative and maintenance tasks for assigned applications/systems. Troubleshoot application and system problems that have been escalated, evaluate scope of impact, and develop remediation plan. Provide all required documentation based on validation and the SDLC.
• Project/Solution Activities: Support goals by participating on or leading project teams. Deliver on assigned tasks and action items. Follow SDLC of current and new systems
• Technical Focus: Serve as an expert on existing applications/systems and underlying architecture. Employ comprehensive knowledge to influence technology decisions. Identify IT or Pharma industry processes or technologies that could provide BI with a competitive advantage.
• Documentation: Determine documentation requirements and produce documentation as required in support of baseline and project activities including all required verification and validation documents. Create documents and perform testing as needed.
• Perform all other duties as assigned.

Confidential

Development Systems Analyst

• Successfully implemented a Validated Electronic Document Management System DocComplaince from Qumas compliant with regulation CFR 21 Part 11. Created and administered EDMS training for initial user base and subsequent users. Completed Implementation within five months positioning company to move into electronic submissions
• Founding member of Qumas Steering Committee and user community QuComm
• Responsible for providing analysis, oversight, installation and administration of in-house computerized systems for the Clinical Development, Regulatory and other dept.
• Responsible for administering / maintaining development's computerized systems Including but not limited to: Activating and deactivating authorized user accounts, performing content management including the establishment of directories, work flows and reports as needed by the user community, Conducting validation and computerized systems training as needed, Identifying and suggesting methods of resolution for risk management of the use of computerized systems especially in the areas of compliance or data integrity, Establishing and maintaining maintenance logs for minor and routine clinical development application activities, and Working through and with clinical development users' systems issues to resolution of the computer issue or to identify need to address additional training opportunities
• Responsible for creating, reviewing and/or executing verification and validation documentation as appropriate to support clinical development computerized systems or companywide systems used for regulated purpose
• Responsible for small and large validation projects such as change control projects for regulated systems and implementation of new systems.
• Responsible for creating and updating SOPs for IT Dept. and Development systems
• Responsible for maintaining IT Sox compliance and working with Accounting department to create process for financial reporting
• Required to Work with the user community to establish user requirements to solve efficiency and compliance needs
• Implemented a Qualified installation of WebSDM in support of the Clinical Dept. Worked with Clinical group to establish required parameters and processes for receiving clinical data for entry into the WebSDM system for analysis.

Windows Server System Administrator

Confidential

• Member of team that coordinates and executes technical support services for the company's information systems including support for personal computers, servers, e-mail, on-line and Internet resources, local and wide-area networks and standard office software.
• Responsible for purchases, installations, modifications, diagnostics and repairs of computer hardware and installations configurations and upgrades of client and server side software.
• Responsible for Administration of a Windows 2003 Active Directory Domain structure
• Responsible for Administration of Win NT 4.0, Win 2k and Win 2003 Servers including all maintenance and upgrades
• Responsible for the maintenance and upgrade of Windows Server systems including hardware and software and several department specific servers
• Responsible for all subsystems such as e-mail, servers, network support and Backup/Recovery.
• Personally responsible for the Backup/Recovery systems for entire company including disaster recovery of all critical systems through Veritas Enterprise Server
• Personally responsible for all Anti-Virus and Patch management company wide.
• Personally responsible for MS SharePoint Portal Server and Portal website including migration from SPS 2001 to SPS 2003,
• Responsible for Implementation and support of PostX Secure E-Mail Solution
• Assists in the maintenance and service of network back bone, not limited to but including upgrade of Cisco network switches and trouble shooting of systems.
• Responsible for research and implementation of system improvements and new technology for all departments company wide.
• Mentor to junior level technicians