「Lab Project Coordinator」的相似工作

Please do submit English resume to our company website. https://fa-euzi-saasfaprod1.fa.ocs.oraclecloud.com:443/hcmUI/CandidateExperience/en/job/1488?utm_medium=jobboard General Responsibilities: Manage staff in accordance with organization's policies and applicable regulations, including without limitation: planning, assigning, and directing work; managing performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems; acting as a coach and mentor for subordinates as they develop in their role. Participate in the selection and onboarding process for new staff by conducting candidate review and participating in the interviewing process. Conduct onboarding training for new staff in conjunction with Human Resources and Learning and Development training programs. Ensure that staff have the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan, SOP review and mentored training experiences, as applicable. Maintain lab daily operation. Ensure the quality and timely of lab deliverable. Perform the tasks assigned by line manager. Refer to additional GLP/GCP Regulation Required Responsibilities while involved in GLP organization. As the member of test facility/site management. Delegated /assigned as the system owner for computerized system, do the corresponding work for system, such as validation test, periodic review, report, etc. GLP/GCP Regulations Required Responsibilities (if needed): Lab Manager Maintain an internal responsibility chart which identifies the individual(s) within a test facility who fulfil the responsibilities of management as defined by the Principles of Good Laboratory Practice. Ensure that a sufficient number of qualified personnel, appropriate facilities, equipment, and materials are available for the timely and proper conduct of the study. Ensure the maintenance of a record of the qualifications, training, experience and job description for each professional and technical individual. Ensure that personnel clearly understand the functions they are to perform and, where necessary, provide training for these functions. Ensure that for each study an individual with the appropriate qualifications, training, and experience is designated by the management as the Study Director before the study is initiated. Replacement of a Study Director should be done according to established procedures, and should be documented. Ensure, in the event of a multi-site study, that, if needed, a Principal Investigator is designated, who is appropriately trained, qualified and experienced to supervise the delegated phase(s) of the study. Replacement of a Principal Investigator should be done according to established procedures, and should be documented. Ensure documented approval of the study plan by the Study Director. Ensure that the Study Director has made the approved study plan available to the Quality Assurance personnel. Ensure the maintenance of a master schedule. Ensure that test facility supplies meet requirements appropriate to their use in a study. Ensure for a multi-site study that clear lines of communication exist between the Study Director, Principal Investigator(s), the Quality Assurance Programme(s) and study personnel. Ensure that test and reference items are appropriately characterized. Ensure that appropriate and technically valid Standard Operating Procedures are established and followed, and approve all original and revised Standard Operating Procedures. If necessary, function as Study Director for specific study, in this case, he/she must not have the responsibility of test facility/site management role in the study.

The Researcher is responsible for the conduct of analysis related works according to GCP, GLP, CAP, Standard Operating Procedures (SOP), applicable Study Specific Procedures (SSP), and local regulatory requirements. Manage the operation of MT and aid physicians in the diagnosis, treatment, and prevention of diseases by testing patient specimens, correlating data, and reporting results in a timely manner to effect quality patient care. Responsibilities: Perform analysis work according to SOPs and guidance. Prepare, review, and approve various documents, including SOPs, protocols, reports, and analytical methods. Manage lab logistics, including purchasing, inventory control, and payment processing. Maintain instruments and ensure cleanliness and maintenance of the workspace. Take on the role of system owner for computerized systems, performing tasks such as validation tests, periodic reviews, and reporting. Attend training courses related to CAP/GCP/GLP/regulatory requirements. Study Based Responsibility (if needed) Analytical Study Director in Study Work as the Study Director, responsible for the overall conduct and final report of the study. Approve the study plan and any amendments by signature, and ensure Quality Assurance personnel receive timely copies. Make study plans, amendments, and SOPs available to study personnel. Ensure procedures in the study plan are followed and document deviations and take corrective action if necessary. Document and record all generated raw data. Validate computerized systems used in the study, sign and date the final report to indicate acceptance of responsibility for data validity, and ensure study materials are archived after completion. Study Personnel in Study Ensure personnel are knowledgeable in relevant Principles of Good Laboratory Practice. Provide study personnel with access to study plans and SOPs applicable to their involvement, with a responsibility to follow instructions and document any deviations. Emphasize the responsibility of all study personnel to promptly and accurately record raw data, comply with Good Laboratory Practice principles, and exercise health precautions to safeguard the integrity of the study.

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.

