Define the vision, roadmap, and prioritization of initiatives for the STEP MDM platform. Build, manage and mentor a team of PMs and POs to use data to drive ideation, scoping, and delivery of customer-facing solutions and underlying technology projects across multiple teams.

Define and prioritize initiatives for customer-facing solutions on the STEP MDM platform, manage internal and external stakeholder and customer feedback, and managing a team of PMs and PO’s.> Operationalized the rollout of the Pragmatic Marketing Framework to the organization, including developing templates, best practices, and training, and continues as the SME for Pragmatic within the organization.

Define problems, scope, and requirements for initiatives in the STEP PIM domain, as well as the platform.> Created and operationalized a data-driven, metrics-based process for prioritizing and delivering on customer product enhancement requests.> Tripled the number of requests solved per release and decreased average initial response time from over one year to under one week.

• Lead a geographically dispersed scrum team and ensure that the developed software product (STEP) meets business objectives, UX expectations, and provides value with each release• Build and maintain a prioritized product backlog that aligns with business strategy and objectives, and always contains a sufficient number of “ready for development” tasks• Engage with customers and colleagues to clarify business needs, validate solutions, and communicate resolutions, acting as a proxy between end users and the development team and serving as a stakeholder representing both internal and external interests• Prepare project justifications and solutions, including existing functionality documentation, mockups, use cases, user stories, etc and lead collaborative design workshops to facilitate technical solution decisions and estimates amongst a scrum team• Participate in and/or lead daily scrum, sprint reviews / demos, backlog grooming, sprint planning and retrospectives• Write user stories and acceptance criteria, ensuring that the delivered software product passes UAT and meets stakeholder expectations• Manage scope, expectations, and feature prioritization within projects to deliver MVP solutions when applicable• Ensure clear articulation of the functionality and messaging for delivered products, including creating concise internal and external documentation and materials• Take ownership of delivered solutions and software modules, including validating and prioritizing ongoing development and enhancement• Develop and implement best practice recommendations and functional procedures for the Technical Product Manager role and software project execution and delivery

• Design and implement a process for a mid-size technology company serving multiple enterprise customers to ensure that newly developed software (STEP) and functionality passes UAT and is clearly described for end users• Review product solution designs and user stories to suggest UX-based design improvements and highlight functional gaps• Coordinate with global stakeholders to capture demand for and drive acceptance of company-wide standards and processes, including development and implementation of a cross-functional change management strategy to ensure successful process adoption • Build, train, and manage a team of 10 Technical Writers and UAT Analysts• Develop robust technical product documentation and solution best practices for a variety of audiences and consumers• Develop and deliver training to internal employees and corporate partners on standards, processes, and end user software functionality

• Design and implement a QA process for standard and custom software (STEP) solutions, including methods for coordination with and utilization of an off-shore QA team.• Create templates and processes to drive effective requirements gathering, implementation, testing, and documentation of technical solutions• Establish quality objectives and standardization guidelines, and ensure that all delivered functionality and documentation meets the quality standards.• Manage a team of 5 on-site and 4 off-site QA Analysts/Test Engineers, including scheduling tasks and career development.• Advise customers on QA procedures and best practices.• Perform analysis of technical requirements and specifications; provide feedback and coaching to project teams to ensure that software documentation is clear, comprehensive, and testable.• Monitor and participate in communications between QA Leads and project teams to ensure that both internal and external project expectations are met.• Coordinate tasks and communication between on-shore and off-shore resources.• Develop and execute test strategies, test plans, and test cases.• Work with other departmental managers to develop and implement company best practices, methodologies, and training strategies.• Train new hires in multiple functional roles, including QA.

• Lead workshop and scoping sessions on site or via phone to gather business and software (STEP) requirements.• Quickly understand and analyze the business issues and data challenges of a customer’s organization and industry. Use this information to analyze customer needs, suggest methods of improvement, and write proposals and technical specifications for corresponding software functionality.• Develop accurate and complete testing plans for software customizations, including writing, reviewing, and implementing test cases.• Report, track, and resolve software issues and defects using helpdesk tracking system (Jira).• Provide training to clients on standard and customized software. Training may be in the form of written user guides, on-site workshops, or via WebEx.• Coordinate and lead software implementations and upgrades, taking into account the scheduling needs of the customer and the internal technical support team. Work with the customer to provide resolutions to issues encountered during the implementation and/or upgrade process.• Participate in the development and enhancement of the core software product by participating in solution design and scoping sessions, writing technical specifications, and leading the software testing team. • Assist Sales Representatives by providing industry knowledge and custom software demonstrations.• Configure standard software to meet specific client needs.• Inform Project Managers of status of tasks and develop alternate solutions when issue resolutions are in jeopardy.• Communicate clearly with internal and external clients from technical and non-technical backgrounds

• Carried out all data management activities including the creation of project documentation and data validation procedures to ensure that the quality of the data was such that internal standards and client expectations were satisfied.• Completed quality control and user acceptance testing on Oracle Clinical and InForm databases.• Reviewed and performed quality control on all study documentation, query generation and integration, discrepancy management, and case report form data.• Reconciled the clinical database against safety data, laboratory data or any other third party data. • Reviewed case report forms and electronic database set up for large and complex clinical studies.• Investigated and addressed client comments on all study documents and data.• Made decisions on a daily basis to ensure that studies remained on schedule and data quality remained high. Considered the impact of those decisions, weighed options accordingly and discussed with other team or department members as appropriate. Explained and negotiated with internal and external customers as required.• Served as the backup to the Data Manager.• Created interim data reports for dose escalation and safety assessments as needed.• Developed and maintained effective working relationships with internal and external clients.• Trained site users and less experienced staff on Oracle Clinical database operations and functions.• Maintained data in compliance with Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), and written protocols.• Led a team of 8 analysts to successfully prioritize projects and schedule assignments so that all QA work was completed accurately and on time.• Worked closely with staff to manage deadlines and promote on time delivery of quality data to clients.

• Monitored animal health and welfare in compliance with the Animal Health and Welfare Act and helped maintain facilities for AAALAC compliance.• Determined and documented clinical observations, including body weight, food consumption, environmental, and other pertinent data on the appropriate data collection system (or by hand when necessary). Ensured that all data were collected in compliance with appropriate Standard Operating Procedures (SOPs), Good Laboratory Practice Standards (GLPs), specific protocols, and regulatory agency guidelines. • Oversaw all data collection and procedures for studies, organized and reviewed collected data, responded to Quality Assurance audits, communicated effectively with internal and external clients, successfully scheduled multiple assignments, and ensured client and data confidentiality at all times.• Performed dosing and restraint procedures on laboratory animals, including mice, rats, rabbits, canines, and primates. Methods of dosing included intravenous, intramuscular, gavage, subcutaneous, and ocular.• Recognized deviations from expected results and potential problems and took appropriate action.• Prepared and reviewed staffing schedules and study calendars.• Recommended modifications in test methods or procedures and adapted existing techniques to new procedures and/or particular client needs.• Performed the specialized procedures of electrocardiogram collection, mammalian neurotoxicity screening, and tissue embedding.• Carried out commonly used clinical sampling techniques.• Trained and instructed less experienced staff.