紳詠生技顧問股份有限公司

• 在臨床試驗執行期間，領導和協調統計相關活動。 • 參與試驗隨機開展。 • 根據需要準備或審查臨床研究方案、病例報告表、統計分析計劃和模版。 • 為數據管理活動、符合 CDISC 標準的分析數據集和臨床試驗數據的統計分析創建 SAS 程序。 • 準備臨床試驗報告的統計項目，並向團隊介紹結果。 • 在項目團隊中指導和培養經驗不足的統計學家。 • 擁有並提供對於臨床試驗研究的相關法規和統計方法的理解能力。 • 識別、評估和實施創新的統計方法，為客戶產品臨床開展過程提供建議 • Lead and coordinate statistical related activities to support clinical studies. • Participate in randomization development. • Prepare or review the clinical study protocols, case report forms, statistical analysis plans, and table shells as needed. • Create SAS programs for data management activities, CDISC compliant analysis datasets, and statistical analysis of the clinical trial data. • Prepare the statistical section of clinical trial reports and presentations of the results to the team. • Mentor and develop less-experienced statisticians on the project team. • Demonstrate solid understanding of regulatory guidance and statistical methodology as applied to clinical trial development. • Identify, evaluate, and implement innovative statistical methods to provide added value client drug development process

*在臨床項目負責團隊的指導下執行工作。 *可與臨床試驗團隊合作制定特定研究計劃和/或流程 *進行預研究（機構資格篩選）、啟動、中期監測和結束訪問 *準備試驗機構訪問報告和確認/後續回覆 *根據試驗監測計劃與試驗機構進行定期聯繫並記錄 * 確保數據收集時間表和其成果按照在試驗機構符合試驗計劃內容。 * 與數據管理部門合作處理數據質疑工作 *依據試驗計畫和提交IRB/EC審核過的計畫內容監測試驗機構及辨識和回報試驗偏差。 *確保試驗機構遵守 SAE 報告計畫的每個協議並符合研究計劃 * 確保機構遵守研究協議並遵守臨床試驗相關法規(ICH/GCP)。為研究人員提供適當的訓練。 * 協助執行糾正措施，以解決研究中的不合規問題，包括常規訪視和品質保證審核 *追踪和報告試驗機構的進度，包括受試者篩選/註冊、數據收集、不良事件記錄和處理常見問題。 * 與內部 CRA 或指定人員合作收集、審查和追踪試驗文件，以確保試驗文件和公司中央檔案的完整性。 * 提供持續的研究相關培訓（如 EDC）並在必要時為機構研究人員提供協助 *在試驗機構管理及清點臨床試驗藥物/醫材產品，以及臨床/非臨床用品庫存，並酌情監控退貨文件。 *確保正確收集、儲存和運送實驗室樣本 *參與臨床試驗團隊會議 *協助安全管理部門收集 AE/SAE 文件以進行報告 *與試驗機構保持良好關係並快速解決任何試驗機構問題 *其他交辦事項。 *Performs job with general guidance and direction from our Clinical Project Lead, Clinical Trial Manager, or designees. *May collaborate with the Clinical Trial Manager, in-house CRA, or designee on the development of certain study-specific plans and/or processes *Conducts pre-study (site qualification), initiation, interim monitoring and closeout visits *Prepares site visit reports and confirmation/follow-up letters to sites *Conducts and documents periodic telephone contact with sites in accordance with the monitoring plan *Ensures data collection timelines and deliverables are met at assigned clinical sites in accordance with study plans *Works with Data Management in the query resolution process *Identifies and reports protocol deviations in accordance with study plans and monitors site submissions to IRB/EC per reporting policies. *Ensures site compliance to SAE reporting policy per protocol and in accordance with study plans * Ensures site adherence to study protocols and compliance with ICH/GCP/local regulations at assigned clinical sites. Provides the appropriate training / retraining to the site personnel. * Implementation of corrective actions for addressing non-compliance issues at individual sites and across study, including follow-up to routine and for-cause Quality Assurance audits *Tracks and reports progress of assigned site(s) including subject screening/enrollment, data collection, adverse event documentation, and Frequently Asked Questions * Partners with the in-house CRA or designee in the collection, review, and tracking of clinical trial documents to ensure completeness of both site files and company Central Archive * Provides ongoing study-related training (i.e. EDC) and support to site staff as necessary *Manages Drug / Medical device product and inventory of clinical / non-clinical supplies at assigned sites and monitors documentation of returns as appropriate. *Ensures proper collection, storage, and shipment of laboratory specimens * May participate in Clinical Trial Team Meetings *Assists Safety with the collection of AEs/SAEs documentation for reporting purposes *Maintains good relationships with the assigned sites and works quickly to resolve any site issues and mentoring of new employees as assigned. e.g. co-monitoring. *Perform other duties as assigned by management team.

