设备临床岗位职责设备临床职责任职要求

设备临床岗位职责

TOP外资医疗器械设备临床研究经理CRM/ClinicalResearchManagerSpanofControl(Immediatesubordinates’category,numberandinterfaces)负责范围(直接下属类别、人数及主要互动界面):

Internal:GlobalMedicalScienceAffairs,RegulatoryAffair,Sales&Marketing,IT,FinanceandLegal

External:Hospitals,ClinicalResearchOrganization(CRO),DataManagement,Statisticians,CRCandothervendors

JobSummary(OverviewofJobPurpose)职位概述以及职责范围:

FunctionasaprojectleadertomanageandcoordinateallAvitum’sclinicalresearchprojectsandrelatedmedicalaffairs.

MajorDutiesPerformed(MainFunctions)主要职责:

-Performstudystart-upactivities,includingstudyplanbuild-up,studyprotocolandCRFdesign,InvestigatorMeeting,ECandMOSTapproval,siteselection,siteinitiation,E-Trialdevelopment,co-monitoring,studyclosureandotherrelatedactivitiesensuringcompliancewithCFDAregulation,GCP/ICHguidelinesandcompanySOPs.

-Allocatethebudgetbyprojectandconductthedailymanagementandupdatetheusagestatus.

-Documentandupdatedtheprogressofassignedclinicalstudiesthroughregularstatusreport.

-ProvidedirectionandoversightofoutsourcedactivitiestoensureClinicalResearchOrganization(CRO)andvendorsdeliveryagainstcontractedscopeofwork.

-CollaboratewithcrossfunctionaldepartmentsuchasGlobalMedicalScienceAffairs,RegulatoryAffair,Sales&Marketing,IT,FinanceandLegaltosupportprojectmilestoneachievement.Provideclinicaltrialdossierforregistrationuse.

-CoordinatemedicalaffairstaskssuchasPostMarketingClinicalProjects,ClinicalEvaluationReport,publication.

-AssisttheSr.ClinicalResearchManagerinbuildingtheMSAnetworkandadditionalresponsibilitiesasrequired.

CriticalPerformanceMeasurement关键业绩标准:

-4ongoingclinicaltrialsmilestoneachievements,acceleratethewholestudydurationinto1year,optimizeCROandvendormanagementforhigherprojectquality.

-Crossfunctionalcollaborationsatisfaction.

-ProjectManagement&communicationskill.

Education&LanguageskillsRequired

教育背景及语言技能要求:

Bachelor/masterinMedical,Pharmaceutical,Biomedical

FluentinEnglish

Office(projectmanagement)

Experience&SpecialSkillsRequired

经验及其他特殊技能要求:

Totalworkingexperience8+Y(5+YSr.CRAexperience,3+Yprojectmanagement)

ClinicaltrialexperienceinMedicalDevice/Pharmaceutical

CROexperienceispreferred

GCPCertification,ProjectManagementcertificateispreferredSpanofControl(Immediatesubordinates’category,numberandinterfaces)负责范围(直接下属类别、人数及主要互动界面):

Internal:GlobalMedicalScienceAffairs,RegulatoryAffair,Sales&Marketing,IT,FinanceandLegal

External:Hospitals,ClinicalResearchOrganization(CRO),DataManagement,Statisticians,CRCandothervendors

JobSummary(OverviewofJobPurpose)职位概述以及职责范围:

FunctionasaprojectleadertomanageandcoordinateallAvitum’sclinicalresearchprojectsandrelatedmedicalaffairs.

MajorDutiesPerformed(MainFunctions)主要职责:

-Performstudystart-upactivities,includingstudyplanbuild-up,studyprotocolandCRFdesign,InvestigatorMeeting,ECandMOSTapproval,siteselection,siteinitiation,E-Trialdevelopment,co-monitoring,studyclosureandotherrelatedactivitiesensuringcompliancewithCFDAregulation,GCP/ICHguidelinesandcompanySOPs.

-Allocatethebudgetbyprojectandconductthedailymanagementandupdatetheusagestatus.

-Documentandupdatedtheprogressofassignedclinicalstudiesthroughregularstatusreport.

-ProvidedirectionandoversightofoutsourcedactivitiestoensureClinicalResearchOrganization(CRO)andvendorsdeliveryagainstcontractedscopeofwork.

-CollaboratewithcrossfunctionaldepartmentsuchasGlobalMedicalScienceAffairs,RegulatoryAffair,Sales&Marketing,IT,FinanceandLegaltosupportprojectmilestoneachievement.Provideclinicaltrialdossierforregistrationuse.

-CoordinatemedicalaffairstaskssuchasPostMarketingClinicalProjects,ClinicalEvaluationReport,publication.

-AssisttheSr.ClinicalResearchManagerinbuildingtheMSAnetworkandadditionalresponsibilitiesasrequired.

CriticalPerformanceMeasurement关键业绩标准:

-4ongoingclinicaltrialsmilestoneachievements,acceleratethewholestudydurationinto1year,optimizeCROandvendormanagementforhigherprojectquality.

-Crossfunctionalcollaborationsatisfaction.

-ProjectManagement&communicationskill.

