Lujie Wang

General Management: 1) People development for direct reports, perform performance review with direct reports, discuss and approve development plan for direct reports. 2) Overview project management quality and process for direct reports; Support direct reports on project management and site management. 3) Review clinical research SOP and provide input on SOP revision. 4) Provide training and guidance to junior team members and business partners. o Project Management: 1) Set up and lead the project team to ensure the study is implemented according to company policy, SOP and relative regulations. 2) Lead the project team to accomplish the proposed timeline. 3) Communicate with internal and external customers in terms of project progress and outstanding issues. 4) Lead the protocol design and approval process, provide scientific and feasibility input on the protocol and other study documents design. 5) Evaluate the potential investigational sites for a specific study in terms of the quality of the investigator and the suitability of the sites. 6) Prepare study budget proposal based on fair market value. Ensure the study is operated according to the budget. 7) Actively guide and coach CRAs in the study team. 8) Coordinate with data management, statistician and medical writer to generate the statistical report and study report. 9) Evaluate the CRO, provide evaluation assessment to line manager. 10) Perform co-monitoring to team members.

• Accountable for managing overall study timelines, budgets and quality targets for both drug and medical device; o Plan, manage and monitor clinical studies effectively in compliance with ICH-GCP, ISO etc. relative regulatory guidelines, clinical trial plans, company SOPs, study timelines and inspection readiness; o Lead site selection, initiation, monitoring and close-out visits if applicable; • Select, oversee and manage CRO and other third-party vendors; o Monitor progress against plan; develop and implement formal operational risk management plans across the asset/program. Accomplish projects on time with high quality; • Involve in the clinical development operational strategy, trial planning, and study/protocol design. Provide clinical operation inputs to the study design, protocol and company portfolio; • Develop recruitment strategies to increase patient enrollment; work with sites/CROs to adapt, drive and track subject recruitment plans if applicable; • Make the trial documents required by applicable regulations filed and archived properly with all contents;

• Strategical plan, direction and support to business/strategic development initiatives for the designated medical device and diagnostics customer in terms of regulation and market access in APAC. • Manage a designated medical device and diagnostics customer account globally to provide leadership oversight to customer and IQVIA assigned project teams and lead the development of and adherence by all project teams to an operations manual specific to the designated medical device customer account for all product development projects. • Team member responsible for the development of designated medical device and diagnostics customer tools and operating principles. • Ensure the delivery against key metrics, milestones, and contractual obligations for a portfolio of projects to encompass expectation setting and management against quality, time and financial objectives (e.g. project & portfolio margin targets). Take PM role when necessary. • Be as primary contact with select customer contacts to ensure appropriate communication channels are maintained and reporting schedules adhered to. • Review the customer pipeline, opportunities pending, and future customer needs in support of the quarterly development of resource forecasts for delivery to the cost centers providing resources to the customer's account (e.g. project management, QLAB, data management, clinical operations, biostatistics, etc). • Participate in sales/proposal presentations in face-to-face meetings with potential clients.

• Strategical plan, direction and support to business/strategic development initiatives for the designated medical device and diagnostics customer in terms of regulation and market access. • Manage a designated medical device and diagnostics customer account globally to provide leadership oversight to customer and IQVIA assigned project teams and lead the development of and adherence by all project teams to an operations manual specific to the designated medical device customer account for all product development projects. • Team member responsible for the development of designated medical device and diagnostics customer tools and operating principles. • Ensure the delivery against key metrics, milestones, and contractual obligations for a portfolio of projects to encompass expectation setting and management against quality, time and financial objectives (e.g. project & portfolio margin targets). Take PM role when necessary. • Be as primary contact with select customer contacts to ensure appropriate communication channels are maintained and reporting schedules adhered to. • Review the customer pipeline, opportunities pending, and future customer needs in support of the quarterly development of resource forecasts for delivery to the cost centers providing resources to the customer's account (e.g. project management, QLAB, data management, clinical operations, biostatistics, etc). • Participate in sales/proposal presentations in face-to-face meetings with potential clients.

• Supports strategic planning, direction and support to business/strategic development initiatives for the designated medical device customer. • Support the management of a designated medical device customer account globally to provide leadership oversight to customer and Quintiles assigned project teams and lead the development of and adherence by all project teams to an operations manual specific to the designated medical device customer account for all product development projects. • Team member responsible for the development of designated medical device customer tools and operating principles. • Support the delivery against key metrics, milestones, and contractual obligations for a portfolio of projects to encompass expectation setting and management against quality, time and financial objectives (e.g. project & portfolio margin targets). • Serve as primary contact with select customer contacts to ensure appropriate communication channels are maintained and reporting schedules adhered to. • Support efforts to review the customer pipeline, opportunities pending, and future customer needs in support of the quarterly development of resource forecasts for delivery to the cost centers providing resources to the customer's account (e.g. project management, QLAB, data management, clinical operations, biostatistics, etc). • Participate in sales/proposal presentations in face-to-face meetings with potential customers.