*與項目團隊合作進行試驗規劃 *依臨床法規設計並撰寫臨床試驗文件，包括但不限於以下文件: 1.臨床試驗摘要， 2.臨床試驗計畫書， 3.主持人手冊， 4.臨床研究報告， 5.INDs, NDAs, MAAs, CER 6.依審查機關意見時效性內進行臨床文件修正。 *法規單位函詢及意見回覆 *學術/臨床文獻資料蒐尋彙整及評估

*在臨床項目負責團隊的指導下執行工作。 *可與臨床試驗團隊合作制定特定研究計劃和/或流程 *進行預研究（機構資格篩選）、啟動、中期監測和結束訪問 *準備試驗機構訪問報告和確認/後續回覆 *根據試驗監測計劃與試驗機構進行定期聯繫並記錄 * 確保數據收集時間表和其成果按照在試驗機構符合試驗計劃內容。 * 與數據管理部門合作處理數據質疑工作 *依據試驗計畫和提交IRB/EC審核過的計畫內容監測試驗機構及辨識和回報試驗偏差。 *確保試驗機構遵守 SAE 報告計畫的每個協議並符合研究計劃 * 確保機構遵守研究協議並遵守臨床試驗相關法規(ICH/GCP)。為研究人員提供適當的訓練。 * 協助執行糾正措施，以解決研究中的不合規問題，包括常規訪視和品質保證審核 *追踪和報告試驗機構的進度，包括受試者篩選/註冊、數據收集、不良事件記錄和處理常見問題。 * 與內部 CRA 或指定人員合作收集、審查和追踪試驗文件，以確保試驗文件和公司中央檔案的完整性。 * 提供持續的研究相關培訓（如 EDC）並在必要時為機構研究人員提供協助 *在試驗機構管理及清點臨床試驗藥物/醫材產品，以及臨床/非臨床用品庫存，並酌情監控退貨文件。 *確保正確收集、儲存和運送實驗室樣本 *參與臨床試驗團隊會議 *協助安全管理部門收集 AE/SAE 文件以進行報告 *與試驗機構保持良好關係並快速解決任何試驗機構問題 *其他交辦事項。 *Performs job with general guidance and direction from our Clinical Project Lead, Clinical Trial Manager, or designees. *May collaborate with the Clinical Trial Manager, in-house CRA, or designee on the development of certain study-specific plans and/or processes *Conducts pre-study (site qualification), initiation, interim monitoring and closeout visits *Prepares site visit reports and confirmation/follow-up letters to sites *Conducts and documents periodic telephone contact with sites in accordance with the monitoring plan *Ensures data collection timelines and deliverables are met at assigned clinical sites in accordance with study plans *Works with Data Management in the query resolution process *Identifies and reports protocol deviations in accordance with study plans and monitors site submissions to IRB/EC per reporting policies. *Ensures site compliance to SAE reporting policy per protocol and in accordance with study plans * Ensures site adherence to study protocols and compliance with ICH/GCP/local regulations at assigned clinical sites. Provides the appropriate training / retraining to the site personnel. * Implementation of corrective actions for addressing non-compliance issues at individual sites and across study, including follow-up to routine and for-cause Quality Assurance audits *Tracks and reports progress of assigned site(s) including subject screening/enrollment, data collection, adverse event documentation, and Frequently Asked Questions * Partners with the in-house CRA or designee in the collection, review, and tracking of clinical trial documents to ensure completeness of both site files and company Central Archive * Provides ongoing study-related training (i.e. EDC) and support to site staff as necessary *Manages Drug / Medical device product and inventory of clinical / non-clinical supplies at assigned sites and monitors documentation of returns as appropriate. *Ensures proper collection, storage, and shipment of laboratory specimens * May participate in Clinical Trial Team Meetings *Assists Safety with the collection of AEs/SAEs documentation for reporting purposes *Maintains good relationships with the assigned sites and works quickly to resolve any site issues and mentoring of new employees as assigned. e.g. co-monitoring. *Perform other duties as assigned by management team.

*藥品/醫療器材之查驗登記、許可證申請/變更及文件撰寫。 *依照相關查登規定及流程，能匯整產品查驗登記資料並確認符合國內外衛生單位要求。 *隨時更新國內外藥事/醫材法規及查驗登記相關規定，確保遵循各國政府法令規定。 *國內外相關資料文獻閱讀及彙整。 *進行海外查驗登記、GMP申請、ISO13485/ISO14791相關事務。 *提供客戶產品查驗登記策略之法規諮詢服務。

*統計部分的臨床協議開發 *樣本量計算 *呈現和解釋統計結果 *審核CSR統計部分 *撰寫統計分析計劃/報告（SAP/SAR） *準備分析計劃並為分析文件、表格、列表和圖表編寫詳細規範及模板 *制定SDTM和ADaM規範 * Clinical protocol development for statistical section *Sample size calculations *Present and interpret statistical results * Review statistical part in CSR *Write statistical analysis plan/report (SAP/SAR) *Preparing analysis plans and writing detailed specifications and shell for analysis files, tables, listings and figures *Develop SDTM and ADaM specification