Cecille Matsuo Email and Phone Number

Provide subject matter expertise in utilization of clinical business systems that support clinical development operations, focused on Global Data Management and regulatory compliance.Responsible for providing, in conjunction with functional subject matter experts, expertise in clinical development operations requirements, understanding of assigned clinical business systems, aligning with process owners, and embedded within the respective GDO functions. Represent the end-user needs of the global development operations organization to the R&D IT organization.

Lead the development and implementation of a comprehensive quality assurance program focused on minimizing, preventing, detecting, and correcting issues affecting ALCOA principles of GxP data generated by FibroGen or its contractors. Ensure regulatory compliance, resolving quality issues at the study level, managing CAPAs for Clinical Data Management, Clinical Data systems, and analytics, and improving processes. Oversee risk assessments, KQIs and KPIs, CAPA trends, and functional inspections, as well as conduct internal and external audits of processes and vendors. Duties extend to overseeing quality deliverables across clinical data management and analytics, providing guidance to staff on quality and process concerns with emphases on data integrity and data standards, and serving as a primary liaison between Clinical Data Management, Biostatistics, and Clinical Quality Assurance.

Accountable for successful electronic COA (eCOA) in individual clinical research studies from study design to close out in collaboration with the study team. Lead eCOA project timelines, translation, eCOA study specifications, completing UAT, and ensuring collection of eCOA is in accordance with Allergan/Abbvie Standard Operating Procedures (SOPs) and ICH/GCP. Provide direct leadership and oversight of eCOA for sourced studies and studies out-sourced to Clinical Research Organizations (CROs). Responsible for creating and enforcing eCOA systems standards, handling vendor performance, and supporting training & education of partners. Actively contribute in functional process improvement initiatives in global development.

● Manage external vendors to implement study specific IVRS (IRT) and ePRO systems● Support execution of contracts and budget forecasting● Ensure vendors provide service and support as outlined in contract terms and based on agreed upon performance goals● Manage communication and expectations between the study team and vendors● Propose solutions and efficiencies to resolve issues with minimal impact to the sites/study teams● Liase with global and inter-departmental functional groups● Produce and deliver risk assessment for changes requested to the system post-production release● Provide consultation and best practice guidance to the stakeholders (operations team and to the vendor)

Direct internal and/or outsourced activities for implementation, maintenance and support of systems provided by third party vendors (e.g. Interactive Response Technology (IRT), electronic Clinical Outcomes Assessments(eCOA) tools) in support of multiple clinical research projects. Responsibilities include:● Being the Allergan CDMP point of contact to one or more global third party vendors● In collaboration with the global third party vendor(s), assist in ensuring overall quality systems and regulatory compliance● Ensuring effective delivery of third party vendor services - using metrics to ensure timely contribution of third party vendors interacting with various clinical study teams● Maintaining an understanding of new technologies and best practice to support improvement in CDMP services from vendors● Managing required services within defined budgets● Assist with Inspection Readiness activities, including preparation for sponsor audits and regulatory inspections● Ensure escalation and resolution of study data issues and systems performances● Maintain and demonstrate a thorough knowledge of the assigned therapeutic area(s)

Collaborates with a cross functional team of stakeholders (including Clinical Teams, Biostatisticians and study team representatives) and vendors (IxRS and ePRO provider representatives) to facilitate and support the design, implementation and maintenance of outsourced electronic solutions for a clinical trial. Provide technical oversight to ensure that the study specific electronic solution adheres to the study protocol, industry regulations, best practices as well as company policies, procedures and guidelines. Key responsibilities include: ● System lead on assigned IxR and ePRO projects, serving as the subject matter expert and insuring on-time delivery of the project into production. ● Manage and oversee study level system requirements meetings with Sponsor and IxRS/ePRO providers ● Validate the accuracy of the IxR and ePRO design entering production and expectations from IxRS/ePRO is delivered ● Work with with the 3rd Party vendor to deliver IxR and ePRO design that meets business expectations● Manage project related costs, contracts, timelines and associated activities ● Identify opportunities for system improvements and enhancements. Assume primary responsibility for validating UAT test plan documentation and leading UAT execution ● Serve as the business interface and primary point of contact for all IVR and ePRO related projects, recognizing and tracking study-related technical issues to resolution ● Contribute in design solution meetings, and provide a supportive framework for continuous process and quality improvements ● Assess impacts of potential design and system constraints on requirements and obtain approval from impacted business owners when necessary ● Post implementation monitoring of systems and oversight of change controls from design to production.

