「臨床專案管理專員 (Clinical Project Management Associate)」的相似工作

1.進行動物醫院臨床訪視。 2.負責臨床相關試驗專案管理，進行對外說明公司產品特色簡報製作並回覆相關動物臨床用藥問題。 3.動物臨床法規查找、主管機關諮詢及審查文件研擬送件。 4.協助癌症新藥開發規劃及協助市場銷售專案。 5.其他主管交辦事務。

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. 管理與追蹤臨床受託研究機構(CRO/SMO…)公司、醫療機構之專案。 2. 管理與追蹤臨床專案執行品質、文件整理。 3. 落實臨床專案相關文件(計劃書、GCP…等)之設計、審閱與歸檔。 4. 協調臨床試驗相關事宜，加速臨床試驗進程。 5. 協助及配合臨床試驗監測與稽核。 6. 執行主管交辦其他事項。

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。

執行試驗起始活動、試驗合約與經費協調、試驗文件與工具管理、試驗監測訪視、參與試驗各式會議、試驗進度追蹤與管理、執行試驗關閉訪視、協助試驗稽核與查核等等。

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.

將依照過去經歷進行職稱及職等核定 臨床專案副理 工作內容: 1.臨床試驗專案主導、計劃與管理 2.撰寫臨床試驗計畫書 3.準備臨床試驗申請TFDA/US FDA之相關文件 4.協調、聯繫臨床試驗法規單位FDA，CDE 5.協調、聯繫醫院臨床試驗團隊與CRO 6.監測臨床試驗之進行 7.管理臨床試驗專案費用與時程 臨床專案專員(CPS) 工作內容: 1. 協助專案經理進行臨床試驗專案管理與進度推動 2. 協助醫院端費用與合約擬訂、簽約與管理 3. 協助試驗相關廠商費用與合約洽談、簽訂與管理 4. 協助合約付款追蹤與管理 5. 協助臨床試驗法規審查資料準備與送件 6. 其它交辦事項

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

1. 執行臨床試驗相關業務，包含試驗前準備、臨床收案、受試者追蹤，及試驗資料管理等； 2. 協助研究倫理委員會送審、管理臨床研究資料； 3. 協助計畫相關行政作業，例如計畫審查作業等； 4. 其他研究主持人交代事宜。

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。

AIBEDA is a Contract Research Organisation (CRO) specialising in medtech and AI-powered healthtech innovation. The company provides end-to-end services, including regulatory strategy, clinical protocol design, technology assessment, and market entry support, to help clients navigate the global regulatory landscape. With a focus on agility, data-driven insights, and global connectivity, AIBEDA transforms complex regulatory challenges into commercial success. Are you passionate about clinical research? Are you excited about medtech breakthroughs impacting people’s health? If the answers are yes, we want to hear from you.

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。

Job Overview: Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions: • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. • Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability. • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase. • Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. • Collaborate and liaise with study team members for project execution support as appropriate. • If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. • If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

臨床試驗案件執行管理等相關工作 1.規劃及執行臨床試驗專案計畫. 2.協調參與試驗團隊，管控計畫進度並確保符合GCP試驗標準程序. 3.監督試驗過程與進度，並追蹤審查試驗成效. 4.專案障礙排除與危機管理. 5.合同項目執行規劃與驗收. 6.客戶關係維護. 7.監督試驗文件品質. 8.支援公司業務推廣工作.

• 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.

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。

【Heroic Faith｜臨床應用專員招募中！】 Heroic-Faith是熱衷於 AI 創新的年輕團隊，致力運用AI技術改善臨床醫療服務品質 【我們在找】 喜歡與人溝通 有熱情與醫護人員溝通及協作 具備良好的教學能力，有現場操作/教育訓練經驗加分 對創新的醫療科技有興趣 渴望參與創新產品的推廣 【工作內容】 1.協助業務團隊向醫院/診所進行產品使用示範與產品功能講解 2.臨床教育訓練、臨床現場支援(含手術室內產品之臨床協助) 3.收集臨床使用回饋，協助產品優化及使用體驗 4.協助推動自費碼並維護與醫師、護理師的良好合作關係 5.以【所在地區】醫院為主及跨區支援 【你將獲得】 跨部門協作經驗，了解從研發到實際應用的完整流程 工作自主且更有影響力，在這裡，您不只是支援產品，而是讓您的專業更加發光!

【職務說明】 1、線上減重諮詢服務及膳食建議 2、提供營養保健食品知識諮詢及產品建議 3、同理心提問與服務，並具有良好溝通能力 4、拍攝短影片 5、其他主管交辦事項 6、公司提供完善培訓制度，師徒制培訓(資深同事會從旁協助)，加速上手時間！ 【條件要求】 1、具有『國考合格營養師執照』 2、持續保持成長心態，勇於面對挑戰 3、喜歡熱忱為客戶解說 【公司福利】 1.一年3次績效獎金 2.端午節禮金 3.中秋節禮盒+禮金 4.生日禮金 5.婚喪喜慶補助 6.兩個月一次慶生會 7.五星級國內外旅遊 8.零食櫃 9員工進修補助 10.年終五星級飯店尾牙+摸彩 13資深員工禮金 14.兩個月一次部門聚餐 15.兩年一次高檔員工健檢

(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. Develop and review the case report form (CRF). 2. Develop and review the database specification. 3. Develop and review the database structure on the database builder. 4. Develop and review the data validation specification. 5. Conduct the database validations including the user acceptance testing. 6. Develop and maintain the CRF library. 7. Develop and maintain the edit checks (ECS) library. 8. Develop and conduct the data review process and dummy data generation. 9. Oversee and coordinate clinical data integration activities as a DMPM. 10. Develop and update the templates of related processes. 11. Develop and manage the working process and standard operating procedures (SOPs). 12. Act as a mentor for the Associate Clinical Data Scientist I 13. Complete other tasks or assignments requested by the Supervisor.