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.

Advanced SAS programming knowledge above 2 year of working experience in Pharmaceutical industry BSc or higher degree in Mathematical, Statistical, Computer Science or Life Science or equivalent experience Technical / Skills Training Proficient knowledge of CDSIC standard and industry best practices In-depth Knowledge of database setup and report publishing requirements In-depth Knowledge of technical and regulatory requirements related to the role Knowledge of statistical concept Knowledge of the drug indications within a therapeutic area, eg. Oncology Experience in building and maintaining effective working relationships within teams Ability to lead project independently with strategical thinking and work on multiple tasks Ability to prioritize and project manage to optimize support. Excellent verbal and written communication skills Other programming languages are preferred e.g. R, S-PLUS, Python, XML etc 歡迎持有身心障礙證明者投遞

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！

o Negotiation and Execution of Clinical Trial Agreements (CTA): § Prepare, and review Study Site level budgets and contract templates and facilitate finalization and approval with the Sponsor, Legal, and any applicable internal personnel. § Proficiently negotiate CTAs, budgets and ancillary agreements. § Proficiently oversee all contractual documents and correspondence, including the facilitation of the indemnification process between Sponsor and Study Site. § Establish and maintain effective and proactive communication with Study Sites, Sponsors and internal personnel regarding the status of budgets, contracts and any other contract-related documents. § Ensure CTAs, budgets and ancillary agreements are negotiated within the Study specific agreed parameters and if not, appropriate approvals are obtained and documented. § As required, proficiently prepare, review and negotiate amendments to CTAs, budgets and ancillary agreements. § Conduct second level quality control review of completed CTAs, budgets and ancillary agreements prior to execution. § Serve as the internal liaison on study site budgets with respect to country needs and requirements. § Forecast Budget and Clinical Trial Agreements execution timelines and ensures they are achieved; provide risk assessment and contingency plans to mitigate impact if forecasted timelines are not reached, and escalate issues as soon as identified. § Prepare, review and negotiate Master Service Agreements with sites. o Competent Authority (CA), Ethics Committee (EC) and Institutional Review Board (IRB) Submissions: § 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. § Effective interaction with Ethics Committees, Institutional Review Boards and Country Regulatory Agencies (Competent Authorities) to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct (start up and maintenance as assigned). § Forecast submission/approval timelines and ensure they are achieved; provide risk and contingency plans to mitigate impact if forecasted timelines are at risk, and escalate issues as soon as identified. *歡迎持有身心障礙證明者申請*

Working fully embedded within the local clinical team at our client’s offices, The Site Activation Partner is responsible for supporting operational activities related to site evaluation, activation, initiation, monitoring and close out for assigned investigator sites/studies to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and company standards. The Site Activation Partner will provide technical and logistical support to the Site Relationship Partners to deliver Investigator Initiation and Study Start Up. The tasks undertaken by a Site Activation Partner are varied and can include: • Clinical Trial Site Activation & Conduct o Assist with study site activation activities to ensure timely site activation. o Register investigator sites in company registries as required. o Support and/or coordinate central Investigator Review Board (IRB) submissions when needed. o Work with investigator sites to complete critical information for site activation; inclusive of, but not limited to, Investigator Initiation Packages (IIP), confidentiality agreements, study contracts, clinical supply shipment information, payment information, IRB submission and status. • Communication o Act as a point contact for the GSSO team members for designated project site communications, correspondence and associated documentation. o Maintain ongoing contact and communication with the GSSO team members as needed. • Clinical Trial Monitoring Support o As needed, support the Site Relationship Partner with coaching and training of site personnel to ensure ongoing compliance with study documentation is in accordance with prevailing laws, Good Clinical Practices, and Client standards. o In collaboration with the Site Relationship Partner, conduct or oversee investigator site activation activities, IIP completion, site budget and contract negotiation, and ensure timely management of emerging issues that may compromise time to site activation. o In collaboration with Site Care Partner and Outsourcing Lead, facilitate site payments as needed and as per contracts and work with the appropriate groups to resolve issues. You are: o 2 years relevant experience in clinical research field o Must have initial submission experience o Experience in study activation and site management is an asset o Knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations o English fluency is necessary for reporting to a foreign manager. o Detail-orientated, passionate and reliable. *歡迎持身心障礙證明者投遞*

Overview -Clinical Operation: Support CTM on system maintenance, contract & payment process, IM & SIV coordination and support -Department Task: Department meeting coordination, study meeting coordination, vendor and PO invoice process -Skillset: Good communication/ coordination skill, English ability (writing, reading) Key responsibilities 1) Set up and maintain applicable TMF (both electronic and hard copy versions). Alert management where current status of data quality or performance is at risk to noncompliance. 2) Maintain, update, and input information and/or documents into applicable databases for clinical trial and/or data tracking; ensure reporting system records and quality standards are appropriately maintained. 3) Track incoming and outgoing clinical and regulatory documents/updates for investigator sites, studies, or project team 4) Support assigned group(s) or team(s) in preparing applicable study documents. 5) Manage central inbox and process site requests to appropriate team members and serve as the primary point of contact for field monitoring staff and global DRA. 6) Order supplies to support all phases of clinical studies and maintain import/export license requirement. 7) Distribute safety notifications and coordinate the ordering, labelling, release, distribution, relabelling and destruction of IMP; manage the documents and shipments from local depot and ensure proper blinding during the study period. 8) Act as system administrator and provide support for Horizon timesheet, Up4Growth and other system modalities, as assigned. 9) Follow standard operating procedures 10) Operates largely in transactional activities with oversight