ICON_台灣愛康恩研究有限公司

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.

Responsibilities: ICON global programming team is steadily expanding and due to recent promotions we are looking to hire (Senior) Statistical Programmers and provide service to single sponsor. The global programming management team are consistently focused on identifying and retaining industry leading talent. Using a supportive and engaged management style they will provide a focus for staff development alongside an effective work/life balance. The successful candidate will assist with the delivery of projects as Statistical Programmer (ADaM and TFL focused). Key responsibilities in this role include: 1. Demonstrate 4yr+ SAS programming expertise through the development/QC of ADaM/Analysis Datasets and TFLs. 2. Depending upon experience, demonstrate leadership skills in the coordination of analysis and reporting activities for statistical programming projects. 3. Depending upon experience, provide input to and/or develop clinical trial reporting documentation to support the analysis and reporting activities for statistical programming projects. 4. Contribute to departmental initiatives which identify process or tool developments to continuously increase project quality and/or efficiency. Qualifications * Degree qualified and demonstrable experience working within a CRO and or pharmaceutical industry (Master and above) * Expertise in SAS and solid CDISC knowledge * Strong project leadership skills and have excellent communication skills *歡迎持有身心障礙證明的人才進行投遞！

As a Site Selection Specialist in ICON, you need to : To identify, contact and build relationships with study investigators/ sites and networks in assigned areas (e.g. region(s), countries / countries or therapeutic area) for the conduct of feasibility and potential study participation and become an expert on the conduct of studies in the designated areas. To develop, and share with others in support of the conduct of feasibility and Site Identification, details on the healthcare setting, standard of care, investigators, optimal recruitment strategy within the designed Area of Responsibility To build knowledge in ICON’s investigator database and feasibility management system (e.g. investigator profiles, country demographics) and increase the access of knowledge stored in these databases. To ensure data gathered is accurate and of a high quality, in order to make the best decisions in terms of site Identification Benefits of Working in ICON: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent. *歡迎持有身心障礙證明者申請*

We are currently seeking a Site Activation Lead to join our diverse and dynamic team. As a Site Activation Lead at ICON, you will advance clinical trial start-up activities by understanding client objectives and assisting in the development of the plan for country and site distribution. We pride ourselves on our amazing company culture, where we work as one team to achieve industry-leading results. What you will be doing Lead clinical trial start-up activities, understanding client objectives and assisting in the development of plans for country and site distribution. Oversee day-to-day delivery of all aspects of site activation in assigned projects, ensuring adherence to sponsor timelines, expectations, and compliance with ICON/client KPIs, SOPs, and regulatory standards. Ensure that each project has a comprehensive site activation plan, conducting studies effectively in accordance with the plan. Lead sponsor initiatives such as kick-off meetings, bid defenses, project updates, status calls, and other key communications. Utilize project management skills to optimize performance and collaboration, ensuring successful study outcomes. Your profile Bachelor’s Degree, preferably in life sciences. Minimum of 5 years of experience in a Clinical Research environment, focusing on Start-Up experience. Strong project management skills, with a deep understanding of regulatory and submission processes in various countries. Excellent written and verbal communication abilities. Proven ability to work efficiently to tight deadlines and manage multiple priorities. **歡迎持有身心障礙證明者投遞**

As a Study Support Assistant (SSA), you will play a key role in independently assisting the team to ensure the most effective and efficient study start up, by providing administrative and tracking support. The Role • Supporting the Study Start up Associate with tasks including; tracking, filling, collating and verifying, for completeness, submission documentation for submission to the Regulatory/Competent Authority (CA)/Ethics Committee(EC) and other relevant authorities and helping with the translation of these documents • Looking after the submission progress tracking by updating the relevant ICON/Sponsor tracking system. • Be proficient with ICON/Sponsor Clinical Trial Management System (CTMS). • Setting, up, coordinate and maintain department electronic filing systems. • Coordinate and attend meetings as requested and assist in the production of slides, overheads etc as needed • Assisting in the co-ordination of payments to CA/EC and other relevant authorities and be familiar with ICH GCP and ICON SOPs What you need • The successful candidate will have a high school diploma, or local equivalent with good interpersonal skills and the ability to handle multiple tasks with meticulous attention to detail • Research or Healthcare related academic or work experience would be preferable but not essential • You will possess excellent written and verbal communication in English

Senior Site Specialist (Senior Study Start Up Associate)- Taiwan - Office Hybrid) ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development Recognize, exemplify and adhere to ICON’s values of Accountability and Delivery, Collaboration, Partnership and Integrity, which center around our commitment to Ownership. Proficient knowledge of ICON SOPs/WPs, ICH/GCP and applicable country regulations/guidelines and ICON systems. Work with Site Partners and internal key stakeholders to optimize study performance and collaborate to dirve successful site activation and project outcomes. Support the set up of internal tracking tools needed for site activation to enable effective tracking of progress according to site activation requirements. Serves as internal consultant to optimize site activation work and tool set up Act as primary point of contact on high volume studies or on study programs to coordinate the activities of Site Activation Specialists and to support execution of Site Activation to plan. Support training and onboarding of more junior Site activation specialists, if assigned on the same studies. Proficiently drive Site activation duties per assigned studies and sites and that include: • To support Site Partners to proficiently collect, review, organize and assemble regulatory initial start-up and maintenance submission packages to Central EC/IRB, Local EC/IRB, Competent Authorities, any other local regulatory authorities as required by countries and in accordance with ICH/GCP and applicable country regulations/guidelines. • To support collection and assembling of all documents needed in the Critical Document Package (CDP) and of those required for site activation, ensuring that Sponsor and Investigator obligations are being met and are in compliance with applicable requirements and ICH/GCP guidelines. • To ensure accuracy and completeness of the Critical Document Package according to CDP checklists and timely update of the required tracking tools. • To support coordination of all necessary translations required for any start-up documentation. • To proficiently perform timely and accurate progress data entry of all documents collected from sites and relevant study site activation activities into the appropriate tracking systems and tools and oversee that the site activation tasks are executed according to site activation requirements. • Ensure accuracy and timely completeness of Trial Master File (TMF) documents submitted during start-up and perform a Quality Control (QC) review of files before transfer to maintenance for filing in TMF. Accurately forecast Site Activation plans and ensure they are reflected accurately in ICON’s systems, proactively follow through for achievement to plan. Contribute to effective site activation process and timelines: participate to internal study review meetings with study teams and support risk identification to site activation, mitigation and action planning. Other duties as assigned