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！

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 • 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

As a Site Contract Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Working model: Home Based What you will be doing: #Prepare, negotiate, and finalize clinical trial agreements and ancillary agreements for company sponsored and/or investigator-initiated studies through direct negotiation with clinical trial sites or via oversite of a Clinical Research Organization responsible for contract negotiations. Responsible for delivery on established targets/measurements. #Work with global teams to review and analyze contractual terms and conditions. Assess legal and budget risks in conjunction with team support functions. Partner with Healthcare Compliance, Risk Management, Privacy and other stakeholders to obtain guidance and drive resolution. Escalate as appropriate. #Analyze investigator fees in relation to fair market value pricing and ensure alignment with regional standards and pricing guidelines. Participate in and/or lead approval escalations as appropriate. #Provide support for negotiations in confidentiality agreements, informed consent forms and other ancillary contract documents as required. #Participate in discussions related to the development of site/investigator budgets aligned with fair market value. #Manage the contract amendment lifecycle. #Work with the global team as necessary to review and analyze contractual terms to reach resolution. Assess risks of budget and legal provisions in conjunction with members of thee team and support functions. Escalate issues as appropriate. #Work proactively to provide recommendations to improve processes and establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trial sites. #Assume responsibility for all aspects of legal document and metrics tracking. Provide support to review, authorize and/or understand aspects of site payments. #Assist clinical operations or clinical team in ensuring that investigator grants comply with overall study costs and compliance guidelines. #Track all aspects of legal document and metrics. Determine potential needs for contract amendments and manage amendment lifecycle. #Work proactively to improve processes and establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trial sites. #Ensures Inspection readiness by maintaining complete, accurate and timely data and essential documents in systems utilized for trial management according to expectations and archiving retention requirements. #Ensure inspection ready and comply with relevant training requirements and developing therapeutic #knowledge to ensure service delivery. *歡迎持有身心障礙證明者申請*