Katharine sun

Manage staff in accordance with organization's policies and applicable regulations, including without limitation: planning, assigning, and directing work; managing performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems; acting as a coach and mentor for subordinates as they develop in their role. • Direct the hiring and selection process for new staff by conducting candidate review through participation in the interviewing process. Establish methods to develop and evaluate onboarding processes. • Develop standard processes to ensure that staff has the proper materials, systems access, and training to complete job responsibilities. Oversee the execution of the training plan, SOP review and mentored training experiences. • Support customer audit and regulatory inspections • Ensure that there is a Quality Assurance Programme with designated personnel and assure that the quality assurance responsibility is being performed in accordance with Principles of GCP and regulatory requirements. • Lead and/or support internal audit activities • Lead or support in the investigation and evaluation of quality events (CAPA's, issues, complaints), incidents and follow-up activities • Participate, review, and approve documents for validation activities for any GxP computerised systems

es: • Accountable for establishing and enhancing quality management system, including SOP developing, implementation, documentation system, training program to assure adherence to GCP and relevant regulatory compliance lities CURRICULUM VITAE • Leadership in developing quality assurance strategy to support QA activities, e.g. audit, inspection readiness, to assure adherence to SOPs, GCP, sponsor requirements and any applicable regulatory requirements • Accountable for QA team talent management and developme

• Ensuring annual QC plan is developed and aligned with China Evidence Generation Head. • Leading QC team to delivery responsibilities as QC plan defined. • Reviewing and implementing Global and regional Procedural Documents. • Developing, implementing, and maintaining local Procedural Documents and processes. • Picking up and categorizing SOPs, templates applicable for local EvGen study team. • Organizing training to the department to emphasize the procedural key points and the update according to GCP and relevant SOPs. • Assuring China MA Evidence Generation is ready for audit and inspection at any time. • Conducting quality control checks in clinical studies as agreed with local clinical study team leaders. • Completing other emergency tasks as required.

Drive GCP and PV quality both in strategic vision and personal tactical execution, ensuring that projects and deliverables are compliance with EU, China and ROW( Rest of World) requirements； • Accountable for establishing and enhancing quality management system, including SOP developing, implementation, documentation system, training program to assure adherence to GCP and relevant regulatory compliance. • Leadership in developing quality assurance strategy to support QA activities, e.g. audit, inspection readiness, to assure adherence to SOPs, GCP, and any applicable regulatory requirements • Implementing a local pharmacovigilance system for all the products and ensure compliance to local authorities is maintained. Maintain a functional connection with the EUQPPV for Pharmacovigilance, Development and revision of local PV procedures • Maintaining oversight of local deliverables delegated to service providers. • Develop the strategic and annual audit program according to requirements of the GVP Module IV, to verify the appropriateness and effectiveness of the PV system, performing PV audits.

• Associate Director of QA is responsible for leading the development of an annual Quality Assurance Plan (QAP) and audit schedule • Escalate issues and concerns to management in a timely fashion and keep the person to whom the reports informed of any QA issues within the department/office that require attention • Liaise with clients/sponsor and clinical development team on quality/compliance aspects of studies including the attendance at marketing meetings, project meetings, oral presentations, and audits/inspections • Support EPS INTL clinical development team to facilitate overall readiness and responsiveness of clinical operations for sponsor audits and regulatory inspections • Support the vendor qualification survey and participate in the assessment of vendor qualification to provide QA aspect inputs for vender selection and partnerships decision • Continuous Improvement on efficient quality awareness in execution of clinical trials and adherence to applicable standards and regulations • Proactively develop and maintain the EPS International quality systems and procedures, in line with changes in laws, standards and regulations and to ensure process improvements. • Serve as a GCP Subject Matter Expert, input on cross-functional teams developing Quality Management Systems, Policies, SOPs materials

