Clinical area solution BP. Include Planisware, Veeva RIM, Veeva CTMS and Veeva eTMF solution implementation.Regulatory Business PartnerPlay business partner role for regulatory affairs function. Knowledgeable in regulatory stand- ards and guidelines governing clinical development, ensuring adherence to regulatory re- quirements throughout project lifecycles.Support Regulatory team routine work and address process pain point.Consultant on solution for business process… Show more Clinical area solution BP. Include Planisware, Veeva RIM, Veeva CTMS and Veeva eTMF solution implementation.Regulatory Business PartnerPlay business partner role for regulatory affairs function. Knowledgeable in regulatory stand- ards and guidelines governing clinical development, ensuring adherence to regulatory re- quirements throughout project lifecycles.Support Regulatory team routine work and address process pain point.Consultant on solution for business process enhancement, lead and coordinate for solution implementation.Clinical Development BA and PMPlay as an IT PM and BA role for solution implementation through clinical development func-tions. Veeva RIMGuidance to business of submission process control solution decision making. Utilized Veeva RIM to efficiently manage regulatory submission process. Throughout the implementation process, follow company’s GxP validation process. Collaboration between business SME and solution vendor, crucial to ensure the successful deployment and adoption of RIMContinues improvement and optimization efforts are undertaken to enhance the efficiency and effectiveness of regulatory process support by Veeva RIM. Gathering feedback from us- ers, analyzing system usage and work with Veeva managed service team for change request as need.Complete migration of historical data and archived submission package into Veeva RIM.PlaniswareUtilized portfolio management tool Planisware to efficiently manage clinical development pro- jects, ensuring adherence to timelines and budget constraints.Collaborated closely with cross-functional teams to identify process inefficiencies and imple- ment solutions for improved operational efficiency.- Provided strategic guidance to stakeholders on leveraging technology platforms for enhanced project management and resource allocation. Keep the clinical master data flow among the different systems. From top to downstream and make the data consistent. Show less

Responsible for timeliness and quality of internal and external business support and maintenance mechanisms of the electronic document management system (eDMS) and related compliance and efficiency of document management processes.Work Outline• Act as eDMS SME for process and related technical specification for a defined area of expertise or geographical region:- Requirements gathering and translation to functional specifications in close collaboration with eDMS/Business SME’s, IT… Show more Responsible for timeliness and quality of internal and external business support and maintenance mechanisms of the electronic document management system (eDMS) and related compliance and efficiency of document management processes.Work Outline• Act as eDMS SME for process and related technical specification for a defined area of expertise or geographical region:- Requirements gathering and translation to functional specifications in close collaboration with eDMS/Business SME’s, IT and software vendor to ensure efficient and compliant eDM pro- cesses- Promote best documentation practice to various line functions to ensure compliance with GCP guidelines and respective SOPs- Design, optimization, maintenance, implementation/rollout of training mechanisms in close collaboration with other Clinical Document Governance and Management (CDG&M) func- tions- Lead and drive improvements and innovation on business and technical aspects, (feasibility assessments and implementation activities)- Participate in global cross-functional business process performance or clinical development improvement initiatives.- Play Business lead of IT project with activities including test case creation, informal/formal testing, SOP revisions, migration preparation, business support concept design, establish training material concept & content, plan/conduct trainings & rollout activities as well as to manage Extended Business Team and other local stakeholders- Coordinate system maintenance activities and system upgrades in close collaboration with IT, Superusers and Key Business Functions under guidance of eDMS CoE Lead.• Maintain oversight of service quality of the Document Management system:- Contribute to the oversight of operational activities for efficiently maintaining the electronic clin-ical document management system.- Monitor Business Administration performance and its impact on the business organization.- Engage functional or regional Show less

Business Analyst & Project ManagerBusiness Analyst• Communicate with different business stakeholder to do requirements gathering and evaluation,proposal the good solution for implementation the requirements.• Coordinate with IT solution team or vendor to implement the requirements based on the agree-ment.• Working on the URS, FS and other related documents.• Arrange the training and further collaboration with the business stakeholders, key users, andend users… Show more Business Analyst & Project ManagerBusiness Analyst• Communicate with different business stakeholder to do requirements gathering and evaluation,proposal the good solution for implementation the requirements.• Coordinate with IT solution team or vendor to implement the requirements based on the agree-ment.• Working on the URS, FS and other related documents.• Arrange the training and further collaboration with the business stakeholders, key users, andend users based on the communication plan.• Support the business users during the operation and maintenance phase.• Support sponsor or key stakeholder to analyst and evaluate for the vendor solutions based onthe BA perspective and IT perspective, which support them to pick up the vendor.• System I involved as a business analyst: ARISc solution replacement, TIMS (An in house buildCRA resource utilization and assignment system), PDMS (An in house build study cost track- ing, resource forecast and finance report generated system).PM• Lead the project, define WBS, arrange resource and control project schedule.• Get involve into Business case discussion and support to delivery the Project Charter, arrangethe kick off meeting with all the related resource, stakeholders and sponsor.• Coordinate the resource (both internal and external) and keep the status on time and updatedto all the stakeholders. Evaluation the risks and control the risk.• System I lead: Clinical data backup system. (A vendor provided software), PV system replace-ment (An ARISg provided PV system), eCTD (An initial business case gathering and SOW generated support.) Show less