1. 產品技術支援、客訴案件處理 2. 產品行銷規劃執行 3. 產品教育訓練 4. 參展活動安排及規劃 5. 協助公司業務推廣 6. 主管交辦事宜或部門後勤支援

加入我們的專業團隊，開啟您的亞太地區生物科技之旅！ 職缺: 檢體管理員 簡介: 我們是一家位於亞太地區的領先中心實驗室，專注於全球範圍內的臨床試驗相關檢測分析。我們的實驗室擁有GLP和CAP的認證，並致力於提供優質的服務，以支持藥物的科學研究與創新，以造福病友。其中需要檢體管理員這個重要的角色，協同其它檢體管理員們，在臨床試驗中進行檢體管理與處理的所有相關活動，以協助檢測分析的順利進行，同時符合法規等認證需求。不是醫療背景的你，你想穿著白袍在實驗室裡穿梭嗎? 你想對醫療有一份貢獻嗎? 你想要有獨立的辦公座位嗎? 你想要下午有免費的點心吃嗎? 你想要主管時不時請喝飲料嗎? 符合資格的朋友別猶豫了，快來加入我們。 職責範圍: 1. 主要工作: 負責檢體的接收、清點、標籤與核對，並確保檢體資訊的準確輸入至系統中，以及檢體的有效分發。 2. 次要工作: 協助組裝與檢查採檢套組，確保品質管控。 3. 文件管理: 負責案件檢體管理相關文件的掃描與歸檔。 4. 環境維護: 保持檢體管理區域的整潔與有序。 5. 團隊協作: 完成主管分配的其他相關任務。 個人特質要求: 1. 細心與耐心 2. 強烈的責任感 3. 良好的英語能力（多益550分以上、雅思4.5以上或同等水平） 4. 團隊合作精神與良好的邏輯思維 主管寄語：在這裡，我們重視的不僅僅是技能和知識，更看重每位團隊成員的人格與態度。即使您沒有相關經驗，只要有適合的人格特質，我們都願意提供學習與成長的機會。 加入我們，與我們一起推動生物科技的未來！

*此為Adecco外包職缺，合約期間為一年* *歡迎將履歷郵寄至Maggie.huang@adecco.com 【Job description】 This role also needs to manage data platform including customer, performance and digital channels to support data consolidation, alignment and analytics. - Data and platform management and enhancement - Understand deeply of company’s data bases with the capabilities to manage data base with accuracy and efficiency. - Pilot, accelerate and maintain digital channels and platforms to support company data and digital strategy. - Contact window of region or global for platform governance and enhancement. - Data consolidation - Organize, manage, and deliver data consolidation form different sources and platform to provide comprehensive review in support business analytic team. - To generate data in supporting digital engagement performance tracking. - Introduce contemporary data security, data privacy. 【Ideal Background】 1. 1 year experience in analytics or data science in the FMCG/Tech/Healthcare / Biotech/ OTC companies with strong knowledge of statistics, visualization, data preprocessing, and data analytics. Pharma Company is a plus. 2. Proficiency with data mining, mathematics, and statistical analysis 3. Experience with Excel, PowerPoint, SQL, and Power BI. 4. Strong communication and good team player, and able build alignments 5. Strong technical skills, data-driven and result-oriented thinking 6. Fluent in English and Mandarin

1.滿足日常藥物研發需求-取得和提取動物組織，使用放射性標記配體執行受體結合實驗* （*我們實驗室採用高於法規規定的防護策略和徹底的輻射防護訓練） 2.科學創新和重塑** - 根據觀察和研究證據分析和完善工作流程 3.發現新的可能性** - 設計、測試和驗證新的檢測方法和平台 4.建立關係和溝通網絡 - 建立良好的人際溝通能力並與團隊成員合作 5.其他分配的任務 - 設備和實驗室環境的日常維護 ** 碩士學位候選人必須具備 1. Fulfil daily drug discovery demand - acquire and extract animal tissue, execute receptor binding assays with radio-labeled ligands* (*A higher-than-regulation protecting strategy and a thorough radiation protection training are applied in our laboratory) 2. Scientific innovation and reinvention** - analyze and refine the workflow based on observations and research evidences 3. Discover new possibilities** – design, test, and validate new assays and platforms 4. Building relationships and communication network- establish good interpersonal skills and collaborate with team members 5. Other assigned tasks – routine maintenance of equipment and laboratory environment ** Obligatory for Master’s degree candidates

