美商IQVIA_艾昆緯股份有限公司

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward. - Assist Clinical Research Specialist (CRS)/In-house Clinical Research Specialist(iCRS), Clinical Research Associates (CRAs)/In-house Clinical Research Associate(iCRA) and Regulatory and Start-Up (RSU) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines. - Assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Assist with periodic review of study files for completeness. - Assist CRS/iCRS, CRAs/iCRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information. - Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow. - Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation. - May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training and with required approval. - May perform assigned administrative tasks to support team members with clinical trial execution.

Job Profile Summary: Under general supervision, perform tasks at a country level associated with site activation activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. Essential Functions •Under general supervision, perform site activation activities in assigned studies for investigative sites, according to applicable regulations, SOPs and work instructions, working closely with the Site Activation Manager (SAM), Project Management team, and other departments as necessary. Review documents for completeness, consistency and accuracy, under guidance of senior staff. •Prepare site regulatory documents, reviewing for completeness and accuracy. •Inform team members of completion of regulatory and contractual documents for individual sites. •Distribute completed documents to sites and internal project team members. •Support the updating and maintenance of internal systems, databases, tracking tools, timelines and project plans with accurate and complete project specific information. •Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF) and Investigator Pack (IP) release documents.

·Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Management and CST. Ensure adherence to standard operating procedures (SOPs), work instructions (WIs), quality of designated deliverables and to project timelines. • Perform Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members. • Prepare site regulatory documents, reviewing for completeness and accuracy. • Review, prepare and negotiate site contracts and budgets with sites. • Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information. • Review and provide feedback to management on site performance metrics. • Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed. • Inform team members of completion of regulatory and contractual documents for individual sites. • Review, track and follow up the progress, the approval and execution of documents, including contracts, regulatory, ethics ICF and IP Release documents, in line with project timelines. • Provide local expertise to RSU leads and Project team during initial and on-going project timelines planning. • Perform quality control of documents provided by sites. • May have direct contact with sponsors on specific initiatives. • May perform Site Selection Visits if a trained monitor. • May participate in feasibility and/or site identification activities.

【職責】 協助財務部日常作業，包括： 1. 每日付款文件整理 2. 收集並掃描各部門提交之請款文件 3. 發送付款後之通知信件, 像是提供付款證明及支票之領取 4. 檔案管理 5. 其他主管交付的工作 【職位要求】 1. 學術背景：大學畢業，不限科系，商學院優先考慮 2. 工作經驗：工作經驗至少2年，財務會計相關經驗者優先考慮 3. 上班時間：能配合每週4~5天者，其中需包含週二跟三，持續一年; 可接受每天提早1-2小時下班 4. 學習能力強; 工作認真負責; 做事細心; 對數字有較高之敏感度; 有較強的ownership

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward. One of FORTUNE’s ‘Most Admired Companies’, we offer unparalleled scope for a career in world-leading clinical research. Global projects, innovative tools and industry leading customers combine with outstanding support and clear career management which allows you to make a difference and to connect with great opportunities. Main Responsibilities: • Negotiate site contracts from the contract templates using appropriate guidelines, and collect necessary signatures for contract execution. • Negotiate site budgets from base budget and payment milestones using appropriate guidelines; complete final Schedule A for addition to contract. • Escalate contract and budget issues to Legal or Clinical Pricing & Payments Group and GCPM as appropriate to ensure Fair Market Value compliance. • Set up financial data, raise purchase orders and handle appropriate entries/requests into relevant financial and payment systems. Support Clinical Pricing & Payments Group in setting up sites for eGPS or legacy systems. • Track contract progression using appropriate systems. • Amend and terminate contracts as necessary throughout lifecycle of study. • Store and archive contracts and budgets in appropriate systems. • Maintain payment records and provide assistance with audit review records. • Responsible for reviewing and approving, with Law guidance, applicable changes within ICF part 2. • Responsible and/or point-of-contact at vendor level for the contracting process for locally outsourced studies. • Responsible for the Clinical Trials Insurance process. • Participate in appropriate site/legal meetings as required to resolve contract issues. • Participate in appropriate site/finance meetings as required to resolve payment issues. • Maintain party information and contract activation in Contract Generation System. • Approve or reject clinical invoices. • Process and track Confidential Disclosure Agreements as appropriate. • Manage contracting process with Clinical Trial Related Consulting Agreements. • Manage all study-related Site payments not managed by Clinical Pricing & Payments Group.