I work and play different roles in a global search team of an innovation solution called Search Across Systems. It is a cross clinical trial solution that brings all the clinical trial data and related documents in one platform, provides full content search (includes clinical data and clinical documents), customized filters, data exported and document preview features to the end users.As a BA, I coordinate with business process owner, key stakeholders of each partner systems (eTMF, CTMS… Show more I work and play different roles in a global search team of an innovation solution called Search Across Systems. It is a cross clinical trial solution that brings all the clinical trial data and related documents in one platform, provides full content search (includes clinical data and clinical documents), customized filters, data exported and document preview features to the end users.As a BA, I coordinate with business process owner, key stakeholders of each partner systems (eTMF, CTMS, IDM , ARISg, GPRS ) and key users for requirements gathering, elicitation, collaboration and solution evaluation.Work with technical team to support implementation and deliver the URS, FS and conduct the UATCollect and analysis the user feedback, support the implement of users’ change requirements and keep system enhancements continuously to meet business’s demands. Support the user adoption: prepare communication materials. (Like the announcement letter, poster or etc.); Travel to different countries (US, Canada and Switzerland) for system promotion and training; Interview the end users for collections their experience and use caseAs a DSM, I work with business process owner and technical team for system operation support and M&E release. Collaborate with DSM in partner system impacts evaluation. Facilitate the CCB meeting to prioritize the new demands. Improve the system incident management and change management process. Design the usage reports by using Tableau. Responsible for the related document and keep them update to date: include SRA, DCR, SLA and etc.As a validator, I follow PMM (Project Management Methodology) and CSV, work with IT quality and security, business quality to monitor and validate the system during system lifecycle include Initial, Planning, Build and Testing, Release, Operation and Close. Design test plan, test scripts and execute the testing for system. Show less

Work as a senior tester in Accenture. The project belongs to CGS and the team is called NP.Which is the client app for sales to do activities of selling their products.Our business users are: Ferrero Russian and Danone China.My responsibility is on validation before the project go-live.Design the test plan and test script by functional design. Attend two CGS project during almost one year working in CDC. 1. Dumex China. (CR) write the test script by change requirement and… Show more Work as a senior tester in Accenture. The project belongs to CGS and the team is called NP.Which is the client app for sales to do activities of selling their products.Our business users are: Ferrero Russian and Danone China.My responsibility is on validation before the project go-live.Design the test plan and test script by functional design. Attend two CGS project during almost one year working in CDC. 1. Dumex China. (CR) write the test script by change requirement and participate the unit test, sit and UAT. Communicate with Dumex client and get the feedback from them. 2. Ferrero Russian write and review the test scripts and participate the unit test, SIT and support the UAT. when in Ferrero project, i also do the cross-board working in Malaysia for about 3 months. And work with consulting team. My responsibility is assure the software quality. In additional, I also deal with the cost and business travel cost of our whole project. Show less

Participate from the software / system development at the beginning, design the test plan, the test case. Integration the system and do black box testing (including functional and performance testing) during the development. Control the quality of the software / system until the official release to customers. Note: In order to improve the quality of software, also participate in the online maintenance of software，resolve the problems encountered by the user during use. Project involved: 1… Show more Participate from the software / system development at the beginning, design the test plan, the test case. Integration the system and do black box testing (including functional and performance testing) during the development. Control the quality of the software / system until the official release to customers. Note: In order to improve the quality of software, also participate in the online maintenance of software，resolve the problems encountered by the user during use. Project involved: 1. Project name: Splashtop OS. Fast response squad to support our OEM(HP, LG) customers for Splashtop OS on netbook or notebook. Response for：SI，test plan&test case design，testing, test report。 Maintain：more than 1 year 2. First 3G Connection Manager for our Splashtop OS. It's a function in Splahstop OS. Response for：SI，test plan&test case design，testing, test report。 Maintain：more than 1 year 3. Splahstop Remote / Splashtop Camcam for individual user on tablet and notebook. C/S app for user to install on tablet or computer, it can control the server by internal or local. Response for：test plan&test case design，testing, test report。 Maintain：more than 2 years 4. Splashtop for business of software for enterprise. It help the employees can control the computer even if them are outside or far from the computer. Response for：test plan&test case design，testing, test report。 Maintain：more than 2 years Show less

Outsourced to Sony to do ST testing of embedded products, primarily responsible for the design Testcase, execution Testcase, bug tracking. This year the work experience I have accumulated a lot of the skills and abilities of the design. Familiar bug management tool(JIRA), perform automated testing tools Testpartner. RUP process we used in the entire project process.

Primarily responsible for the preparation of test documentation, functional testing, use some load testing tool do pressure test and functional testing, a little familiar with bug tracking tool. Training: China Testing Center training. Hope to have better development. Project involved： Integrated system project of the Capital Museum in Beijing.