Brief Position Description: The Site Management Associate (SMA) is responsible for planning, directing, and managing clinical trials at site. The SMA also implements remote site management activities according to the Site Management Plan, ensuring that clinical trials are conducted and documented, as per protocol, ICH GCP guidelines and applicable regulatory requirements and SOPs. 工作內容: 1. 協助醫師執行臨床試驗計畫 2. 完成資料及試驗數據之收集、記錄 3. 有研究護理師經驗者佳 4. 計畫及管理臨床試驗 5. 執行試驗場地管理 (依據試驗場地管理計畫) 6. 確保臨床試驗的執行及紀錄，是依據ICH GCP準則、本地及全球性的法規要求、諾佛葛及試驗場地的標準作業程序 Reporting to: As indicated on current organisation chart. Responsibilities: Conduct and complete remote site management activities and/or on-site visits according to the Site Management Plan. Specific duties include: Serve as a primary point of contact for site communication. Implement study start-up activities including but not limited to gathering feasibility information, negotiation of contract and budgets, planning for subject recruitment, communication with IRB/IEC. Collaborate with the principal investigator to prepare IRB/IEC and any other regulatory submission documents as required per protocol, ICH-GCP and local regulations. Ensure amendments to an approved protocol, informed consent form, and other relevant documents are submitted to IRB/IEC for approval as required and assure that changes are not implemented prior to approval. Arrange with monitor the scheduled date, time and location of site initiation visit. Prior to the site initiation visit, review the Investigator's Brochure and any up-to-date information on the investigational product for assessment of risk/benefit ratio of study participation in order to set Site Management Service Plan. Perform study-related tasks delegated by the principal investigator within the contracted scope. SMA is responsible for performing tasks appropriate for its role, unless otherwise noted on a protocol specific delegation of authority log. Support the investigator to identify suitable subjects for screening according to the eligibility criteria. If necessary, assist the principal investigator to use directed and IRB/IEC approved advertising (newspaper, TV, Internet advertisements, posters, etc.) materials. Provide written and verbal site updates on study progress to the line manger according to the study requirements/timelines. Ensure adequacy of information and data contained in site visit reports and other site management documents. Manage the site expenses of clinical trial including but not limited to subject reimbursement, material cost, travelling expense, cost for technical information, utilities and fees.

1.負責HTA評估、諮詢、研究案之專案管理。 2. 其他專案相關工作及交辦事項。 請至本中心網站【加入CDE】專區了解更多職缺訊息： https://www.cde.org.tw/joincde/1409/1999/13531/jobList

【Responsibilities and Primary Activities】 Project ：市場准入公開資訊彙整站／儀表板（Dashboard／Portal） 詳細工作任務：   • 收集公司相關治療領域之藥品於台灣及國際主要市場的上市許可證現況與健保給付狀態，包括申請進度、核准進度、核准條件、市場價格變動等相關資訊   • 更新彙整國內外相關市場准入政策、相關主管機關公告資訊(如專案議題之相關法源規範、醫療預算專款規劃利用、特定治療領域政策重點)   • 搜集並整合指定治療領域之相關藥品公開臨床試驗結果、醫學期刊發表、公開會議記錄或審查結論   • 配合團隊需求，將所有上述公開資訊分類、整理，優化資訊視覺化、查找邏輯及篩選條件，發展一站式可批次更新、查詢與比對功能 (如excel 或dashboard)   • 製作/修訂查詢指引與平台操作手冊，協助同仁有效利用資料 Andy Kuo 郭先生 Direct : 02-7718-8834 Mail : Andy.kuo@adecco.com Line: @527ccida

【主要工作內容】 (一)GMP合規之放射性藥品生產（國際級高防護與高氣密性設備）。 (二)GMP合規之放射性藥品之無菌充填（獨特台灣專利鎢罐保護）。 (三)生產設備及儀器維護保養。 (四)生產記錄報表製作與分析。 (五)撰寫工作相關SOP。 (六)其他主管交辦事項。 ※工作須提重物（10公斤） 【加分項目】若您同時具備以下條件很加分。 (一)具藥廠或無菌製劑經驗尤佳。 (二)具二年以上化學實驗或有機合成相關經驗尤佳。 (三)具「輻射安全證書」尤佳。 (四)具「輻防相關證書」尤佳。 (五)放射線相關科系畢業者尤佳。 【專有的工作津貼與獎金項目】 (一)依工作時間計有夜班津貼。 (二)因應公司發展，執行並完成特別專案則另計專案獎金。 (三)「輻射安全證書」證照加給。 (四)「輻防相關證書」證照加給。 ※普瑞默為與國際知名公司合作建置之藥廠，且有專業輻防團隊駐廠指導，能全方位保障所有同仁輻防安全，我們非常歡迎並期待具備相關經驗或有興趣參與台灣核醫製造的您投遞履歷表，讓我們有機會一起聊聊，以尋求彼此合作的機會。 《加入普瑞默生技，與我們一起挑戰世界》

