As the regional project representative (RPR) role who is the chairperson of China project team, and accountable for the planning and execution of assigned projects or program from new drug potential assessment, registration, clinical trials to market authorization and post marketing life cycle management. Ensure (with regulatory and/or commercial input) that the development program supports the TPP, satisfies regulatory requirements in China, and differentiates the compound from other… Show more As the regional project representative (RPR) role who is the chairperson of China project team, and accountable for the planning and execution of assigned projects or program from new drug potential assessment, registration, clinical trials to market authorization and post marketing life cycle management. Ensure (with regulatory and/or commercial input) that the development program supports the TPP, satisfies regulatory requirements in China, and differentiates the compound from other treatment options. In collaboration with the core team (CT) members, especially global project development leaders and global project Mgmt leader, provide oversight and direction/suggestions, and be accountable for the translation of project-level strategies into a comprehensive China development plan in global projects. Establish and maintain China project plan including budget, timeline, resource estimations and study drug & comparator drug requirement. Responsible for governance approval (China and global) of project strategy, plan and resource, and providing regular project update to governance body, senior management and stakeholders. Leading China project team to ensure quality and consistent execution of CDP, within agreed-upon timelines.  As ad-hoc CT member, provide strategic input and update to the CT in terms of China development. Show less

Responsible for managing Business operation, System, Process and Training in Servier R&D. As a regional role, my covering countries including China, Korea, Taiwan and Hong Kong.Business operation• Resource and Performance management:✓ Accountable for delivering resource capacity analysis/reports and scenarios analysis, to enable efficient resource capacity decisions✓ Responsible for collaborating with the Finance department to ensure accuracy of cross-charging model for budget… Show more Responsible for managing Business operation, System, Process and Training in Servier R&D. As a regional role, my covering countries including China, Korea, Taiwan and Hong Kong.Business operation• Resource and Performance management:✓ Accountable for delivering resource capacity analysis/reports and scenarios analysis, to enable efficient resource capacity decisions✓ Responsible for collaborating with the Finance department to ensure accuracy of cross-charging model for budget management✓ Responsible for developing department KPI system• Clinical supply and Vendor management✓ Oversights and optimizes the clinical supply process including IMP management, sample management and investigator study files archiving.✓ Vendor selection and ensures their staff is overseen, qualified and able to deliver according to the service agreement in place✓ Accountable for selection and evaluation of CRO’s outsourcingSystem, Process & Training management✓ Guarantee the necessary expertise of CRAs by coaching, training and co-monitoring✓ Ensure that all staff are appropriately trained regarding the Servier global and local procedures and systems✓ Liaising with global counterparts to support the development and drive the Global/Local operation adoption of the IT tools (including CTMS, e-CRF, IWRS, eTMF etc,)✓ Collaborate with all the other countries’ CSSMs to optimize the global process of clinical operation including monitoring, systems and trainings. Show less

• Trial management of 1 pivotal global Phase III oncology trial (22 sites with 137 subjects), 2 sites of this trial passed the FDA inspection on 16-27/Oct/2017 without No. 483 form (no finding).• Participate CFDI inspection as PM role (hematology study)• Oversight trial quality and performance, risk and issue management• Budget plan and contract coordination• Cross-functional coordination for managing project milestone (DBL, CSR stamp for NDA submission, FDA and CFDI inspection,… Show more • Trial management of 1 pivotal global Phase III oncology trial (22 sites with 137 subjects), 2 sites of this trial passed the FDA inspection on 16-27/Oct/2017 without No. 483 form (no finding).• Participate CFDI inspection as PM role (hematology study)• Oversight trial quality and performance, risk and issue management• Budget plan and contract coordination• Cross-functional coordination for managing project milestone (DBL, CSR stamp for NDA submission, FDA and CFDI inspection, etc)• External vendor management to ensure clinical supplies and system are available for all sites.• Working together with global study team for routine study work, issue escalation and resolution• Trial team management, provide training to study team and mentorship to junior or new employee Show less

Trial Experience•3 Phase III Global registration studies (6 sites in all, 1 Prostate cancer & 2 Lymphoma)• Participate two CFDI inspection as lead CRA role (oncology study and immunology study)• Perform site management activities in risk based monitoring model, and in line with SOP and trial monitoring plan● Professional training about Company SOP and system● Established and maintain the good relationship with KOLs, investigators and sites.● Engaged in project support… Show more Trial Experience•3 Phase III Global registration studies (6 sites in all, 1 Prostate cancer & 2 Lymphoma)• Participate two CFDI inspection as lead CRA role (oncology study and immunology study)• Perform site management activities in risk based monitoring model, and in line with SOP and trial monitoring plan● Professional training about Company SOP and system● Established and maintain the good relationship with KOLs, investigators and sites.● Engaged in project support program, assigned as local central monitor role for identifying potential risks at site and study level. Show less

Trial Experience• 3 Phase III Global registration studies (5 sites in all, 1 Breast cancer & 2 Lymphoma)• 3 Phase III Regional registration studies (3 sites in all, 1 Breast cancer & 2 Diabetes)• Perform site feasibility evaluation in pre-study phase• Execute site initiation and training activities for all involved global studies• Perform site monitoring activities in risk based monitoring model, and in line with SOP and trial monitoring plan• Execute site closeout… Show more Trial Experience• 3 Phase III Global registration studies (5 sites in all, 1 Breast cancer & 2 Lymphoma)• 3 Phase III Regional registration studies (3 sites in all, 1 Breast cancer & 2 Diabetes)• Perform site feasibility evaluation in pre-study phase• Execute site initiation and training activities for all involved global studies• Perform site monitoring activities in risk based monitoring model, and in line with SOP and trial monitoring plan• Execute site closeout activities• Established and maintain the good relationship with KOLs, investigators and sites.● Professional training and familiar with of ICH-GCP, local regulation, clinical trial related SOP, System (CTMS, RAVE, OC/RDC, Q-net, ALMAC etc.), Trial monitoring plan and site management skills● Training about Oncology biomarkers and pathology test.● Involved in Buddy program for training new monitor about Roche SOP and system Show less

● Responsible for local SAE submission to health authority and SAE reconciliation with country clinical operation and medical department (all Roche clinical trials)● Triage of the validation and seriousness of individual case safety report (ICSR)● Processing ICSR in company Safety database (Advent/ARISg)● Submission of ICSR to regulatory agency● Professional training of pharmacovigilance related SOP