Own, manage, and support Lab Systems Portfolio including:Overall product and product features from concept to end of lifeManagement of the product team to ensure that business, quality, and functional goals are met with each product releaseDevelop and prioritize features and stories ensure work focuses on those with maximum value that are aligned with product strategyPlan releases and upgradesInspire and motivate the product team to deliver innovative and exciting solutions with an appropriate sense of urgencyDevelop lab systems roadmap for Amgen Operations; accounting for current and future business needs and make technology decisions. Collaborate with IS Architects, Infrastructure Leads and Business Analysts to develop roadmaps supporting organizational priorities and platform improvementsWork with multi-functional representatives across Process Development and sites to align business processes with Holistic Lab, PLM and Big Data technology capabilitiesLead vendors and contractors providing guidance as necessary to ensure the delivery of workLead key strategic supplier relationships from both product and services side, as required.Ensure compliance with Amgen and industry practices policies, procedures, legal requirements and goals of project sponsors

Responsible for all aspects of organizational Laboratory Information Systems (e.g. Product Management, LIS Support, Vendor Management, Systems Integration, Instrument Interfacing, Systems Configuration and Maintenance, etc.). Responsible for managing LIS/LIMS upgrades, software release review and testing. Manages a global team of Software Engineers and Sr. LIS Analysts and other IT Support Staff.Defines and owns the technology delivery process, as well communication of metrics, delivery dates, needs and budget requirements to senior management.Additional responsibilities include managing and providing a vision for all aspects of the Company’s Laboratory Information Systems (LIS) / Laboratory Information Management System (LIMS).Duties and Responsibilities•Work with business leadership to ensure alignment of IT project roadmap to overall business objectives•Plan and manage LIS vendor led software development activities •Responsible for ensuring software delivery adheres to best practices for enterprise level design, documentation coding and testing standards•Responsible for ensuring software delivery process adheres to regulated SDLC for GCP applications.•Ensure all IT related requests are implemented in accordance with approved SOPs and/or regulatory guidelines.•Provide end-user IT/technology support.•Support laboratory applications and technologies purchased from third-party vendors, as needed.•Ensure client data is processed and delivered in a timely and secure manner.•Manage the IT- LIS staff effectively, providing employees with direction, guidance and feedback to ensure IT projects and activities are completed in a timely manner.•Prepare and manage the annual LIS project related budgets.•Provide LIS direction and implementation for new and existing initiatives and services•Drive innovation that will lead to operational efficiencies and/or improved reporting and data availability.

Assist in the implementation of STARLiMS v10 Laboratory Information Management System, concentrating on instrument interface configuration, set-up, testing, and troubleshooting for all LAB locations. Identify and analyze business problems and defines the scope of activities required to address the issues, including requirement definition, process review, impact assessment and operational streamlining where appropriate.Responsible for all aspects of projects, including documentation of project needs, analysis/research of needs and possible solutions, identifying technology and business solutions, gathering, documenting and updating business requirements; reviewing workflow process mapping; developing business testing strategies and working with project members to execute the test plan, recommending preferred solutions, and implementing recommendations.Manages project documentation (implementation plan, issues log, process maps, etc.) and documents process flows and gaps. Assess, research, analyze and document sponsor/stakeholder needsDevelop and maintain strong relationship with business partners and internal/external team members. Identify issues and escalates/manages resolution as required Coordinates and provides support to the business with the process implementation

As a contracted GE Ultra Lab Specialist with this client, I worked remotely during "off--hours" and assisted with project-based work, primarily involving instrument interfaces. I worked with on-site staff to update Ultra master tables, update Microbiology tables (i.e. Antibiotics, Organisms, Antibiotic Cascade, Interpretations, etc.), update instrument tables and perform systems' testing and validation.

Served as the Senior Business Systems Analyst for the STARLiMS V10 implementation at the Centers for Disease Control and Prevention (CDC), Gathered user requirements and workflows for implementation of Laboratory Information Management Systems. Communicate requirements to STARLiMS developer and perform system validation on any application / code changes.Develop Use Cases for technologies surrounding the management of data across various applications/systems/departments.Develop process workflows documents, perform gap analysis and assess best methods for implementing LIMS and additional technologies.Assist with the interfacing of instruments with the LIMS and the integration of external systems utilizing HL7 messaging standards.Validate systems, manage changes and document requirements and various testing scenarios.Provide product demonstrations and training sessions to key product stakeholders, implementation team members and users in the laboratory.

Led project to integrate EMRs with LIS. Maintained all HL7 specifications related to various EMRs integrated with LIS. Provided EMR-LIS training and testing on-site at Doctor's clinics/offices.Served as LIS Team Lead for our internal GE Centricity EMR / LIS team interfacing projects.Responsible for the implementation of new applications, upgrades, and modifications to existing systems.Analyzed business/clinical needs and requirements. Evaluated the operational workflow that is applied to the system. Created system specifications from user requirements.Create test plans for software upgrades/releases and system modifications.Responsible for various aspects of SCC's SoftLab system build and implementation (e.g. instrument interfacing, Gene module, table build, lab workflow analysis)

Managed and coordinated the qualification and deployment of laboratory systems globally at Quintiles Laboratories.Interfaced instruments globally and maintained testing, troubleshooting and QC of various interfaces.Managed, mentored and trained regional LIS Analysts serving in global Quintiles Laboratories (i.e. Atlanta, GA, Singapore, Scotland, China, Japan, India, Brazil and Argentina).Managed vendor relationships, contracts and invoicing with GE (LIS) and Data Innovations (Middleware).Served as LIS Lead on laboratory global harmonization projects.Collaborated with business leaders, end users, other IT departments, and software vendors to develop and provide appropriate support strategies for regional and global business applications.Participate in quality improvement initiatives and ensured compliance to all regulatory agency requirements.Acts as a subject matter expert on LIS strategies, procedures, policies, and methodologies.

Served as LIS Lead in designing, configuring and implementing laboratory systems for Community Health System Hospitals.Consulted with and assisted users in making the most effective use of applications through training, testing, and system analysis.Assisted clients through the go-live phase of new laboratory information system implementation/deployment.Responsible for providing workflow analysis, gap analysis and creating project timelines for LIS implementations.

Maintain GE Ultra Laboratory Information System databases and associated master files to ensure the integrity of system data/processes and that the expected results are achieved.Executed lab test builds by defining, developing, analyzing, testing, modifying and troubleshooting applications to maintain system integrity and maximize available functionality.Worked closely with lab management/staff to effectively modify the assigned databases to meet current and future lab requirements, and developed and supported significant medical device interfaces.Worked closely with lab staff and vendors in the support of medical device interfaces.

Provided full implementation of Orchard Software’s Laboratory Information System software applications, including the installation of hardware, software, and network components.Communicated with executive management and laboratory administration as to the status of LIS implementation.Provided telephone technical support for Orchard’s client base when not conducting installation projects.Conducted on-site client training for system administrators and end-users.Assisted clients through the go-live phase of their new laboratory information system.

Responsible for mentoring and training Associate Project Set-Up Managers and Project Set-Up Specialists in designing global laboratory services for clinical trials.Designed assigned protocols and major amendments, which require working knowledge of database and programming specifications, global logistics, data management and laboratory testing.Directed the activities of the Sponsor/CRO, Project Manager, Associate Project Set-Up Managers and Project Set Up Specialists in designing and organizing the components of clinical trials.Participated in technical reviews of new studies with the Laboratory Global Medical Director to determine if Quintiles is capable of handling the specified laboratory requirements.Coordinated the activities of all central laboratory departments to make sure studies are launched within a specified time frame.