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

1. Design CRF based on study protocol and prepare the CRF completion guideline. 2. Generate data management plan and data validation plan. 3. Clinical Data Management / Clinical data management status report. 4. Provide training to the site personnel and reporting agencies on proper data collection processes. 5. Coordinate with clinical monitoring activities to help provide prompt feedback to sites on data quality. 6. Establish data quality standards and works with reporting agencies to ensure standards are met. 7. Generate and close queries or apply self evident corrections to the data according to the relevant guidelines.

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

This vacancy is open for talent pool collection. We will contact you if we have proper vacancies that fit with your profile. Job Mission Represent manufacturing and act as gatekeeper from manufacturing to D&E function Add value in overall manufacturing processes such as forming, machining, joining, and assembling Job Description Contribute to the solution of faults and takes the necessary initiatives and practical decisions to ensure zero repeat Identify gaps and drive assigned process improvement projects and successful delivery Initiate and drive new procedure changes and projects Develop and maintain networks across several functional stakeholders Prioritize works and projects based on business situation Transfer knowledge and train colleagues on existing and newly introduced products Education Master degree in technical domain (e.g. electrical engineering, mechanical engineering, mechatronics) Experience 3-5 years working experience in design engineering Personal skills Show responsibility for the result of work Show proactive attitude and willing to take initiative Drive for continuous improvement Able to think outside of standard processes Able to work independently Able to co-work with different functional stakeholders Able to demonstrate leadership skills Able to work in a multi-disciplinary team within a high tech(proto) environment Able to think and act within general policies across department levels Diversity and inclusion ASML is an Equal Opportunity Employer that values and respects the importance of a diverse and inclusive workforce. It is the policy of the company to recruit, hire, train and promote persons in all job titles without regard to race, color, religion, sex, age, national origin, veteran status, disability, sexual orientation, or gender identity. We recognize that diversity and inclusion is a driving force in the success of our company. Need to know more about applying for a job at ASML? Read our frequently asked questions.

工作內容 1. NGS數據分析與報告產出 2. 協助客製化案件分析

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.

[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. 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. 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

誠徵駐部人員，執行衛生福利部委託辦理之「口腔癌防治相關工作」，包含： 1.彙整及分析口腔癌篩檢資料、檢查追蹤結果、費用核撥及協助數據監測。 2.撰寫專案成果報告及相關文件、簡報彙報。 3.提供予客戶相關的執行建議、收納及整理客戶需求並產出相關文件、規劃及辦理會議或課程、製作會議紀錄等，並確保執行進度與品質。 4.專案行政庶務工作及相關聯繫。 5.主管交辦事項。

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. 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

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。

▌Position Description: We are seeking a skilled and motivated R Programmer to join our dynamic team focused on clinical trials. The successful candidate will play a key role in the development, validation, and analysis of R codes and packages tailored for clinical trial data. This position requires a strong background in statistical programming, data manipulation, and a proactive approach to problem-solving. ▌Key Responsibilities: 1. Actively participate in the development of R codes and packages specifically designed for clinical trials. 2. Perform thorough validation of codes and analyses to ensure accuracy, reliability, and compliance with regulatory standards. 3. Independently design, develop, and debug R programs ranging from simple to complex within defined project timelines. 4. Independently implement statistical analysis, data preparation, and data manipulation using R programs and packages. 5. Independently create statistical tables, figures, and listings in R for clinical trial data, contributing to the production of high-quality reports. 6. Create and maintain comprehensive documentation for R programs, validation procedures, and results to facilitate transparency and reproducibility. 7. Collaborate with cross-functional teams, providing programming support and expertise as needed. 8. Assist in the preparation of clinical/RWE study reports, manuscripts, and other scientific documents under the guidance of senior team members. 9. Perform additional tasks as assigned, demonstrating flexibility and a proactive approach to evolving project needs. ▌Qualificaions: • Advanced knowledge of R programming • Strong understanding of biostatistical principles • Highly detail oriented, results driven • Good organizational, interpersonal, leadership and communication skills • Ability to independently manage multiple tasks and projects • Minimum BS (MS preferred) in Data Sciences, Statistics, Mathematics, Computer Sciences or related field. • 1+ years of experience in data sciences or research or drug industry using R. • Experiences in R-shiny, SAS, Python, clinical trials are plus. • Good documentation, communication and organization skills.

