【文章內(nèi)容簡(jiǎn)介】 0。 受試者 Subject Enrollment 受試者入選Subject Enrollment Log 受試者入選表Subject Identification Code List 受試者識(shí)別代碼表Subject Recruitment 受試者招募Study Site 研究中心Subject Screening Log 受試者篩選表System Audit 系統(tǒng)稽查Test Product 受試制劑 Trial Initial Meeting 試驗(yàn)啟動(dòng)會(huì)議Trial Master File 試驗(yàn)總檔案Trial Objective 試驗(yàn)?zāi)康腡riple Blinding 三盲Washout 洗脫Washout Period 洗脫期introductionQuintiles Transnational Corp. helps improve healthcare worldwide by providing a broad range of professional services, information and partnering solutions to the pharmaceutical, biotechnology and healthcare industries. Quintiles helps its customers press the time it takes to bring a drug from discovery through regulatory approval。 accelerate the launch of products to peak sales, build effective sales forces and manage product portfolios more efficiently。 and achieve strategic and financial objectives by offering tailored alternatives to traditional feeforservice product development and mercial services agreements. Headquartered near Research Triangle Park, North Carolina, Quintiles was founded in 1982 and has more than 16,000 employees and offices in over 50 countries. Quintiles Medical Development (Shanghai) Co., Ltd. is a wholly owned subsidiary of Quintiles Transnational Corp. Further information, please visit our global website Job title:Clinical Project Manager(臨床項(xiàng)目經(jīng)理)RESPONSIBILITIESManage and coordinate efforts of crossfunctional project teams to support milestone achievement and to manage study issues and obstacles and ensure consistent use of study tools and training materials and pliance with standard processes, policies and procedures.Develop study management plans, together with team assignments and accountabilities and oversight of database maintenance.Serve as primary project contact with Sponsor to ensure munication is maintained and reporting schedules are adhered to.Collect information on team performance against contract, customer expectations, and project baselines.Lead problem solving and resolution efforts to include management of risk, contingencies and issues.Identify quality issues within the study to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties.Provide input for the development of proposals for new work and manage project budgets.Provide input to line managers of their project team members39。 performance relative to project tasks.Prepare and present project information at internal and external meetings.Participate in proposal development and in the biddefense process with guidance and supervision.Ensure high performance and efficiency of the clinical team through the scheduling of comonitoring/acpanied site/visits and ongoing mentoring of CRA team.REQUIRED KNOWLEDGE, SKILLS AND ABILITIESIn depth knowledge of, and skill in applying, applicable clinical research regulatory requirements。 ., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelinesGood therapeutic and protocol knowledgeStrong munication and interpersonal skills, including good mand of English languageGood problem solving skillsDemonstrated ability to deliver results to the appropriate quality and timeline metricsGood teamwork skillsExcellent customer service skillsGood presentation skillsGood judgmentStrong software and puter skills, including MS Office applicationsAbility to establish and maintain effective working relationships with coworkers, managers and clientsMINIMUM REQUIRED EDUCATION AND EXPERIENCEBachelor39。s degree in life sciences or related field and 5 years39。 clinical research experience including 2 years39。 project management experience and experience in clinical operations。 or equivalent bination of education, training and experience. Job title:Clinical Trials AssistantLocation:BeijingResponsibilitiesAssist Clinical Team Lead (CTL) and Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems that track site pliance 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 accuracy and pleteness.Assist CTLs 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 munications, correspondence and associated documentation.May perform assigned administrative tasks to support team members with clinical trial execution.All responsibilities are essential job functions unless noted as nonessential (N).Required kno