「臨床數據副分析師II (Associate Clinical Data Scientist II)_Data Management」的相似工作

1. Reads and analyzes protocol, statistical analysis plan, CRF and other trial design documents and discusses with other team members such with as biostatisticians and data managers. 2. Develops and debugs simple to complex SAS program in a timely manner 3. Implements statistical analysis plan, data preparation, and data manipulation into SAS programs and macros 4. Create analysis datasets, statistical tables, figures, and listing for clinical trial data. 5. Create CDISC standard datasets (SDTM and ADaM) 6. Participates in the validation of SAS programs and analysis datasets 7. Maintains documentation for SAS programs and validation results 8. Leads and coordinates the programming work for projects involving SAS programming if necessary 9. Coordinates timelines in orders to fulfill the needs of other departments

We are seeking a Clinical Operations Coordinator to oversee the planning and execution of clinical studies in compliance with GCP/ICH guidelines and company SOPs. This role serves as the primary contact for clinical trial operations and manages day-to-day activities to ensure successful study completion. 1.. Study Oversight & Compliance - Lead planning, execution, and management of clinical studies. - Ensure compliance with GCP/ICH guidelines, applicable regulations, and company SOPs. - Act as the primary point of contact for all clinical trial operational activities. 2.. Team Leadership & Coordination - Manage day-to-day activities of the clinical operations team. - Provide guidance and oversight to ensure timelines, budgets, resources, and quality standards are met. 3.. Cross-Functional Collaboration - Work closely with clinical project managers, medical monitors, pharmacokinetics, data management, regulatory affairs, and pharmacovigilance teams. - Ensure efficient and effective study conduct through cross-functional alignment. 4.. Stakeholder Communication - Communicate study progress to internal and external stakeholders. - Identify and mitigate study risks and issues proactively. 5.. Site & Vendor Management - Oversee investigational sites and third-party vendors to ensure high-quality execution. 6.. Documentation & Systems - Ensure clinical project-related documents and systems are developed and maintained to high standards.

1. 負責資料分析流程執行與優化，協助參與數據應用、資料分析等實際專案執行。 2. 負責維運ETL系統與資料處理、運算等作業，能協助開發/維運資料分析介面。 3. 支援分析資料相關的工作

[職缺條件] 1. 公共衛生、生物統計、統計等相關科系碩士畢業 2. 熟悉臨床資料處理，具備統計概念，具SAS、R等軟體操作能力佳 3. 具備英文讀、寫能力 4. 細心、負責 [職務內容] 1. 執行計畫有關之臨床試驗或研究資料收集工作 2. 執行計畫有關之臨床試驗或研究資料統計分析工作 3. 執行計畫有關之臨床試驗或研究資料之管理 4. 其他主管交辦業務 [應徵方式] 意者請檢附履歷、自傳、學經歷證明文件、碩士論文摘要E-mail至王小姐信箱[email protected]，並請於主旨註明『應徵_職務名稱_應徵者姓名』，符合條件者會通知面試時間。

1.臨床試驗專案的主導、規劃、試驗進度追蹤管理、監督、回報及時程掌控。 2.管理臨床試驗相關費用與合約洽談、簽訂、付款、報帳、時程。 3.確保臨床試驗案符合GCP及相關各國法規。 4.領導跨部門團隊，協調與項目成員合作臨床試驗，案件執行管理等相關工作。 5.監督試驗過程與進度，確保所有步驟都符合GCP標準程序。 6.維護及協助臨床試驗相關文件記錄更新及管理，所有試驗文件檔案需整理並歸檔於部門內TMF。 7.其他臨床試驗相關之主管交辦事項。

1. 獨立執行動物實驗： (1) 熟悉大鼠、小鼠之動物照護 (2) 採血：心臟採血、尾靜脈採血、臉頰採血 (3) 皮下注射、腹腔注射、皮內注射等技術熟練 (4) 小動物麻醉 (氣體麻醉) (5) 能夠辨認大鼠、小鼠臟器，並且熟悉解剖流程 (解剖經驗需要以全臟器為主) 2. 組織萃取與檢體處理 3. 實驗結果整理與實驗紀錄報告撰寫

1. SAS programming for tables, figures and listing. 2. Protocol and synopsis design with statistical methodologies. 3. Project support / Statistical analysis. 4. Sample size estimation and power analysis. 5. Statistical analysis report/plan writing. 6. Communicate with client regarding to statistical issues.