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.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.醫療器材查驗登記案件審查 2.醫療器材臨床試驗案審查 3.醫療器材研發過程諮詢輔導相關業務 4.其他交辦事項 請至本中心網站【加入CDE】專區了解更多職缺訊息： https://www.cde.org.tw/joincde/1409/1999/13531/jobList

執行公司內部臨床試驗，您將作為 PMS (project management specialist)，根據專案的時程接觸到 CTA/SSU/CRA/RA相關事務 1. 管理及協調CRO、SMO、中央實驗室及研發團隊，特別針對細胞治療專案，追蹤試驗進度與技術需求，並必要時更新實驗室手冊，確保符合GTP及相關品質標準。 2. 負責臨床試驗計畫書變更之FDA及IRB送審，供應商合約簽署與費用管理。 3. 確保試驗藥品及細胞治療產品的供應與使用，必要時更新藥品手冊，並協助監控細胞治療產品的製備、運送及品質控管。 4. 追蹤試驗偏差與不良事件（AE/SAE），協助制定及執行矯正與預防措施（CAPA）。 5. 整理試驗資料與品質控管，確保數據完整並符合GCP、GTP及法規要求。 6. 與跨部門及試驗中心保持良好溝通協調，支持專案管理及問題解決，並配合細胞治療專案的特殊合規要求。

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。 8.文獻查閱及數據整理。

1.國內外醫療器材產品註冊路徑規劃、申請、變更及展延 2.醫療器材註冊技術文件撰寫、維護及更新 3.確認產品（醫療器材）中英文標示、廣告宣稱內容是否符合法規 4.相關法規、標準、證照申請資料之蒐集/彙整更新及維護 5.產品法規相關法規諮詢 (FDA/EU/ISO/ASTM) 6.產品驗證試驗委外測試及規劃 7.協助業務處理國內外客戶與品質、法規相關資料的收集及回覆。 8.協助品質管理系統的認證維護 9.其他主管交辦事項 本職位的重要性在於確保產品品質與客戶需求相符，並能有效地控制成本和風險。此外，該職位可以通過提高產品品質和供應鏈效率來為公司的發展創造更大的價值。 我們提供具競爭力的獎金制度 除年終獎金之外，我們每季將依照績效表現與公司整體盈餘獲利狀況發放獎金，此制度適用於禾寶台灣分公司全體正式員工。

(合作廠商: 生華生物科技股份有限公司) 公司以臨床開發為主、基礎研究為輔，致力於小分子抗癌新藥的研發，專注在「市場首見(first in class)」抗癌新藥開發，在資金、營運、智財、藥物合成、藥物製劑、動物試驗及臨床試驗等等管理之經驗豐富，隨著臨床試驗由一期進入第二期及三期，以及開發新的適應症應用，整合完備的資源，能提供合宜的培訓需求。 JD職缺說明: 職稱: 臨床前研究實習 • 具有規劃、管理及執行臨床前試驗/或是臨床試驗之能力。 • 具備基本分子生物實驗技術。 • 了解如何設計良好及合適的動物試驗，以充分了解試驗藥物的潛在風險和益處。

1. 臨床試驗的規劃與執行，包括臨床試驗流程監控、Phase 1 臨床數據分析、Phase 1/2 & Phase 2 試驗設計所需之背景資料收集與解讀。 2. 規劃並推進 長效針劑產品 BE study，包含CRO選擇、資源配置與時程管控，確保與整體 研發計畫一致。 3. 進行臨床數據與 藥理/藥代（PK/PD）分析 之審查與解讀，並撰寫醫學與科學報告，以支 持法規申請與內部決策。 4. 協助安全性監測（SAE/AE 評估、signal detection）與真實世界/背景數據分析，確保受 試者保護與醫學合規性。

工作內容 1.Prepare and customize the Informed Consent Form. 2.Organize translation/verification of document required for clinical trial submission. 3.Planning the clinical trial submission timeline. 4.To be responsible for preparation of TFDA/IRB submission, including the comment reply until obtaining TFDA/IRB approval. 5.To be responsible for preparation of Interim report submission and Final report submission, including the comment reply until obtaining TFDA/IRB approval. 6.Apply for IP IL permit, infectious sample export permit, NCC application for 3C device import/export. 7.Good communication with study team, manage TFDA officer and IRB staff to meet the submission timeline, and propose the resolution to the client 8. Planning the clinical contract budget and negotiate with site clinical research center to fast the CTAg execution. 9. Familiar with TFDA/IRB requirements to support the team and answer the regulatory questions from the client. ＊無經驗可，公司會進行工作技能相關訓練課程。 ＊有實際做過TFDA /IRB送審工作，且兩年以上工作經驗者優先錄取，待遇從優。