「Clinical Trial Oversight Manager」的相似工作

本職缺只接受國泰人壽徵才網站的履歷表，請立即至以下網址登錄您的資料：『https://pse.is/4c38kp』 【114年國泰人壽營運企劃聯合招募】 如果您具備以下能力又對於營運企劃充滿熱情，那國泰找的就是您們! 1. 思考邏輯清晰，具問題分析解決、跨團隊協作能力 2. 主動積極的學習態度，具獨立作業、研究及執行能力 3. 具備良好溝通協調、簡報技巧能力 4. 熟悉MS Office，會運用SAS或其他統計軟體佳 聯合招募分為三大職系-通路企劃、營運企劃、核保理賠 通路企劃部門 : 業務部、保險代理部、直效行銷部 營運企劃部門 : 綜合企劃部、據點服務發展部、客戶關係促進部、智能客服中心 核保理賠部門 : 理賠部、保費部、審查部、保單行政部 詳細職缺內容請點選以下連結查看:https://cathaylife.surveycake.biz/s/r1GgB

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. 獨立作業而且能掌握研發專案的時程及成果交付。 2. 具管理內部資源之能力，控制部門/或專案活動之預算。 3. 臨床試驗文件撰寫和/或審閱。 4. 評估專案相關議題並研擬解決方案，與專案主管、團隊及外部合作者、委外供應者進行協調溝通。 5. 委外研究、CRO之評估、執行追蹤及品質管理。 6. 各國IND申請及臨床驗證之規劃及執行。 7. 具供應商管理經驗。 8. 具有CRA經驗尤佳。

【Position Summary】 Formosa Pharmaceuticals is a biopharmaceutical company operating in the areas of ophthalmology and oncology, with emerging interests in respiratory, dermatology, and age-related ailments. We are seeking a Clinical Research professional to join our team. The successful candidate will review, analyze, and design clinical protocols, monitor clinical trials, and communicate with CROs, external stakeholders, and international regulatory agencies. To learn more about our company, please visit: https://www.formosapharma.com 【Job Responsibility】 • Prepare and critically review and revise clinical trial protocols • Clinical trial operations oversight and direction through direct communication with clinical trial CROs, vendors and authorities • Identify and communicate with local and international KOLs in therapeutic indications related to corporate programs • Identify and engage with consultants and CROs for services related to company programs • Analyze and review clinical trial data to support scientific and business decisions • Generate and deliver presentations on behalf of Formosa Pharmaceuticals 【Technical requirements】 • Establish comprehensive understanding of company strategy and programs and keep current with latest relevant research and development • Generation and review of technical reports and presentations • Ability to search and survey technical literature using online tools 【Minimum Qualifications】 • Advanced degree in clinical sciences, or equivalent combination of education and experience. M.D. or Ph.D. is a plus • Experience with oncology clinical trials and managing clinical CROs • Strong understanding of clinical trial methodology, regulatory affairs, and medical strategy • Effective bilingual (spoken/written) communication in English & Chinese 【Required application material】 • Curriculum vitae (CV) • Summary of experience with detailed emphasis on clinical trial work • References with contact information

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. 負責該責任區域各醫院之跨科別不同病患計畫(專案)執行。 2. 病患衛教或/及健保事審協助事宜。 3. 須配合班表出勤駐診或依據患者約診時間提供實地與電話訪視服務。 4. 及時透過電子郵件與電話服務，提供即時的病患支持服務。 5. 負責病患/客戶個人化的照護。 6. 協助確保供的服務符合專案要求的服務標準與規範、法規及公司行為準則。包含但不限於病患在專案的持續期間、病患個資保密等。 7. 專案藥物不良事件通報。 8. 工作地點目前為：雙和、萬芳及台北長庚，必要時依照專案進行地點調整。 9. 需具有護理師執照。

 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. 熟悉國外法規機關(主要為US FDA)之藥證申請流程與相關法規 2. 以英文撰寫國外查驗登記CTD文件 3. 需有成功取得國外(US or EMA)針劑藥證之經驗 4. 維護國外之上市後藥證 5. 有關國外藥證之事務溝通、協調、提供意見與資料

*此為Adecco外包職缺，合約期間一年** *歡迎將履歷郵寄至Maggie.huang@adecco.com 【Job Purpose】 PSP manager is responsible for optimizing PSP vendor profile for potential new coming solutions, and improve program’s impact and efficiency, aligning with companys vision and patient-focused approach, as well as global and local related policy. Support driving PSP excellence. 【Major Accountabilities】 As SQA Manager and ESP management (strategic ESP contract and ESP optimization)  Responsible for the overall management of the External Service Providers (ESPs), being the main point of contact and ensuring the following activities are completed prior to the beginning of ESP services: - Conduct of POP Supplier Quality Assessment (SQA) and other supplier qualifications, including Information Security and Risk Management (ISRM), External Partner Risk Management Assessment (EPRM), Anti-Bribery, etc. - Contract management and execution, including Pharmacovigilance and data privacy language - Ensure ESP AE training completion  Collaborate with different stakeholders to onboard, manager ESPs and support assess the performance and compliance of ESP, and provide the recommendations for subsequent actions  Ensure compliance with all applicable local laws and regulations  Provide support during internal and external audits and inspections as required