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。

加入我們，推動 AI 基因產品創新，改變精準醫療的未來 我們是一家專注於 AI 基因定序與醫療影像分析 的創新科技公司，致力於運用人工智慧解析基因數據，推動精準醫療與遺傳疾病診斷的革新。我們正在尋找 基因產品專案經理，協助規劃並推動基因分析產品的研發與落地，連結生物資訊、AI 技術與市場需求，打造具影響力的創新產品。 我們的團隊秉持 開放、協作、創新 的精神，鼓勵跨領域人才融合基因科學、AI 技術與產品策略，挑戰現有框架，推動基因科技的普及與應用。你將與生物學家、研發團隊、數據科學家及市場專家密切合作，共同規劃、執行並優化 AI 基因產品，確保技術能真正改變臨床決策與生物醫學研究。 主要職責 - 基因產品專案經理 作為 基因產品專案經理，你的核心任務是連結技術與市場，確保 AI 基因產品的開發方向符合醫療與科研需求，並推動產品落地與商業化。你將需要結合 TSO 500 與 Illumina 等生物實驗技術的理解，規劃基因數據分析產品，並管理跨部門協作，確保研發與市場策略的對齊。 你的核心職責包括： - 基因產品規劃與開發：制定產品策略，確保 AI 基因分析技術符合臨床、科研與市場需求 - 數據分析與應用場景設計：與研發團隊合作，將 DNA 基因數據轉化為有價值的臨床與科研應用 - 技術與商業需求整合：串聯生物學家、工程師、醫療機構，確保產品設計符合專業與市場需求 - 市場競爭分析與定位：研究基因定序技術趨勢，制定產品優勢與市場策略 - 產品落地與技術轉化：確保 AI 基因分析技術能在醫療機構或生物研究領域順利應用 - 跨部門協作與溝通：與 AI 研發、數據科學、醫學專家團隊密切協作，確保技術可落地運行 必備技能與條件 - 具備基因定序、TSO 500、Illumina 技術相關背景，了解基因數據分析的流程與應用場景 - 熟悉 AI 與數據分析技術，具備將基因數據轉化為產品應用的能力 - 擁有產品管理或專案管理經驗，具備 2 年以上相關產品規劃與執行經驗 - 良好的市場分析能力，能規劃基因產品競爭策略與定位 - 強大的跨部門溝通能力，能與技術、商業、醫療團隊合作，推動產品落地 - 熟悉醫療與生物科技領域，理解市場需求與臨床應用場景 - 問題解決與決策能力，能在不確定性中推動產品創新與技術落地 如果你熱衷於推動 AI 在基因科學與精準醫療的應用，並希望將技術轉化為真正影響世界的產品，歡迎加入我們的團隊！ 讓我們一起結合 AI 技術與生物醫學，打造下一代基因分析產品，推動精準醫療的革新！

•架構設計與搭建：結合 HIS、EMR、PACS 等醫療系統需求，設計智慧醫院及機器人平台高可用資料庫架構；選型關係型 / 非關係型資料庫，搭建優化集群。 •數據集成與支持：參與數據中臺建設，完成 ETL 數據整合；支持開發團隊設計評審，為科室提供技術諮詢與培訓。 •安全與合規：管控數據訪問許可權，加密敏感醫療數據；配合審計與監管檢查，落實合規整改。 •日常運維與監控：負責資料庫實例、許可權、性能調優；搭建監控體系（CPU、IO 等指標）；制定並執行備份恢復策略。 •技術迭代與應急：評估新技術（雲資料庫、分佈式等），制定升級遷移方案；制定應急預案，處置宕機、數據損壞等突發問題。

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.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。

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

Job Summary As a member of the Central Lab team, you will be primarily responsible for the development, optimization, validation, and testing of Potency Assays based on cellular and immunological principles, as well as ELISA, cell culture, and functional assays. You will help define validation requirements and establish compliant processes under the supervision of the line manager, enabling the Central Lab to successfully develop, validate, and deliver high-quality assays to support clinical trials and regulatory submissions. This role also offers the opportunity to closely collaborate with clinical trial teams as you define and execute the start-up activities required to establish these assay capabilities and technical expertise within the Central Lab. You will lead or contribute to method development, optimization, validation, and transfer of assays, including cell-based functional assays, ELISA, and other immunoassays, while ensuring full GLP compliance. The role involves performing mammalian cell culture, advanced analytical techniques (e.g., Flow Cytometry, qPCR/dPCR), and driving method transfer and validation from external partners. Additionally, you will be responsible for supporting computer system validation, ensuring data integrity, audit readiness, and regulatory compliance across lab operations. General Responsibilities: 1. Collaborate with external groups to identify technology, method evaluation and business processes that will establish potency assay expertise at Central lab. 2. Conduct analytical testing in compliance with established SOPs and relevant guidance. 3. Review data and evaluate against established acceptance criteria. 4. Define requirements for laboratory equipment and support purchasing. 5. Evaluate data to identify trends and/or establish limits. 6. Participant in discrepancy investigations and corrective actions. 7. Provide training to department team member, especially in potency assay techniques. 8. Lead assay development, optimization, transfer and validation activities. 9. Write, review or approve equipment qualification/maintenance life cycle documents. 10.Draft, check, review documents, such as SOP, protocol, analytical result, report and method under limited supervision. 11.Support internal, external, and regulatory inspections. 12.Other tasks assigned by line manager. Qualifications: Education and Experience: 1. Master’s degree in Biotechnology, Biochemistry, Pharmaceutical Sciences, Laboratory Science, or related field. 2. 3+ years of experience in potency assay, ELISA, and/or cell-based assay development, preferably from CDMO, CMO, CRO, or GMP-regulated laboratories. 3. Familiarity with assay development for vaccines, biologics, ADC, or cell therapies is a plus. 4. With direct experience in flow cytometry method development is preferred. 5. Demonstrated ability to apply knowledge of potency assay theories, principles, and techniques. 6. Medical technologist license is a plus, but not required. Skills and Competencies:  Strong expertise in assay validation, method lifecycle management, and data analysis.  Familiarity with clinical trial lab operations and regulatory compliance.  Excellent documentation skills for regulated environments.  Effective communication and collaboration with cross-functional teams and clients.  Strong troubleshooting and problem-solving abilities.  Good verbal and written communication in English.  Ability to manage multiple priorities and meet deadlines in a dynamic CRO setting.