Donna Moy Email and Phone Number

As a Product Owner, regularly meet with Business Sponsors, to develop and deliver tools providing a single-source of trusted data for leadership and operational teams to access real-time views of portfolio and projects' progress. Present and demonstrate products at poster sessions. As a Product Designer/Business Analyst, liaise with the BSO & Engineers to gather and create URSs and clarify requirements via process flow charts and decision trees. Regularly communicate with Tech Security & Risk to review & approve project documentation including: Quality Plans, Test Plans, System Access Plans and Test Summary Reports. Conduct System Usability Scale (SUS) surveys and share results with the Business Sponsors and User Community. -IDBS E-Workbook Platform - Efficiently captured experiment data in a structured manner that improved accessibility to data for analysis and re-use. Took the initiative to learn IDBS' security model to customize security structures to meet customer needs. Trained an off-shore team to support the security models.-Parntered with the Small Projects team to develop and deliver small-sized non-validated products and services that consistently met User's needs and requirements.

Key member of the R&D IT business partnering team with a focus on Global Medical Affairs and Pharmacovigilance. Engage customers, elicit and accurately document requirements. Establish strong working relationships with vendors and business technology resources resulting in solid application development, deployment and support.-Assess user needs, assumptions, dependencies and risks for potential solutions to technical and business issues for both new and legacy systems. -Conduct data verification testing on both validated and non-validated systems prior to integration, production release or decommissioning, which includes authoring Validation Plans, Scripts and Validation Summary Reports.-Data Management Lead - Facilitate and coordinate the acquisition of data and the verification by global markets as well as the uploading of verified data to Veeva CRM. -Worked closely with MSLs to identify and prioritize CRM requiremetns to capture interactions with HCPs. -Partnered with Veeva Configuration Specialist and Accenture to determine scope, feasibility of changes and timelines. -Designed a CRM tool User Guide which was distributed to the MSLs on a global basis. -Provide Tier 2 support for Veeva CRM. Conducting training sessions to transfer product knowledge to the off-shore support team.

Facilitate the development of McKesson's software solutions for payors and providers. -Interview clients, document business requirements, analyze and interpret collected information, manage on- and off-shore development and testing efforts and demonstrate final products software to the project team leads. -Primary liaison between the project team leads and developers, writing clear, concise user stories, requirements and acceptance criteria. Reinforce the requirements with developing screen mock-ups and workflow diagrams.

Managed the development and the implementation of enterprise level clinical trial systems and/or regulatory systems for pharmaceutical Sponsors and CROs.-Fostered client relationships, positively contributing to the growth ePS' business and reputation by listening to clients, understanding their needs, establishing deliverables and timelines and communicating project statuses on a regular basis with clients. -Liaised between the client user groups and ePS' technical and testing teams to ensure what is being developed for the client is built to the client's specifications and functions per requirements. -Followed the SDLC processes to develop and deliver client applications. Authored Use Cases, URS, FRS, DS and Traceability Matrices and conducted validation testing, including script writing and execution, and test summary documentation.-Consistently provided client deliverables on-schedule, meeting client needs and/or exceeding expectations through careful planning of activities surrounding the project.

Provide technical support for clinical applications used by global clinical study teams. -Delivered specialized training to study teams, investigators and site staff on the PfizerTrials Portal which enabled teams to maximize the portal's potential for their study and resulted in improved communications with the investigator sites. -Conducted vendor training and oversight which improved the vendor's issue resolution rate and improved client satisfaction. -Designed and developed BRIO and Business Objects reports for the Development Operations organization which enabled teams to identify areas that were performing well and areas that required more attention. -Executed validation testing to migrate the clinical data from Wyeth into Pfizer databases and successfully decommissioned and archived legacy Wyeth applications which reduced maintenance and redundancy.-Communicated the decommissioning activities and timelines and explained how the decommissioning efforts would affect the study teams. This better prepared the teams and their study sites for the changes. -Reviewed and tracked missing documentation for an internal audit conducted on the reporting system. Created and implemented a consistent naming convention for electronic files which shortened the audit time and smoothed the overall audit process.

Represented the Global Clinical Development and Support (GCDS) department as the application/system owner of multiple clinical applications used by study teams worldwide. -As the eClinical portal system owner and SME, responsible for all initiatives that affected the eClinical portal or were impacted by the eClinical portal. Communicated the anticipated downstream effects to appropriate groups. Composed training material for portlets within the eClinical portal which was used to create automated, web-based, self-paced training modules. Reviewed online modules for accuracy and provided feedback prior to production deployment. -Provided global support to Clinical Site Monitors in the field and confirmed the study was set-up in in the portal, ready to receive data from sites and ensured Site personnel were assigned and completed all necessary training prior to study start. -Wrote Use Cases, URS and FRS documents for the eClinical portal and portlets. Coordinated validation efforts by authoring validation plans and protocols and executed validation scripts as necessary. Documented test results and finalized validation summary reports. -Supervised a team of technical and data savvy report builders located both on and off-shore to work with global end-users in creating or modifying standard and/or ad hoc reports that met the needs of the business. -Conducted vendor analysis, selection and training. Managed and provided oversight for an off-shore vendor who provided 24-hour access and technical support for the eClinical portal and RAVE.-Partnered with production support to resolve Sev-1, -2, and -3 issues that affected the eClinical portal or any of its applications. Consistently met all SLAs.-Successfully prepared the GCDS department for two separate internal audits on the eClinical Admin portlet and MERLIN with no major findings on either. Responded to all FDA, PMDA and Internal audits within specified deadlines.

Worked with regional teams to analyze and enhance the current claims adjudication process. Conducted UAT testing on custom software built to auto-adjudicate claims which improved the consistency within claims processing and processing time. -Through insight and understanding the needs of the business, developed effective working relationships with team members, peers, Directors and VPs across organization lines. -Collaborated with Operations Management and Policy & Procedures teams across six regions nationwide, which resulted in successfully transitioning 18 projects from UAT testing to Production.

Represented Comcast Cellular's customer relations departments when working with cross-functional teams during the development and launch of new products, features and services. -Improved internal and external customer satisfaction (C-Sat) results measured by J.D. Power and Associates, by supervising the First Call Resolution team in creating and testing alternative solutions to overcome barriers that prevented quality customer service from being provided. -Partnered with the training department to ensure all training requirements and deadlines were met. -Provided technical support during the launch of all assigned projects and created knowledge base articles (KBAs) used by the training, customer service, major accounts and sales departments. -Successfully lead the entire customer relations department through a strategic plan to consolidate Cellular One's policies, procedures and offices into one centralized location.

-Planned, organized and conducted customer service classroom training for new-hires. Managed the six-week, on-the-job training and ensured all trainees were able to perform the required job at the end of training sessions. -Addressed personnel issues with trainees in accordance with company policy. -Wrote, coordinated and produced brochures, training materials and audio-visual training tools used for reference by various departments including customer service, major accounts, sales, marketing, distribution, credit and accounting.