This role is for upcoming future opportunities that may arise at Fortrea. Fortrea is excited to connect with talented individuals for future opportunities. If you meet the job requirements, we'll invite you for an interview. If you're pre-selected, our recruiter will keep in touch and let you know when the role officially opens, so we can reconfirm your interest before moving forward with an offer. Job Overview: Site monitoring and site management responsibility for clinical studies according to Company, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. Assures the implementation of project plans, as assigned. Summary of Responsibilities: Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned. Responsible for all aspects of site management as prescribed in the project plans. General On-Site Monitoring Responsibilities. Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study. Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements. Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausible data. Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy. Ensure audit readiness at the site level. Travel, including air travel, may be required and is an essential function of the job. Prepare accurate and timely trip reports. Interact with internal work groups to evaluate needs, resources, and timelines. Act as contact for clinical trial supplies and other suppliers (vendors) as assigned. Responsible for all aspects of registry management as prescribed in the project plans. Undertake feasibility work when requested. Participate in and follow-up on Quality Control Visits (QC) when requested. Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned 18) Assist Senior CRA with managing investigator site budgets. Track and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs. Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management. Assist with training, mentoring and development of new employees, e.g., co-monitoring. Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned. Perform other duties as assigned by management. Qualifications (Minimum Required): University or college degree in a related allied health profession from an appropriately accredited institution. Basic knowledge of Regulatory Guidelines. Basic understanding of the clinical trial process. Fluent in local office language and in English, both written and verbal. Experience (Minimum Required): 2 years CRA experience with on-site monitoring experience. Oncology trial experience is MUST. Basic understanding of Regulatory Guidelines. Ability to work within a project team. Good planning, organization, and problem-solving skills. Good computer skills with good working knowledge of a range of computer packages. Works efficiently and effectively in a matrix environment.

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

Working location: ICON office, fully office based. **No flexible to work from home. What you will be doing: • TMF filing, quality, maintenance, compliance, and oversight • Development and delivery of sites’ ISF, and eISF when utilized, and act as primary point of contact for the sites and manage the Site Operations/monitor access to eISF prior to SIV • Maintain sponsor Registries and systems as required • Provide reporting to support management of clinical trials • Provide support with audit and inspection readiness activities • Perform customization and translation of documents as required • Preparation of documents and communications for distribution to and collection from sites, as required • Manage physical printing, shipping and archiving needs as required • Contribute team project and initiative at country or regional level • Provide technical and operational support to the study team members from study start up to study close out • Support of site payment services, patient compensation services and other local payments as required • Works proactively and independently to coordinate and prioritize multiple key tasks at site, country and study level. • Serve as SME for key CTA processes, systems and tasks. • Collaborates with regional or local cross functional study team members of varying levels of seniority. • Use established procedures and methodologies to ensure the completion of assigned tasks according to timelines and to required quality standards. • Perform the assignments by supervisors • Be agile and flexible in adapting to the changes in work scope according to business needs <For Senior level> • Provide support to managers for development and implementation of on-board training for new hires • Work with managers to identify continuous improvement opportunities to enhance operational efficiencies. • Gathers and retains knowledge of local processes that enable clinical trial execution where required. • Lead the development and delivery of sites’ ISF, and eISF when utilized, and act as primary point of contact for the sites and manage the Site Operations/monitor access to eISF prior to SIV

We are seeking a drug development professional to join TaiMed's Clinical Development & Regulatory Affairs team. Play a key role in advancing innovative therapies through clinical development and regulatory pathways. - Coordinate global regulatory submissions (IND, BLA, and other CTD dossiers). - Support GMP-related change controls to ensure regulatory compliance. - Ensure efficient project execution with CROs. - Coordinating communication among internal teams and external partners, many of whom are international. **Strong English communication skills REQUIRED ** - Study scientific literature, clinical guidelines, and global regulatory requirements for drug development. - Title depends on experience.

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.

【職務內容】 1.協助臨床試驗啟動流程，包括準備並遞交相關審查資料（如 IRB、TFDA 等） 2.執行研究機構啟動相關作業，協調合約、預算、受試者同意書等文件的準備與簽署 3.與研究機構保持溝通協調，協助解決試驗過程中行政與文件問題 4.進行試驗文件與資料管理，確保符合法規與公司 SOP 5.協助追蹤研究進度，支援試驗過程中的行政事務 6.協助報支臨床研究相關費用、付款流程與系統建檔 7.配合內部跨部門溝通，確保專案時程與品質要求 *公司辦公室資訊: 110 台北市信義區松高路 *此工作為Adecco派遣至客戶端 *此職位為長期派遣需求，歡迎期待穩定工作的您!

