「【Global CRO Company】Clinical Data Manager」的相似工作

具有以下經驗: 實質2年以上試驗案監測經驗 對於計畫書有深度的理解能力 蒐集資料並且適當解決 良好的溝通特質 精準的時間管理

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.

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

Introduction to the job Do you like challenges and do you want to work in a fast pacing supply chain environment to support some of the biggest semiconductor companies worldwide? Are you familiar with Logistics Operations and like to managing urgent demands on a daily basis?  If this sounds like you and if you have a strong customer oriented mindset, here is your mission. Role and responsibilities For our Global Operations Center in Taiwan we are searching for Supply Chain Professionals. You fulfill the demand of our customers for spare parts and tools for their maintenance activities on some of the most complex machines in the right quantity and at the right time & cost. Time is of the essence to ensure a seamless production of our customers without interruptions on our machines. -Handling of urgent material requests from worldwide customers in a rolling 24/7 shift system with the right customer focus, while meeting all milestones related to communication and execution -Monitoring of worldwide shipments  -Ability to resolve complex issues and drive improvements to further optimize processes -Ability to support escalations and provide communication proposals for review -Constructive and reliable communication with worldwide stakeholders from all departments within ASML -This position requires shift work. Education and Experience Bachelor's Degree in related subject i.e. Supply Chain Management, Information Science, Engineering etc. preferred -Minimum 1 year of relevant experience in an international company, semiconductor industry is preferred -A tactical thinker with strong interpersonal and communication skills -Analytical thinking and ability to organize and prioritize workload Skills Working at the cutting edge of tech, you’ll always have new challenges and new problems to solve – and working together is the only way to do that. You won’t work in a silo. Instead, you’ll be part of a creative, dynamic work environment where you’ll collaborate with supportive colleagues.  There is always space for creative and unique points of view. You’ll have the flexibility and trust to choose how best to tackle tasks and solve problems. To thrive in this job, you’ll need the following skills: -Stress-resistant; act under high pressure -Flexible; willing to go the extra mile for the customer -Excellent professional communication in English, written and oral -Drive for results; does not stop until solution has been found, even when obstacles arise -Team player -Change management competencies -Convincing, pro-active and “can do” mentality -Cultural awareness -Experience with ERP system(s), SAP R/3 knowledge preferred -Ability to prioritize 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.

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. 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.

- Responsible for all aspects of site management and monitoring of clinical trials - Manage interactions with all partners (investigators, site teams, internal company departments, external contractors, etc.) to facilitate successful conduct of clinical projects. - Support clinical research activities as assigned by the supervisor. - Build strong professional relationships with investigators, site staffs and internal/ external service providers. - Conduct initiation visits, monitoring visits and site closure visits in collaboration with the clinical project team. - Maintain the Trial Master File. - Prepare and negotiate site clinical trial agreements and manage clinical site budget and expenses. - Preparation of regulatory and ethics submission dossiers. - Ensure protocol-related safety reporting compliance and address and drive issue resolution. - Monitor site recruitment and establish/discuss action plans in close collaboration with the Clinical Project Manager. - Develop and conduct training for investigators and site staffs in the protocol, product and study-specific procedures. - Coordinate activities to ensure compliance with protocol, GCP, overall clinical objectives as well as company policies and SOP. - Manage trial product inventory, shipment and storage, and ensure accountability and traceability. - Ensure that imaging and/ or laboratory samples are collected, handled and shipped according to protocol requirements. - Ensure that safety reporting of adverse events is completed within required time periods. - Manage external vendor services for assigned clinical sites. - Identify issues which affect clinical trial progress and quality, and develop solutions and/ or take action to resolve/ prevent them. - Deliver projects according to expected targets, budgets and quality standards. - Monitor and report to clinical management teams on clinical trial progress, performance and plan, including subject recruitment and retention, monitoring activities, data completeness and quality, and site compliance. - Assist in the organization and conduct of internal and external stakeholder meetings, as required. - Set up, maintain and update clinical research activities and initiatives in the system.

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。

• 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.

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.

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. 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. Assist the clinical team in the preparation and distribution of administrative matters and clinical trial materials. 2. Assists the clinical team in filing and archiving clinical documents and reports according to scope of instructions. 3. PK sample logistics management, material ordering and preparation, distribution to sites, and contact with logistics for sample delivery. 4. Complete other tasks or assignments requested by Supervisor.

