Project Specialist

该职位是精鼎医药（Parexel）的项目专员，主要负责协助项目领导维护项目管理计划、更新系统工具、生成报告和分析，并支持临床试验运营

Key Accountabilities include but are not limited to: Project Management Plans initial set up and maintenance with Project Leader input; Maintenance of selected information in the integrated project management system; Project reports, compliance and other metrics for project operational review, client and internal reporting and project oversight; Initial Review of selected financial areas; Cooperation with Project Leader and Functional Leads on action plans and follow up with the project team on action items; Oversight of project team list, project system accesses and respective reviews; Project Initiation Management: Updating and customizing of systems and tools and project plans according to applicable SOPs; Supporting vendor selection; Creating of Project specific training curriculum; Reviewing time booking and following up on needed corrections analyzing overconsumption with FL input ready for PL review; Reviewing pass-through costs; Cooperating with TMF lead, IPO and eCBL on set up on TMF and site pay; Cooperating with Project Data Coordinator to set up system access management process; Working with PL and FLs to ensure project resources are requested in line with project scope; Collecting, distributing and tracking insurances and Letter of Authorization. Project Execution and Control Management: Study reporting and distribution to FLs and project team; Maintaining systems and tools according to applicable SOPs. Project Integration Management: Maintaining consistent coherent project management plans, reviewing plans with PL and distributing to the different functions; Reviewing pass-through costs; Reviewing Project Specific Training Compliance and following up on non-compliances; Assisting with preparation and action follow of Project Operational review meetings; Providing reports, metrics and initial analysis for informed Project Leader decision making and client reporting; Maintaining oversight on project system accesses and review. Project Meeting Management: Project meetings preparation and attendance; Supporting preparation of required information for internal and client meetings; Supporting tracking and follow-up of action items. Project Vendor Management: Collaborating with PL and FLs to ensure study supplies are delivered as required and according to contract obligation; Performing vendor invoice review. Project Closure Management: Close out responsibilities: utilizing the close out checklist and communicating to drive timely operational projects close out with the different functions; Collaborating with PL on ensuring that systems are closed, documents are archived, and final work is handed over to the sponsor; Support preparation of the financial close-out. Clinical Operations Leader Support: Supporting the Clinical Operations Leader with different responsibilities to manage CTMS system compliance, site newsletters track and analyze different reports such as site staff lists, shipment reports, laboratory reports, site contact reports, site closure activities related tracking, vendor reports, query reports and other responsibilities as delegated. SME/Mentor, if assigned: Train and mentor new starters in systems and tools. Provide feedback to PS/PL Super User in CRS technology on systems and tools in order to enhance tools and processes.