● Unit ensuring high quality, timely and cost-effective conduct of all clinical trials in accordance with local regulations, Declaration, GCP and SOPs • To lead and guide, coach, and provide ongoing feedback to Project team members. • Prepare resource forecasts and ensure timely resource allocation for allocated clinical trials. • Ensure best utilization of available resources to reach reasonable productivity. • Responsible for recruiting staff with good knowledge, skills, experience and fit for project management. • Evaluate operational effectiveness and identify and implement best practices. • Forecast and properly execute Clinical Operations Unit budget to minimize costs. Identify mechanisms for improving cost efficiency. Provide oversight and reviews for trial budgets. • Drive and implement improvements in key performance indicators and quality. Leading the development, adaptation and implementation of processes and systems necessary for the effective conduct of clinical research

Lead and Manage the team of 21 CRAs • Manage and develop employees to ensure high quality work performance and retention of high-quality employees. • Develops plans to support growth and career development of assigned Clinical Operations Employees as well as manage the delivery of quality performance in line with their job description. • Responsible for managing the performance of staff, including providing input into salaries, bonuses as well as nominations for promotion. • Responsible for the management of resources and resource projections to ensure project teams are consistent with client needs expectations and contractual expectations. • Schedules and reviews project task provides leadership in the delivery of services to clients. • Maintaining utilization of all Clinical Operations employees within department goals • Identifying and implementing process improvements through review of clinical operations SOPs, processes; recommending improvement plans to senior management.

---Complete one CAP phrase III regional study and one PK study in parallel to phrase 3 ----Managed one anti-hypertensive agent global phrase III study from protocol design to CSR final, fulfilling the CFDA supplement requirements meeting high expectations of the entire company. ----Planning one oncology PK study • Manage CROs and SMOs to deliver key clinical operation milestones. Ensure studies are effectively executed and completed within budget, timelines, and meeting enrolment commitments. • Manage Study Statistician Report (SAR) and Clinical Study Report (CSR) writing, interactions with the medical writer, statistician to ensure report is completed with high quality according to milestone. • Provide clinical input to IND dossier. Produce essential documents including the authoring of protocol, ICF • Ensure the set up and maintenance of the Trial Master File (TMF). Ensure essential documents appropriately archived and paper TMF physically transferred to the central archive at the end of the study • Communicate study progress with Japan sub-team to seek high-level advice and guidance. To confirm/discuss site management issue, to discuss study issue, to inform study status • Oversight of CRO/SMO management supervise Project Leaders assigned to project teams. Identify sites and manage study start up, duration to site closure • Track, oversee and manage to budget including investigator grants, lab costs, vendor costs, clinical supplies, and investigator meeting costs variance from CRO fee, pass through and investigator fee budget. • Responsible for the coordination of pre-audit activities ensuring a satisfactory outcome is achieved and address corrective actions. • Organize, develop, and chair investigator meeting, prepare meeting materials

Performed general role as CRA ( 2 Gastric cancer global Phase III studies, 1 Bone Metastasis from solid tumors regional Phase III study , 1 COPD China registration study) with additional but not limit to following responsibilities: • Act as a mentor for CRAs by demonstrating the role of an experienced CRA in the preparation, conduct and reporting of all clinical monitoring functions. • Assist in developing project specific training for the clinical project team of the assigned clinical trial where necessary. Provide input in performance appraisals/reviews as requested. Assist project manager/clinical team manager in developing study tools/documents, tracking and monitoring forms. • Demonstrate problem-solving techniques applicable to constantly changing environment. Participate in the design and development of patient informed consent templates and other protocol specific documents as required. • Assist with in-house review of CRFs, query writing and query resolution, CRF tracking, and act as a liaison with Data Management division for specified study. • Assist with generation and tracking of Investigator and site payments according to contract/client budget, as required. • Monitoring sites from site selections, initiation, execution and close out.

• Manage the clinical study set-up & follow-up start up activities through ongoing tracking & review of study progress. Report progress to clinical management & project management forums • Collaborate with other functional groups (such as data management & pharmacovigilance) & other third parties (such a laboratories & investigational product supply & distribution) as appropriate to support milestone achievement & to manage study issues & challenges. • Provide ongoing training & support to the clinical team. Establish study tools & training materials. Conduct frequent team meetings & ensure regular communication. • Ensure high performance & efficiency of the clinical team through the scheduling of co-monitoring site visits & ongoing mentoring of the CRA team. • Develop the risk management plan from a clinical perspective & coordinate clinical issue escalation & resolution. • Track clinical budget consumption.