1.協助執行臨床試驗專案管理的書面作業及文書處理。 2.與試驗團隊溝通試驗操作事宜，協助解決問題，確保專案順利推進。 3.設計、準備與管理試驗相關文件，確保文件品質符合規範。 4.協助試驗報告的撰寫、遞交與通報審查單位。 5.處理試驗專案的行政庶務工作。 6.完成主管交辦的其他任務。 7.CRA工作經驗二年以上。

1. 負責臨床試驗專案的推動、管理、醫學評估，包括IND申請文件準備、試驗執行與GCP查核。 2. 協調內部與委外之工作，維持臨床專案品質並有效掌握專案時程。 3. CRO服務的評估、監督、審核及管理，確保其服務品質與合規性。 4. 藥物臨床試驗之法規遵循。 5. 跨部門相關事務之協助及臨時交辦事項。

1.須經常性進手術室裡教導醫師和護理人員正確使用產品 2.協助北區業務進行客戶開發及既有客戶的維持 3.其他主管交辦事項

CRA for BE study/New drugs/Medical devices 1.Clinical research study setup/study procedure setup/site staff training 2.Site monitoring visits/source data verification/deviation reporting in compliance with GCP 3.Trial documents maintenance/regular site visits and maintenance/study materials supply/interim reports 4.regular report to sponsor/communication between sponsor and site. 5.site close-out/trial materials retrieval 6.audits/regulatory inspection participation upon request

- At least 1-year clinical research experience (Oncology is a plus) - Independently responsible for submission, contract negotiation, monitoring, etc. - English ability: frequent verbal/ writing communication

 Work with third party (MOC, Marketing Operation Center) to complete product requested jobs (including Veeva email, Mass email, video, eDetails, Web pages, Print, Webinar Content) in content lab. (60%)  Work with Commercial and MOC team to complete required marketing ankle and reference in content lab. (20%) Assist in communicating and tracking jobs delivery on time (ex: Be able to communicate with contact parts based on planned schedule and actions) (20%)

1. 生體可用率/生體相等性試驗(BA/BE)規劃執行與專案管理 2. 臨床/臨床前試驗與檢體分析(PK/ADA)專案管理 3. 協調整合試驗團隊成員與外部協同合作單位之進度 4. 主導專案起始/規畫/執行/監控/結案分析並進行風險管控 5. 依目標需求控管試驗品質/時程/成本 6. 試驗委託單位聯繫與合約時程經費掌握 7. 主管交辦事項

1. 可獨立與外部單位合作完成田間試驗。包含但不侷限於合作單位評估、相關文件準備、研究單位接洽、執行過程之溝通、結果分析、報告撰寫等。 2. 負責執行公司研發專案所需之毒理試驗、田間試驗所需之相關工作。包含自行執行及委外執行。 3. 負責執行案件中各文件(包含但不局限於試驗計畫書、ICF、CRF、案件送審相關文件)之撰寫、執行中紀錄、數據分析、及報告撰寫等工作。 4. 收集與了解國內田間試驗相關之市場法規需求。 5. 彙整專案執行成果，打造產品臨床開發策略。 6. 公司或組織經營相關之主管交辦事項。

1. Draft, review, and finalize clinical study documents in compliance with ICHGCP, applicable regulatory guidelines, and sponsor specifications, including but not limited to: ▪️Clinical study protocols and protocol amendments ▪️Investigator’s brochures (IB) and IB updates ▪️Clinical study reports ▪️Informed consent forms ▪️Briefing documents for regulatory meetings ▪️Patient narratives and safety summaries ▪️Clinical sections of regulatory submissions (e.g., CTD Module 2.5, 2.7) 2.Ensure scientific accuracy, clarity, and consistency of content across all documents 3.Collaborate cross-functionally with biostatistics, data management, clinical operations, medical affairs, pharmacovigilance, and regulatory affairs teams Interpret statistical and clinical data for integration into reports and summaries 4.Follow internal SOPs, writing style guides, and client-specific templates or standards 5.Maintain awareness of current regulatory requirements and industry best practices in clinical documentation 6.Assist in developing and maintaining document timelines, ensuring timely delivery 7.Respond to quality control or medical/scientific review comments and incorporate revisions accordingly 8.Hold PI meetings, and present protocols and clinical trial results to PIs and relevant personnel 9.Undertake other MA-related tasks as assigned by the line manager

