University of California, Berkeley

San Francisco Paramedics Association

San Francisco, California, United States

- Organizes the launch of new trials by managing development and testing teams on execution, while also coordinating with the client to meet their needs.-Investigates issues in associated vendors that are integrated into the IXR system, e.g. EDC modules-Owns multiple Phase II/III clinical trials, maintenancing their transactional project activities throughout the duration of the project lifecycle e.g. project variable fees, inter-department workflow assignment, and issue escalation.-Proactively identifies and troubleshoots recurring trial-specific issues in system functionality, preparing prompt strategic intervention to increase trial efficiency and maintain data integrity. -Sets up master systems, additional study hardware, study site folders, and data folders for clinical trial execution.-Prepares functional study materials, including system requirements, data transfer documentation, etc. as warranted. -Produces data reports (e.g., weekly, interim, final, etc.) for submission to pharmaceutical clients.-Trains incoming teams of project specialists and managers on company function, core competencies, and the standard system development life cycle to establish familiarity with the company product. Contributes to initiatives that restructure training programs and documentation to accommodate evolving processes. -Designed Excel based data validated import sheets to assist in the exchange of study information.-Facilitated the close down and archival of system databases.

Signant Health

Project Manager

- Manage full product life-cycle of proprietary Randomization and Trial Supply Management software systems, which are developed to deliver inventory management and patient randomization strategies for pharmaceutical clinical drug trials.- Coordinate with software development, software testing, specification author, and statistical teams to define, build, test, and maintain systems from project award through close-down.- Main point of contact for pharmaceutical company clients, ensuring that systems are built according to the needs of the trial and remain flexible for any updates to system design.- Manage identification and resolution of clinical trial data inquiries, data transfers, and data changes for submission to pharmaceutical clients and supporting teams (clinical trial sites, Clinical Research Organizations, FDA and other regulatory bodies)

Associate Project Manager

Project Manager - Quality Assurance Feb 2014 - Oct 2017 - Develop and deliver timely and accurate testing of Fiserv clients, internal/external and provide expertise with Project Implementation across all Platform Databases and other system parameters - Provide support to clients to coordinate timely and accurate production environments- Assist clients with change management, including review of communications for technology announcements- Document functional and technical errors and participate in the correction and retesting of the items- Complete reviews of system and application requirements (functional specifications) for quality and completenessProject Manager - Implementations Mar 2009 - Feb 2014- Direct all project operations on 15 to 20 initiatives, including milestone activities such as Project Definition, Project Kickoff, Requirements and general status meetings with internal and client leadership - Identify client's existing applications and workflows to ensure all data is converted successfully- Analyze and determine Implementation requirements, manage and update the overall project schedule including scope control and timing of all phases of the work- Report to PMO Director and partner with business units on progress against project plans - Navigate teams/leaders effectively, work with internal departments including Sales, Design and Engineering, partner with vendors

Joshua Hughes Chen