Phase: I-IIIResponsible for the company's key clinical trial as an APM; Independently undertook the full-process management of the formulation project and the Phase I clinical trial (diabetes), The projects were completed ahead of schedule by one and three months respectively. Responsible for managing the Phase III trial’s (psoriasis) 60% of the sites, enrolling 70% of the total subjects and completing the enrollment task two months ahead of schedule. 1. Responsible for the sites’ screening, initiation, etc and confirming the qualifications of the sites and investigators;2. Responsible for the selection, negotiation, and contract drafting of suppliers;3. Management of external suppliers, such as SMO and CRO;4. Proofreading and revision of operational documents, such as protocol, CRF, etc;5. The management of trials’ material, payment, expense, etc;6. Management and teaching the company's internal CRAs;7. Assist in the construction of the company's CQMS;8. Writing and revision of the part of clinical operation SOP;9. Responsible for the planning, promotion, management, quality control, etc.

Indication: NSCLC/Thrombosis/Immune rejection reaction/Macular edema/Overactive Bladder/Regional enteritis/Esophageal cancerPhase:III and IVResponsible for clinical trials’ operations in China for many global pharmaceutical companies such as BMS, Roche, Astellas, and Takeda. During my tenure, I received numerous praises from clients and internal recognition for my excellent performance.1. Perform site selection, initiation, monitoring and close-out visits by the contracted scope of work and good clinical practice.2. Accountable for supporting the development of project subject recruitment plan on a per-site basis. Work with sites to adapt, drive and track subject recruitment plans in line with project needs to enhance predictability.3. Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.4. Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.5. Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support the start-up phase.6. Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.

1. Conducted site initiation, monitoring visits to site's close out.Sites includes Changhai, Zhongshan Hospital, etc.