精睿醫藥科技股份有限公司

1. Protocol, ICF and CRF design and development. 2. CSR and clinical investigator's brochure writing. 3. CTD writing for submission e.g. IND, NDA … 4. Integrated report, annual update, special science report writing. 5. Regulatory GAP analysis. 6. Product evaluation. 7. Scientific literature search, review and information integration. 8. Complete other tasks or assignments requested by the director.

1. 行政文書資料處理及歸檔工作。 2. 電話接聽、信件包裹收發。 4. 協助公文收發及紀錄。 3. 請款單整理、發票開立及辦理核銷事宜。 4. 文具採購彙整及訂購。 5. 辦公室雜費請款(ex.房租、水電費、影印費、文具費、清潔費、快遞費、軟體租用費、電話費、手機費、印名片費用)。 6. 開工、普渡拜拜事前準備及採買。 7. 花籃訂購、會議便當購買。 8. 外包會議場地預定、茶水點心餐點預定、座位及設備安排。 9. 電腦叫修，各別電腦、螢幕租賃及維護。 10. 新進、離職人員資訊申請單開立及資料備份。 11. 名片製作。 12. 更新通訊錄與座位圖。 13. 其他主管交辦事項。

1. 臨床試驗法規審查資料準備與送件 2. 與試驗團隊聯絡及問題之溝通協調 3. 臨床試驗執行與收案進度追蹤 4. 臨床試驗監測與試驗品質控管 5. 臨床試驗相關資料整理歸檔 6. 其它交辦事項

The Associate Clinical Project Manager will manage and support the planning, set up and coordination processes of clinical trials (clinical project management), site management and site monitoring, as well as assist in the optimization of standard operating procedures. Major responsibilities include: 1. Clinical trial project status management: •Including but not limited conducting trial initiation, execution, monitoring, and reporting of clinical studies. •Site budget control and management 2. Quality Control, regulation compliance and monitoring: •Ensuring that trials are conducted in compliance with protocol, ICH/GCP, and applicable regulatory requirements. •Ensure that clinical studies are conducted in a timely and high-quality manner in accordance with protocols, good clinical practice, standard operating procedures, and all applicable regulations governing the conduct of clinical trials •Reviewing monitoring reports and monitoring visit letters written by CRAs 3. Risk identification and Protocol deviation resolving: •Identifying and mitigating potential trial risks •Resolving protocol deviation issues •Support the general running of clinical trials and help overcome any potential issues 4. Communication: •Acting as the main point of contact for sponsors and project teams •Communication and negotiation with suppliers/venders 5. Meeting and conference preparing: •Assisting in the preparation of Clinical Study Reports (CSRs) 6. Training and assisting CRAs in conducting clinical trials: •Working closely with and providing training to study site staff, and junior CRAs •Conducting and/or co-monitoring site qualification, study initiation, interim monitoring, and close out visits and completing associated reports •Reviewing CRFs and data listings for accuracy, overseeing data discrepancy management, and if necessary, coaching CRAs in the development of trial materials and guiding CRAs complete these reports via eTMF system when company requests. 7. Duties of Teamwork: •Creating, monitoring, and sharing key performance metrics with study teams •Performs other duties as assigned by management. 8. Travels as necessary according to project needs.

1. Assist in performing project proposal tasks including drafting budget quotations. 2. Perform administrative management processes, including business document/ file archiving and management, payment processing, and project closure. 3.Meeting coordination and arrangements, assist in project database integration and update project-related master lists. 4. Assist in participating in biotech/medical-related exhibitions and marketing activities, collect and compile client information and conduct periodic client visits. 5. Provide business projects support and perform other tasks assigned by Supervisors. 6. SOP revised and updated by BD director's instruction.

1. 拜訪既有客戶執行業務接洽與管理，提升客戶忠誠度。 2. 依據公司策略，開拓新客戶及市場以達成業績目標。 3. 負責國際客戶及合作夥伴之溝通與協調。 4. 業務承接規劃與可行性評估以及內部資源協調。 5. 專案執行進度之追蹤與協調。 6. 規劃公司業務推動及廣宣活動。 7. 適度參與專案業務之研究與執行。 8. 其他主管交辦之工作。

1. Develop and review the case report form (CRF). 2. Develop and review the database specification. 3. Develop and review the database structure on the database builder. 4. Develop and review the data validation specification. 5. Conduct the database validations including the user acceptance testing. 6. Develop and maintain the CRF library. 7. Develop and maintain the edit checks (ECS) library. 8. Develop and conduct the data review process and dummy data generation. 9. Oversee and coordinate clinical data integration activities as a DMPM. 10. Develop and update the templates of related processes. 11. Develop and manage the working process and standard operating procedures (SOPs). 12. Act as a mentor for the Associate Clinical Data Scientist I 13. Complete other tasks or assignments requested by the Supervisor.

1. Develop and review the statistical Analysis Plan (SAP). 2. Develop and review the Table, Listing, and Figure (TLF) shell. 3. Draft and review the Analysis Data Model (ADaM) specification. 4. Lead and conduct the double-programming for validating the TLF output. 5. Coordinate with the project team and the sponsor for conducting the statistical analysis. 6. Conduct the sample size calculation by program with the Statistics director. 7. Develop and maintain the SAS Macro library. 8. Assist in conducting the data review by program. 9. Mentor and train junior members of the team 10. Develop and manage the working process and draft standard operating procedures (SOPs). 11. Complete other tasks or assignments requested by the Supervisor.