華鼎生技顧問股份有限公司

Job Responsibilities: 1. Development of clinical study report (CSR). 2. Assistance in development of clinical study protocol (CSP), common technical document (CTD), investigator’s brochure (IB), and master informed consent form (ICF). 3. Development, QC, and review of trial related documents. 4. E-Publishing (M5). 5. Preparatory activities for consultations and meetings with regulatory/CDE/TFDA/US FDA. 6. Preparation and attendance of project meetings and sponsor meetings. 7. Medical review of clinical trial coding and safety data. 8. Perform other company-related duties assigned by the supervising manager. **Education/ Qualifications: 1. MSc, PhD, or MD degree in life science/pharmacy/medicine with a minimum of 2-year experience in clinical research or in medical/scientific writing. 2. Quality-oriented, accurate, detail-oriented, and responsible working attitudes to provide deliverables in a timely manner. 3. Self-motivated, flexible, creative, able to prioritize, multi-task, and work in a fast-paced and demanding environment. 4. Good inter-personal skills and time/project management skills. 5. Good written/oral English and Chinese and other required language skills. 6. Familiar with GCP principles and related ICH guidelines. 7. Good medical/scientific writing and ability to adapt style/content to different readers/audiences. 8. Good editing and QC skills. 9. Good computer skills, including MS Office, PDF formats, scientific graphing. 10. Ability to search different databases, e.g., PubMed.

工作內容 1.Develop budgets, proposals, and other related documentation for QPS domestic and global multisite and CRO clinical research activities. 2.Maintain compliance with Global Proposal Office processes, standards, guidance documents, templates, instructions from the line manager and Head of the Global Proposal Office, etc. 3.Effectively identify, communicate, and escalate issues, concerns, and feedback to the line manager on an on-going basis and in a timely fashion. 4.Communicate internal timelines and meet/exceed timeline commitments. 5.Provide regular updates and activity reports to the line manager and, as requested, the Head of the Global Proposal Office. 6.In accordance with Global Proposal Office scope and processes, accurately organize, file, and name information and update and manage information in SalesForce.com or other data capture system. 7.Process awarded projects in accordance with Global Proposal Office processes. 8.Prepare and assist in negotiations of assigned proposals/work orders, amendments and change orders and follow through to execution as required and escalate as appropriate. 9.Assist with creation of initial study timelines in cooperation with Global Proposal Coordinators, Clinic. 10.Contribute to team and departmental initiatives outside of day‐to‐day activities. 11.Other duties as requested or assigned by supervisor. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. 12.需兩年以上proposal coordinator 經驗或CRO 相關行業經驗 13.若有需求，可約40%時間居家工作。

1.Experience in SDTM dataset, and ADaM dataset for FDA submission 2.臨床試驗資料統計分析 包含 PK analysis and Clinical analysis (PFS, OS..and so on) 3.熟悉SAS 程式 (Macro,glm..end so on.) 4.英文撰寫能力佳者 5.Develop and modify the statistical methodology. 6.Resolve malfunctions of SAS programs to ensure optimal analysis performance.Sample size and power estimation. 7.Design randomization schema. 8. Write the statistical analysis plan: detailed written specifications of statistics, tables and graphic displays. 9.Evaluate, analyze and report study data with expert statistical method: from routine t-tests to leading-edge, just-published methods. 10. Interpret statistical results and complete the statistical section of clinical trial report. 11.Conduct database lock, unlock, un-blinding process and data transportation process. 12. Conduct computerized error detection - “electronic edit checks”. 13.Produce simple tables and figuring in line with demand of statistical analysis and SAP specification. 14.Subject data listings generation. 15.Sample size and power estimation.

• Perform regular site visits to ensure that the site personnel are conducting the study in accordance with the protocol and ensure that any issues arising from the visit are documented in a visit report and addressed with the site in a timely manner. Any concerns or ongoing issues should be escalated to the Project Manager or Clinical Research Manager, as appropriate. • Perform feasibility study survey to identify the potential sites or strong the business opportunity. • Prepare and submit respective visit report in a timely manner after every site visit. • Communicate with investigators to obtain necessary documentation and information before, during and after the study on an ongoing basis, to met quality requirements of central and investigator site files. • Support RA team by collecting investigator site regulatory documents for regulatory and ethics committee/IRB submissions. • If appropriate, assist in generation of Clinical Trial Agreements according to standard and local country practices, and assist the sites in agreement completion prior site initiation. • Initiate investigational sites to ensure that they have a complete understanding of the clinical protocol and that they could abide by their obligations to conduct a clinical trial as required by applicable regulations.

⚫Design CRF/eCRF and write CRF/eCRF guideline. ⚫ Rule test of EDC system. ⚫ Assure correctness of data captured in CRF in accordance with protocol specifications and GCP guideline. ⚫ Write validation plan as a rule of query issuing. ⚫ Create and issue the DQF and DCF to clarify any inconsistent or uncertain data recorded in CRF. ⚫ Check the data inventory and track status of every CRF/eCRF page and query. ⚫ CRF/eCRF correction according to the resolution from DQF and DCF. ⚫ AE and/or Medication coding. ⚫ Confirm the resolution of data issues for database lock.

1.協助醫師執行臨床試驗 2.其他主管交辦事宜

1.協助醫師執行臨床試驗 2.其他主管交辦事宜

1.協助醫師執行臨床試驗 2.其他主管交辦事宜

1.協助醫師執行臨床試驗 2.其他主管交辦事宜 3.需至各家醫院做臨床實驗

1.協助醫師執行臨床試驗 2.其他主管交辦事宜

1.協助醫師執行臨床試驗 2.其他主管交辦事宜

1.協助醫師執行臨床試驗 2.其他主管交辦事宜

1.協助醫師執行臨床試驗 2.其他主管交辦事宜

1.英文資料KEY-IN,需具備英文讀、寫能力。 2.Conduct pCRF and query form log-in process. 3.Conduct data entry. 4. Flag any outstanding data entry issues for review. 5.Check and filing all the pCRF and query form. 6.Conduct documentation filing of data management and biostatistics files. 7.Assist the CRF database test. 8.Assist the rule test of EDC system. 9.Assist the rule design (Real-time edit check upload) of EDC system. 10.Assist generate the script and/or check the script for database testing.

1.協助行政事務(如文件影印與裝訂, 資料彙整, 聯絡試驗單位並收集所需文件, 申請付款/繳費等事宜) 2.協助送審文件準備 3.處理主管交辦事項 4.需具原住民身份