＊⽣物醫學研發資料搜尋、藥物臨床試驗法規評估 ＊新藥開發臨床試驗管理、醫學評估 ＊國內、外新藥臨床試驗申請文件撰寫 ＊其他主管交辦事項

CerbACT Asia provides testing services for both global and local clinical trials. As a perspective member of the Flow Cytometry Department, you are expected to perform routine flow cytometry testing, PBMC isolation, and cell culture, as applicable. You are also responsible for the maintenance of flow cytometers, cell counters, and other related instruments and equipment. You will be working under regulations of the College of American Pathologists (the CAP) and guidelines of the Good Clinical Laboratory Practices (the GCLP) under supervision of Scientist and Department Head. As a member of our team, you will have the opportunity to collaborate with our partner labs in the EU and the US. You will participate in assay transfer validations for cutting-edge flow cytometric assays, fostering your professional development. Responsibilities： - Perform routine lab testing including flow cytometry, PBMC isolation, whole blood pelleting, (ultra)centrifugation, and cell culture, as applicable. - Maintain test results and all related records. - Analyze flow cytometry test results and draft test reports, as applicable. - Schedule maintenance of lab instruments. - Perform incoming material QC of antibodies, including inter-lot and inter-shipment comparisons. - Assist in maintaining adequate laboratory supplies. - Document all tasks performed according to company’s Quality Management System (QMS) and policies. - Participate in regular meetings and discussions and present data internally. - Revise SOPs to improve the workflow. - Any other department tasks assigned by supervisor. CerbACT Asia 為全球和台灣當地臨床試驗提供測試服務。 作為流式細胞技術部門的正式成員，您需要執行常規流式細胞儀測試、PBMC 分離和細胞培養（如果適用）。 您也負責流式細胞儀、細胞計數器以及其他相關儀器和設備的維護。 您將在研究員和部門主管的監督下，按照美國病理學家學會 (CAP) 的規定和優良臨床實驗室規範 (GCLP) 的指南之下進行工作。 作為我們團隊的一員，您有機會與我們在歐盟和美國的合作夥伴實驗室合作。 您將參與尖端流式細胞儀檢測的檢測轉移驗證，以促進您的專業發展。

【工作內容】 ． 使用 Azure Databricks、Data Factory、Data Lake Gen2 等工具建立並維運 ETL 流程。 ． 整合 ERP、CRM、IoT 等多來源資料，進行清洗與轉換並寫入 Azure Data Lake。 ． 與資料科學團隊合作，提供模型所需的資料集與特徵工程支援（如 LightGBM、XGBoost）。 ． 透過Power BI進行資料串接與報表資料結構設計，確保分析資料即時、準確。 ． 撰寫技術文件，維護資料流程運作紀錄與治理機制。 【必要條件】 ． 熟悉 Azure 平台操作（Databricks、Data Factory、Data Lake Gen2）。 ． 熟悉 Python 語言，能獨立進行資料清洗與處理。 ． 具 SQL 查詢能力與資料模型設計經驗。 ． 有與資料科學或 BI 團隊協作經驗，熟悉 Power BI 或其他可視化工具資料串接。 【加分條件】 ． 具備使用 LightGBM / XGBoost 經驗。 ． 熟悉 Git、CI/CD、自動化流程或 Docker 等 DevOps 工具 ． 有 Azure DP-203、DP-100 證照尤佳 ． 英文讀寫能力佳，能閱讀技術文件與跨部門溝通

算法優化，計算生物學，資料分析，計算化學，蛋白質模擬，藥物分子模擬