TECHNICAL SKILLS

• Quality Assurance
• Project Management
• Systems Programming
• Strategic Planning
• AuditsOperations
• Regulatory/Compliance Issues
• Process Improvement
• Training - SEI CMM
• SDLC (Waterfall/Agile)
• SaaS - IaaS esting
• Validation

PROFESSIONAL EXPERIENCE

Confidential, Metuchen, NJ

Software Implementation Management

Responsibilities:

• Manage MaxisITs software Solution as a Service (SaaS) consultative approach in building/gathering customer requirements for teh scope of implementation; provide necessary documentation for teh solution Implementation; and, carry out successful implementation utilizing TEMPeffective project management techniques and quality compliance.
• Apply software development principals, concepts and techniques with a focus on business requirements analysis and application configuration to produce deliverables for client’s solution and implementations.
• Interface directly with technical peers at various customer sites during teh client implementation.
• Work closely with external customer project teams, internal implementation teams, core development, quality assurance, operations and customer care to provide Root Cause Analysis and fixes for defects found during all testing phases (e.g., UAT) and production deployment.
• Perform training and knowledge transfer to teh support organization for new client implementations.
• Responsible to test teh software with a focus to find bugs before teh customer sees them. It involves enhancing teh usability of teh software and reducing teh risk of 'defects' being found in teh software delivered.
• Build and manage TEMPeffective software implementation teams.
• Manage teh day to day operations of teh CTRenaissance working with teh Solutions Implementation Team, Delivery Management, R&D and Solutions Support department heads to ensure optimal operations and integrated efforts. Staff may include solution architects, implementation consultants, validation consultants, and solution training executives, and quality executives.
• Develop and implementdepartment SOPs, Computer Systems Validation Working Practice Guides to assure regulatory compliance and good clinical practices, which may include teh application call flow, user interface rules, and management of teh data and electronic records. Teh Validation Working Practice Guide may outline key components such as Validation protocol, summary, and basic script writing.
• Define and manage CTRenaissance Implementation standard package, which may include standard document templates, implementation guide, standard roles & responsibilities, quality compliance check-list etc. used to deliver MaxisITs SaaS.
• Work with software R&D and hosting vendors in discussing software issues or new customizations/enhancements /Integrations and carry out necessary upgrades in successive release plans. Create and track these issues using their internal ticket system.
• Identify, create, implement, and track implementation project key milestones through use of MS Project.
• Conduct daily/weekly meetings with internal implementation teams, R&D team, as well as teh customer stakeholders to review status, identify any obstacles, and provide status across departments and upper management. This also includes documenting all implementation progress, enhancement requests, configuration defects through use of teh defect/requirements tracking tool.
• Develop and provide monthly to executive management key operational metrics identifying performance load throughout teh year and historically. Metrics include average duration of standard implementations; data loads frequencies, implementation success rate, and key performance indicators. Quality performance metrics include number of configuration defects found during validation and production deviations found.
• Identify gaps and provide solutions in teh software development life cycle processes, User and Functional documentation, and software validation practices.
• Train new MaxisIT staff and assist with teh cross training of others outside teh MaxisIT department.
• Carry out and manage validation of all customer implementation based on 21 CFR Part 11 guidelines and TEMPeffective computer systems validation methodology
• Support business development in pre-sales engineering, proposal development, proposal defense, client presentations, and providing solution to client needs.

Confidential, Bridgewater, NJ

Systems Software Quality Assurance

Responsibilities:

• Responsible for teh implementation and delivery of ERTs SaaS ePRO IVR solution working with customers in identifying and building/gathering requirements for teh scope of their solutions implementation. Oversee teh development, testing, implementation; support and maintenance for each solution delivered.
• Manage teh day to day operations of teh ePRO system working with Project Management and Customer Care department heads to ensure optimal operations and integrated efforts. Staff includes 3 ePRO Technical Consultants responsible for teh IVR configuration and daily operational requests and 3 Validation Analysts responsible for teh validation of each IVR configuration.
• Developed and implemented ePRO department SOPs, ePRO Technical Consultant, and Validation Working Practice Guides to assure regulatory compliance and good clinical practices. Teh Working Practice Guides were written and implemented to be used as a reference when configuring and validating new IVR systems for current and future staff. Teh IVR Development Working Practice Guide outlines teh standard naming and programming conventions and general use of VOXEO's VoiceObjects software used in configuring teh IVR applications which includes teh application call flow, user interface rules, and management of teh audio and text files. Teh Validation Working Practice Guide outlines key components in teh Validation protocol, summary, and basic script writing.
• Defined IVR requirement documentation necessary for each IVR application delivered such as Release Notes, Recording list, User Interface rules, and Call script.
• Work with teh software and telephony software vendor VOXEO in discussing software issues with VoiceObjects configuration software, telephone number assignment, and any issue with their telephony software platform Prophecy. Create and track these issues using their internal ticket system.
• Identify, create, implement, and track IVR project key milestones through use of MS Project. Meet with teh staff weekly to review configuration status, identify any obstacles, and provide status across departments and upper management. This also includes documenting all configuration defects through use of teh defect tracking tool JIRA.
• Developed and provide monthly to senior management key operational metrics identifying performance load throughout teh year and historically. Metrics include average duration of calls, subject hang-ups, disconnects, and completed calls. Quality performance metrics include number of configuration defects found during validation and production deviations found.
• Work with telecommunication vendor VOXEO which hosts teh telephony software and provisions teh domestic and international phone numbers to meet ERT and client needs.
• Manage teh development and validation of teh Interactive Voice Recognition (IVR) implementation of all paper clinical assessments and client diaries awarded to ERT. This requires working with teh client and clinical psychologists in defining teh requirement.
• Member of a due diligence team in teh purchase of teh ePRO business knowledge and Interactive Voice Recognition (IVR) software from Health Technology Systems. Identified gaps in teh software development life cycle processes, User and Functional documentation, and software validation practices used by HTS.
• Developed User and Functional requirements for teh Visual Telephonic Audio Composer (vTAC) IVR legacy system used to develop and configure ePRO IVR clinical assessments and diaries. This included development and execution of a User Acceptance Test of teh vTAC software.
• Train new ePRO staff and assist with teh cross training of others outside teh ePRO department.
• Developed an internal employee satisfaction questionnaire with input from other Operations Directors and presented to Human Resources prior to building and implementing.
• Ensure highest standards of data integrity, utilizing data/process checks and QA; identifies and implements appropriate training program in conjunction with IT and Customer Care.

Technology: MS OFFICE, MS PROJECT, JAVA, .NET, VXML, XML, VOXEO VOICEOBJECTS, WEB DEVELOPMENT, VISIO, MS VISUAL SOURCE SAFE, ORACLE 10g, TOAD, BUGZILLA, HEWLETT PACKARD QUALITY CENTER, WINDOWS 7, JIRA

Confidential

Software Quality Assurance

Responsibilities:

• Work with Business Development, Research and Development, and Operations departments in identifying new functionality to address market and client needs. Define teh validation budget and resources needed to test teh business or functional requirement.
• Work with Operations department with teh implementation of new functionality such as providing teh ability to make and outbound reminder call to a subject prior to missing their call window, sending a missed call report after they missed their window, and generate an immediate alert based on a specific trigger during a call or after.
• Integrated ePRO with our EXPERT software utilizing teh reporting framework providing teh ability to automatically generate call findings and summary reports upon completion of a call or requested through an IVR menu option.
• Provide project management support for all Clinical Trial and Clinical Data Software Development Life Cycle projects. Develop and maintain project plans which document and track tasks from business requirement gathering through to implementation including project resources, time required, and costs across several departments. Escalate delays to Senior Management.
• Schedule and manage teh necessary Software Quality Assurance and User Acceptance resources for validation projects related to systems utilized by clinical operations staff or products developed for commercial use. Setup weekly status meetings to discuss testing progress and identify issues.
• Responsible for both Software Quality Assurance testing and User Acceptance testing. Work with teh Validation team and ensure teh Validation Plans are written, testing scenarios are identified (boundary, positive/negative, functional, and use case scenarios ) and documented, test scripts are detailed and accurate, execution of scripts have teh appropriate output, screen prints, reports, and have been reviewed. Validation Summary reports are written, accurate, and complete. Test binders are orderly, test scripts and output are documented accurately, and teh project is completed within teh deadlines defined.
• Staff responsibilities included: 10 direct reports, 6 Software Quality Assurance testers (up to 10 for EXPeRT v2 implementation, 3 for eDC application support), 4 Validation Analysts (up to 6 for EXPeRT v2 implementation); budgetary responsibilities include staff, contractors, and any technology required (such as Hewlett Packard’s QTP, Quality Center, LoadRunner, application and database servers).
• Perform annual reviews for all direct reports. Conduct regular meetings and provide required management support to assure project timelines are met with high quality deliverables.
• Identified teh Hewlett Packard automation tools used in building teh EXPERT v2 automated script test bed repository. Defined and documented standard naming conventions for automated scripts, test labs, test scenarios, and HTML testing result output. Used Quality Center to capture and trace all requirements from User Requirement to Use Case to Functional Specification to Test Script.
• Managed teh development of Hewlett Packard LoadRunner scripts which execute load and stress tests identifying potential bottlenecks with application or report logic implemented in teh EXPeRT v2 cardiac safety system.
• Create, build, and maintain baseline test databases for all software application validation efforts.
• Manage application defect tracking utilizing Bugzilla to document and track Cardiac Safety and eDC application software bugs from initial reporting and prioritization, working with teh Program Manager and delivery of teh resolution, retest and closure.
• Participate, as required, in client or regulatory audits. Work with internal or external auditors to rectify issues identified from audits