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward. One of FORTUNE’s ‘Most Admired Companies’, we offer unparalleled scope for a career in world-leading clinical research. Global projects, innovative tools and industry leading customers combine with outstanding support and clear career management which allows you to make a difference and to connect with great opportunities. • Oversee the execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines. Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required. Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan. Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required. Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements. Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team. Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations • identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan. Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required. Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents. Work with Quality Management to ensure appropriate quality standards for the duration of site activation (or Maintenance, as applicable). Mentor and coach colleagues as required. Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information. May take a lead role in developing long standing relationships with preferred IQVIA customers. Deliver presentations/training to clients, colleagues and professional bodies, as required. May be involved in activities related to monthly study budget planning and reviews.

Job Overview Conducts the financial and accounting operations of the organization. Prepares, collects and interprets financial information; prepares budgets, reports, forecasts and statutory returns; conducts financial analyses of proposals, investments and fund sources; manages the organization's taxation affairs; manages cost accounting systems and cash flow; conducts audits; controls treasury and ensures compliance with regulatory standards. Essential Functions - Manages end-to-end investigator payment process including the coordination and facilitation of grants to investigators involved in clinical trials. - Partners with clinical operations teams and IT organization to align electronic data capture feeds with investigator site visit milestones to enable automated payment triggers. - Manages payment process with the accounts payable teams, forecasts of investigator payments and tracks budgeted payments against incurred costs.

【職責】 協助財務部日常作業，包括： 1. 每日付款文件整理 2. 收集並掃描各部門提交之請款文件 3. 發送付款後之通知信件, 像是提供付款證明及支票之領取 4. 檔案管理 5. 其他主管交付的工作 【職位要求】 1. 學術背景：大學或碩士在學生，不限科系，商學院優先考慮 2. 工作經驗：不限，有財務會計相關實習經驗者優先考慮 3. 上班時間：每週至少到班三個整天，其中需包含週一跟週三 4. 學習能力強; 工作認真負責; 做事細心; 對數字有較高之敏感度

Job Overview: Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions: • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. • Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability. • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase. • Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. • Collaborate and liaise with study team members for project execution support as appropriate. • If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. • If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Job Overview: • Services rendered will adhere to applicable Sponsor's SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements, etc. • Complies with relevant training requirements. • Contribute to quality Site Selection through participation in site feasibility ensuring consistent conduct of site qualification visits and appropriate follow-up of site qualification visit report and country feasibility report. Collaborates with central study team and local stakeholders as applicable for final selection of sites to participate in trial. • Ensures local/country team is meeting recruitment targets with high quality data on time and within study budget by providing input to study level documents and leading/coordinating local team activities in compliance with SOPs, other procedural documents and applicable regulations. This may require development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting. • Act as primary company contact for assigned trial at the country level, may attend/participate in Investigator Meetings as needed. May schedule and conduct a local/country investigator meeting. • Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress. When necessary, initiates corrective and preventive actions (CAPA) when the trial deviates from plans and communicates study progress and issues to study management teams and Quality & Compliance team. • Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target. • Delivers competent vendor management at the country level to support the study and may submit requests for vendor services and support vendor selection. This includes reviewing and approving site and local vendor invoices as required. As required, manages the local study supply. • Ensures high standards for study monitoring by conducting quality local trial team meetings and facilitating SM training, when needed. • Ensures trial subject safety in that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented, as appropriate. • Ensures Inspection readiness by maintaining complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS and eTMF/IF) according to expectations (metrics) and archiving retention requirements. When issues are identified or trends across a project are noted from MVR review, will escalate deviation issues to CTM/GTL and Sponsor FM in timely manner. • Keeps oneself inspection ready and knowledgeable for current work by complying with relevant training requirements and developing therapeutic knowledge enough for role and responsibilities. • With focus on quality and compliance, will work closely with SM to ensure CAPA is implemented for audits/inspections or any quality related visits. May conduct accompanied site visits with SM, if delegated by FM. • Ensure accurate finance reporting and trial delivered within budget by adhering to finance reporting deliverables and timelines. This includes forecasting and proactive management of country/local trial budget. If applicable, may assist in negotiation of trial site contracts and budgets. • Keeps the trial in compliance with local regulatory requirements by organizing and ensuring IEC/HA approvals in cooperation with the local Start Up team, if as applicable. • May contribute as a trainer of systems/processes or provide input to functional area in process initiatives, if applicable. • Experience in management and startup of complex Early Phase trials projection with internal matrix clinical teams and sites, as applicable.