•Vendor Management: New Vendor selection: New vendors adding into Clinical Approved Vendor List (C-AVL). Contact vendors for initial intensions. Distribute CDAs to vendors for signatures. Upload fully executed CDA into GEP system. Draft Request for Proposal (RFP) delivery to new vendors and follow up with vendors for online inputs. Work with Global Clinical QA department for completing CQA forms. Analyze based on the completed RFP. Organize bid defense for the new vendors. Feedback collection from functional stakeholders such as PM, Operation Manager, DM. Generate Master Service Agreement (MSA) and sign with selected new vendors. Upload the fully executed MSA into GEP system. System management and maintenance for vendors. Vendor oversight: performance management on C-AVL vendors. Maintain vendor issue log. •Internal and external Training Coordinate: Internal SOP/WI training: present all Site Start-up related SOPs/WIs. Coordinates and assists with the development and/or maintenance of Clinical infrastructure such as the drafting or reviewing SOP’s and Work Instructions. •Mentor new team members and give necessary SOP/WI and study related trainings. External training: plan, prepare, and distribute materials for investigator and coordinator meetings, and for study-related training. •Clinical Study Agreement, budget consolidation and definition, ICF and CDA: Study level contract and budget finalization. ICF – Trial / Site Specific Development (country and site customization). CDA template generation and issues negotiation with global and local legal when necessary. •CRA: Core Team Member as lead CRA. 

• Manages distribution, collection and tracking of regulatory documentation to ensure compliance at both the sites and Sponsor Central File. • Assists in planning, preparing, and distributing materials for investigator and coordinator meetings, and for study-related training. • Assists with the development and/or maintenance of Clinical infrastructure such as the drafting or reviewing SOP’s and Work Instructions. • Core Team Member – ensures supporting CRA’s and CTS’s are aware of specific study needs • Provides Trial Operations metrics to project teams • ICF – Trial / Site Specific Development (country and site customization), Negotiation and Coordinate Approval • Site Selection – Send/Receive Site Selection documentation to sites • Completion of Study Master File Index (SMFI) • Documentation – Request / collection of relevant (i.e. Regulatory Docs, FDF, CV/ML) investigator / site documentation, review and approval of subset of documents in CDC • Manage Authorization to Enroll process • Collaborating with BAA to maintain contact information and staff changes in CTMS • Quarterly review of MUL • Primary in-house point of contact for sites • Provides on-call help for sites • CSA / Budget negotiations and executions (including amendments) • IRB/EC/CA registration, renewal and maintenance • Coordinate with appropriate functions for content development of Trial Support Material Generation • Study close-out activities • Participate in or leads CRA activities

• Maintains current regulatory documentation according to Essential Document Review Guidelines (EDRG), Trial Master File (TMF) Plan or other sponsor-approved guidelines. Reviews and submits Essential Regulatory Documents for second review. • Assures compliance with CFR, state regulations, ICH and GCP guidelines, INC Research and sponsor SOPs and Work Instructions (WI). • Drafts and prepares start-up and regulatory documents for mass dissemination coordinates shipment of initial regulatory packages and arranges for receipt of regulatory documentation. • Attends project team meetings and clinical training sessions according to the project Communication, and/ or Training Plans. • Coordinates with study teams, sponsors, site contracts and/or other functional areas on the priority and processing of documents leading to investigational product release and the timely activation of investigator sites. • Utilize designated clinical trial management system to track and process clinical trial information, e.g., Regulatory documents, IRB re-approvals, protocol amendments, etc. • Communicates key study performance indicators to Project Team members. • Reports and tracks outstanding regulatory documentation. • May provide input for status reports for internal and external customers. • Assists in preparation for and may attend investigator’s meetings and Trusted Process meetings (including Kick-Off Meeting and Quick Start Camp, as needed). • Assists with informed consent form (ICF) development, review, negotiation and approval processes. • Assists with review and approval process for patient recruitment materials. • Clinical trial contract budget, template generation and contract negotiation with sites

• Actively managed new drug clinical trials as a project assistant completing tasks not limited to but including document filing, sending documents to sites, with close communication to site monitors and site managers. • Effectively navigated Bristol-Mayer Squibb special systems and softwares (e.g. ESF, IMPACT, CEPAS, BPCS etc.) For payment transactions from vendors. Defined role as a ‘System Specialist’ of IMPACT, GID, CMW, etc. • Matrix Corporation with other related staff during projects proceeding. Site managers (STMs), site monitors (SMNs) and clinical trials associates (CTAs) work together on a project. CTAs are responsible for in-house CRAs work. A CTA will follow one specific project from the very beginning till it ends, which goes through Site Start-up phase, maintenance, and site close-out. • Liase and collaborate with third party vendors to make arrangements for drug importation from global clinical supply organization. • Facilitated cross-department communication (e.g. Finance department; Global Purchase department) on dealing with some significant simplification and improvement about processes and management of vendors. • Point of contact for translation assignments and implementation for all study teams as a coordinator between BMS and translation vendors. • Mentor new CTAs