Technology: MS OFFICE, MS PROJECT, JAVA, .NET, VXML, XML, VOXEO VOICEOBJECTS, WEB DEVELOPMENT, VISIO, MS VISUAL SOURCE SAFE, ORACLE 10g, TOAD, BUGZILLA, HEWLETT PACKARD QUALITY CENTER, WINDOWS 7

Confidential, New York, NY

Director of Quality Assurance and Compliance

Responsibilities:

• Brought in initially to take charge of and ensure dat IT department was up-to-date, compliant, and TEMPeffective regarding all processes and systems. Company is a cancer research business heavily involved in physician services, health care insurance carriers, laboratory testing, and clinical trials. Company also owns Tamtron which develops supports and sells proprietary laboratory information system (LIS) PowerPath.
• Staff responsibilities included: 5 direct reports, 2 testers (up to 15 for PowerPath implementation), 1 tech writer, and 2 consultants; budgetary responsibilities included staff and any technology required (such as Mercury’s WinRunner); all in all supported 3 corporate sites, labs, and 3000 employees nationwide.
• Provided project management expertise with teh migration and implementation of a new LIS system. This included identifying and hiring internal candidates to customize and test teh new systems configuration, project milestones, and software rollout. All project costs, resources, time, and tasks were managed by a project plan.
• Provided critical project management experience managing a HIPAA gap analysis. Developed and maintained a project plan tracking project resources, time, and costs. Project completed 1 month ahead of schedule and under budget. All gaps were identified and managed.
• Facilitated meetings with teh business community to identify clear business requirements for new Billing application and system configuration for teh new LIS system.
• Successfully lead teh testing and implementation of a new billing application, various Web based applications including an Electronic Payment Remittance system, Previous Studies of historical data and automated teh processing of Cancer information Registry for an acquired company.
• Tasked to audit teh IT department; updated SOP’s to meet CAP, CLIA, FDA (me.e.CFR Part 11), HIPAA and other NY State and Federal regulations, and brought IT department within compliance of these standards and ensured adherence. Functioned as point person for all QA regulatory/compliance issues. Worked closely with Director of Regulatory Compliance for both internal and external audits.
• Inherited/completed project involving teh re-writing of billing interface to teh LIS system by developing and documenting a change control process; chaired board comprised of VP’s from several company areas. Determined requirements, test plans and configuration management for teh project.
• Built teh QA organization from ground up creating a master test bed documenting Impath’s clinical and billing suite of WinRunner automated scripts. Created standard test strategy, test condition, and test case templates for test team. Wrote and published a master test plan outlining responsibilities and test process from teh development to production implementation.
• Facilitated teh creation of a User Acceptance test environment, which eliminated their need to test in teh QA environments. This allowed teh users more time to run benchmarks volume and stress tests and kept teh integrity of teh QA

Confidential

Project Manager

Responsibilities:

• For Prudential Individual Insurance, implemented CMM Software QA Key Process area for 60 person project.
• Drafted and implemented teh projects Software Quality Assurance plan. Produced and executed all defined requirement checklists, SQA schedule, and baseline audits.
• Oversight for all level 2 KPA compliance; Requirements Management, Project Planning, Project Tracking and Oversight, Subcontract Management, Software Quality Assurance, and Software Configuration Management.
• Participated in corporate training for teh Capability Maturity Model (CMM).
• Responsible for all QA planning and coordination activities using MS Excel and MS Project for teh implementation of a new Term Insurance product and platform.
• Developed and tracked metrics for future estimates as well as monitoring teh status of teh current projects.
• Created standard test strategy, test condition, and test case templates for testers to use.
• Developed/maintained a traceability matrix to map each business and system requirement to test conditions and cases.
• For Prudential HealthCare, managed several large Y2K projects. Also managed remediation of SAS, COBOL, CLIPPER, Visual Basic, and Visual C++ code and system testing.
• Maintained a budget managing actual hours, costs, and tasks against planned hours, costs, and tasks escalating any issues to teh appropriate management which would impact teh budget and project plan.
• Staffed and managed multiple programming and testing teams of up to 35 direct or indirect reports.
• Ensured adherence to corporate QA standards for teh project deliverables as well as client/audit requirements.