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.產業導向的嗅覺科學(Olfactory Science) 相關產品研發及企劃工作。 2.嗅覺科學(Olfactory Science)與 Endocrine System, Immune System及Central Nervous System 等相關研究。 。 3. 產品相關資訊調查及收集。 4. 期刊論文撰寫。

Are you motivated by driving innovation for the life-changing benefit of patients? Are you ready to help transform the treatment paradigm for a broad range of chronic diseases that currently rely on injection-based therapies? Then this is your moment. Apply now and join Novo Nordisk. Together we can create life-changing innovation. Together we can make it happen. The position Communicaitons Strategy & Planning • Develop and execute integrated communication strategies that advance patient well-being and public health goals while supporting the company’s corporate and business priorities across key therapeutic areas. • Build and manage an annual editorial calendar to ensure consistent, timely, and impactful messaging across channels.• Localize and adapt global/regional campaigns to fit Taiwan’s market dynamics and stakeholder needs. Social Media & Digital Engagement • Lead the development and execution of social media strategies that amplify disease awareness, product value, and corporate reputation. • Plan and manage digital content and community engagement across platforms.• Oversee the creation of high-quality, channel-specific content (e.g. articles, videos, patient stories, infographics) in collaboration with internal teams and external agencies, ensuring message consistency and brand alignment. • Monitor social media trends, public sentiment, and competitor activities to inform real-time responses and strategic adjustments. • Leverage insights and analytics to drive continuous improvement in reach, engagement, and impact. Media, Public & Stakeholder Engagement • Manage and nurture relationships with media, KOLs, KOIs, patient groups, medical associations, and communication agencies. • Plan and support media events, interviews, press briefings, and disease awareness campaigns to strengthen brand voice and visibility.• Deliver strategic messaging and communication materials to support stakeholder engagement, including healthcare professionals, payers, and advocacy partners. Campaign Execution & Cross-Functional Collaboration • Lead communication efforts for product launches, disease awareness days, and corporate campaigns. • Partner closely with Marketing, Market Access, Medical Affairs, Sales, and Patient Support teams to ensure consistent message alignment and high-quality execution. Issues & Risk Management • Monitor the external environment—including media coverage, social sentiment, policy changes, and competitive activity—to anticipate risks and opportunities. • Provide strategic counsel and lead aligned communication responses during issues or crises to protect and reinforce Working at Novo Nordisk At Novo Nordisk we recognise that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and the communities we operate in. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We are happy to discuss flexible working, depending on the role and subject to business needs.

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。

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。

ICON公司為全球前五大CRO 臨床試驗機構，全球第一大FSP公司，與全球頂尖的藥廠合作，提供專業的臨床研究服務。 提供員工良好且完整的教育訓練，透明的升遷制度，完善的休假制度，周休二日，讓員工能在良好的支援下為世界提供更新、更好的新藥品。 臨床試驗專員 1.藥品臨床試驗計畫啟動至結案過程的觀測及監督。 須具備良好的溝通能力以及敏捷的緊急應變能力，能跟試驗單位進行良好的溝通，並協助案件進行。 2.臨床試驗相關個案報告整理。須具備良好的檔案管理能力。 3.工作型態：需要出差到試驗單位(醫院)，查看臨床試驗的進度，並定期回報給專案經理，確認試驗持續符合計畫案的里程碑。出差天數依據試驗案的進程而定。 4.具備良好的英文讀寫能力，所有公司文件皆以英文撰寫。 5.目前需要具備一年以上的臨床試驗案進行經驗的人才。職級及薪水的核定將以面試來決定。面試有兩關，約在兩周內就會完成。 6. 歡迎持有身心障礙證件者投遞 Responsibilities The Clinical Research Associate is ultimately responsible for the successful management of investigator sites throughout the trial lifecycle. Key responsibilities include: 1. Full ownership of investigator sites for assigned studies with responsibility for the successful management of the site right through to close-out. 2. Planning and conducting various site visits (feasibility, site selection, interim and close-out) in accordance with the clinical monitoring plan. 3. Develop effective relationships with investigator site staff to ensure that key clinical metrics are met. 4. Preparing for and attending investigator meetings, coordinating the timely shipment and the subsequent proper storage and accountability of clinical supplies, and following up on drug safety issues. 5. Ensuring the integrity of clinical data through an ability to sufficiently maintain site tracking records and work diligently to relevant guidelines 6. Negotiation and ongoing management of clinical trial agreements with investigative sites.