Served as project manager for IVRS & ePRO activities, overseeing the execution of the IVRS & ePRO strategy for multiple studies. Responsible for ensuring e2e support is provided to clinical study teams. Ensured all aspects of the IVRS & ePRO project plan (from protocol development through system closeout) are executed on time and with high standard quality. Ensured adherence to, Allergan clinical and regulatory data management standards. ● Ensured vendors are planning and managing timelines and employing risk management techniques across all projects in order to provide service and support as outlined in contract terms and based on agreed performance goals● Monitored execution of IVRS & ePRO development process from Kickoff to system go live, ongoing system change control, system closeout and database lock activities. Coordinate standards and oversight of consistency across Allergan therapeutic areas● Identified areas for process improvement and lead improvement activities. Applies IVRS & ePRO expertise to day-to-day activities when issues are escalated● Interacted with both technical and clinical staff to ensure their needs are met. Accountable for making decisions regarding IVRS & ePRO process, issue resolution, and deviations from standards. Provide consultation on PRO modality, benefits, risks, costs, and process● Served as an IVRS & ePRO Subject Matter Expert to internal & external stakeholders to provide support for the development & maintenance of relevant documentation, including applicable SOPs, and guidance documentation● Defined and implemented process with vendor representatives, monitoring and analyzing vendor and Allergan performance metrics, performing root cause analysis and identifying corrective actions, and serving as point of escalation for vendor issues●Provided risk assessment for changes requested to the system post-production release and consultation for best practice guidance to the stakeholders (operations team and to the vendor)

Perform complex validation and verification of all software in an Agile Scum environment. Consistently contribute to the improvement of the QA process by thorough understanding of DataLabs and DataLabs Designer software and its developments to ensure delivery of the functionality according to the business requirements, including streamlining processes to produce and maintain appropriate and comprehensive quality process specifications and documentation as required during the development and implementation of the EDC and Study Designer products.● Work interactively with Business Analysts, Development, and Project Management teams to effectively translate EDC and Study Designer software requirements, present valid test ideas and formulate detailed test scenarios for execution● Compile, execute, and document validation protocols for product processes and software, ensuring correct implementation as per standard validation procedures and Re-validation as required due to engineering changes, deviation analysis or upgrade in systems and material.● Create test scripts and formal validation documentation for DataLabs EDC and DataLabs Study Designer software, including RTSM integration, Reporting, and Exports in compliance with Good Clinical Practice Regulations (GCP).

● Became test and validation Subject Matter Expert, being a single point of contact for team members and associated departments for information about an enterprise level virtual communications tracking system● Responsible for business and functional requirements for large scale system development requirements, including interaction with internal business and operational clients, and internal IT groups● Developed test scenarios and conducted testing efforts including the recording of testing issues● Created training documents and delivered end user and new hire training sessions● Provided post -production support for system issues, including research and follow-up● Participated in meetings with stakeholders and development to discuss business needs and manage stakeholder expectations as projects progress

● Responsible for supporting end-to-end and other testing efforts by the testing, maintaining, and analyzing of a central repository application based on functional business requirements ● Tested functionality of multiple products against the system and assured the application met documented standards, had ability to withstand installations, upgrades, and followed to end of release cycle● Technical subject matter expert in web-based application to track real time status of multiple provisioning systems● Liaison for issue resolution between developers and end users across multiple applications and jurisdictions● Responsible for project planning on both short and long term basis, including requirements, scheduling, and execution of test scripts● Assisted production support in providing system load, acceptance, and certification for all major and minor system installations ● Provided updates and distributions to management and regarding issues and progress