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.

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. Assist in performing project proposal tasks including drafting budget quotations. 2. Perform administrative management processes, including business document/ file archiving and management, payment processing, and project closure. 3.Meeting coordination and arrangements, assist in project database integration and update project-related master lists. 4. Assist in participating in biotech/medical-related exhibitions and marketing activities, collect and compile client information and conduct periodic client visits. 5. Provide business projects support and perform other tasks assigned by Supervisors. 6. SOP revised and updated by BD director's instruction.

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。

***履歷請直接投遞至以下Adecco官網連結 : https://foapac.my.salesforce-sites.com/jobboard/JobRegisterForm?JobId=a1sMn000004vkztIAA *** 職位簡介： -此為派遣職(無限期) -本職位負責推廣公司藥品產品，拓展新市場與客戶關係，提供專業藥學知識支援，並達成銷售目標。理想人選具備藥學相關背景，溝通能力佳，能獨立進行陌生開發，具備英文能力與業務經驗者佳。 主要職責： -向負責地區診所介紹公司藥物產品 -建立並維護客戶關係，定期拜訪醫師與藥師 -針對新市場進行陌生開發與潛在客戶挖掘 -參與醫藥會議與產品訓練，提供專業解說與支援 -收集市場資訊與競品動態，提供策略建議 -與內部團隊合作，達成銷售目標與推廣計畫 任職資格： -藥學、生物科技或相關科系背景佳 -良好的口頭與書面溝通能力，能清楚表達專業資訊 -具英文能力 -有藥品或醫療相關產品推廣經驗尤佳 -勇於挑戰、具開發新客戶能力與積極業務心態 福利: -業績獎金 -休假: 優於勞基法年假與要派公司內部額外公司假 -病假:3天全薪病假 -團保 -三節及開工紅包，生日禮金 -健康福利: 體檢及疫苗補助 -業務需求: 話費，車貼(車齡10年以下)，車費，交際費等等補貼 -年終獎金 ***歡迎應屆本科系學生投遞*** Job Purpose and Key Responsibilities： Job Purpose To identify the business opportunities in your territory(i.e. area hospitals and general practice) and to promote portfolio through scientific selling Key Responsibilities • Develop strong understanding of the relevant diseases and competitors' medicines(e.g. science and benefits) and effectively apply scientific knowledge in a patient-focus selling • Able to use multiple data sources to analyze and review territory performance dynamics(including competitor performance) identifying territory trends and opportunities for the company • Builds territory insights that capture opportunities and drive decision making, including the selection and prioritization of customer targets and the development of robust territory coverage call plans • Develop, based on customer insights, multi-channel business plans with strategically aligned ASMART objectives, strategies and tactical activities that deliver business objectives • Implements multi-channel business plans aligned to customers’ preferences, uses KPIs to track performance and adjust plans where required • Develop strong collaborative relationships with internal and external stakeholders to enable successful execution of operational plans/objectives • With the support of line manager, ensure successful formulary listing of the medicines in your territory In all areas, demonstrate understanding of and compliance with laws, codes of conduct, policies and frameworks in which the company operates and live our vision, values and expectations

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

醫藥/醫療器材/化妝品領域都是我們正在找尋的人才喔 ~ 1.負責彙總、解讀藥物註冊法規、技術要求(包含但不限於TFDA、FDA法規、ICH指南)，並為公司研發提供合規指導和風險管理； 2.準備原始IND、修改和補充，包括與其他部門對接以獲得必要的組件和草稿報告和敘述組件 3.了解藥品的生命週期和基本的GMP工作流程 4.積極參與監管報送流程及參與產品開發週期的風險評估 5.跟進公司在研專案分配與協調，跟進註冊專案進度，及時發現和處理註冊專案進程中的問題，確保完成註冊任務; 6.協調和處理註冊評審過程中的相關問題； 7.及時掌握藥品註冊政策的變化情況，對研發人員進行培訓和管理。 1. To prepare timely original IND, amendments, and supplements, including interfacing with other departments to obtain the necessary components and drafts reports and narrative components 2. Understanding of the lifecycle of drug products and basic GMP workflow 3. Actively involved in the regulatory submission process 4. Involve in the risk assessment during product development cycle