Education&LanguageskillsRequired

教育背景及语言技能要求:

Bachelor/masterinMedical,Pharmaceutical,Biomedical

FluentinEnglish

Office(projectmanagement)

Experience&SpecialSkillsRequired

经验及其他特殊技能要求:

Totalworkingexperience8+Y(5+YSr.CRAexperience,3+Yprojectmanagement)

ClinicaltrialexperienceinMedicalDevice/Pharmaceutical

CROexperienceispreferred

GCPCertification,ProjectManagementcertificateispreferred

制度大全 www.QiquHa.com.com

篇2:临床实验室(检验科)设备维修和保养基本准则

　　临床实验室(检验科)设备维修和保养基本准则

　　临床实验室设备使用和管理的核心任务应该是使设备“能够达到规定的性能标准，并且符合相关检验所要求的规格”，其目的就是为了保证实验室设备能够正常、有效运行，其性能符合相关检验的要求，确保检验结果的正确和可靠。临床实验室设备使用和管理涉及设备整个使用周期，包括设备的采购计划编制与选购、设备安装与验收、设备标识、设备档案、设备的检定/校准、设备的使用、设备维修和保养、设备报废等内容。

　　正确的设备维修和保养是保证设备正常运行的前提，临床实验室必须根据制造商建议或行业规范要求进行设备维修和保养。

一、设备维修

　　1.当仪器出现故障时，应停止运行，报告临床实验室相关负责人，进行报修，同时应立即更换仪器状态标识。清楚标记后妥善存放至其被修复，应经校准、验证或检测表明其达到规定的可接受标准后方可使用。临床实验室应检查上述故障对之前检验的影响。

　　2.仪器维修前，应进行去污染处理，并温馨提示和告知工程师此设备可能存在生物安全方面风险应采取必要的预防措施，降低感染的机会，确保维修工程师安全。

　　3.有符合要求的替用或备用设备时，启用替用或备用设备。借用其他部门设备时，应核实该设备的性能和使用状态。替用或备用的设备、借用的设备在满足质量要求的同时，必须同时满足临床实验室管理措施的要求。

　　4.设备维修后应出具维修报告，维修报告内容至少应包括以下内容：维修的仪器或设备名称与设备编号、故障发生日期、故障描述、设备参数/设置故障排除的日期和时间、故障维修人员签字确认、故障排除后所采取的后续行动(如果需要的话)、检验科(实验室)相关负责人的审核和批准等。

　　5.设备维修后应有维修报告并存档，仪器维修后需经过校准、验证，或检测表明其达到规定的可接受标准，并经临床实验室负责人审核后方能投入使用。校准，验证和对故障前所检测项目的结果评估与验证可以根据故障的部位以及对检验结果的影响程度来进行确定。

二、设备保养

　　临床实验室应遵循制造商的建议，制定每台设备的维护与保养程序，并严格按程序对设备进行常规性维护和保养，并记录。

　　1.应根据临床实验室仪器设备制造商的建议制定定期(每日、每周、每月等)日常预防性维护和保养及年度维护保养计划。

　　2.临床实验室仪器使用人员按该仪器计划规定定期进行日常预防性维护和保养，并记录设备的状态、使用情况、维护和保养情况。

　　3.每台设备年度维护由厂商工程师进行，并对维护保养的过程作详细记录，并经实验室相关负责人审核、确认。

篇3:设备临床岗位职责设备临床职责任职要求

设备临床岗位职责

TOP外资医疗器械设备临床研究经理CRM/ClinicalResearchManagerSpanofControl(Immediatesubordinates’category,numberandinterfaces)负责范围(直接下属类别、人数及主要互动界面):

Internal:GlobalMedicalScienceAffairs,RegulatoryAffair,Sales&Marketing,IT,FinanceandLegal

External:Hospitals,ClinicalResearchOrganization(CRO),DataManagement,Statisticians,CRCandothervendors

JobSummary(OverviewofJobPurpose)职位概述以及职责范围:

FunctionasaprojectleadertomanageandcoordinateallAvitum’sclinicalresearchprojectsandrelatedmedicalaffairs.

MajorDutiesPerformed(MainFunctions)主要职责:

-Performstudystart-upactivities,includingstudyplanbuild-up,studyprotocolandCRFdesign,InvestigatorMeeting,ECandMOSTapproval,siteselection,siteinitiation,E-Trialdevelopment,co-monitoring,studyclosureandotherrelatedactivitiesensuringcompliancewithCFDAregulation,GCP/ICHguidelinesandcompanySOPs.

-Allocatethebudgetbyprojectandconductthedailymanagementandupdatetheusagestatus.

-Documentandupdatedtheprogressofassignedclinicalstudiesthroughregularstatusreport.

-ProvidedirectionandoversightofoutsourcedactivitiestoensureClinicalResearchOrganization(CRO)andvendorsdeliveryagainstcontractedscopeofwork.

-CollaboratewithcrossfunctionaldepartmentsuchasGlobalMedicalScienceAffairs,RegulatoryAffair,Sales&Marketing,IT,FinanceandLegaltosupportprojectmilestoneachievement.Provideclinicaltrialdossierforregistrationuse.

-CoordinatemedicalaffairstaskssuchasPostMarketingClinicalProjects,ClinicalEvaluationReport,publication.

-AssisttheSr.ClinicalResearchManagerinbuildingtheMSAnetworkandadditionalresponsibilitiesasrequired.

CriticalPerformanceMeasurement关键业绩标准:

-4ongoingclinicaltrialsmilestoneachievements,acceleratethewholestudydurationinto1year,optimizeCROandvendormanagementforhigherprojectquality.

-Crossfunctionalcollaborationsatisfaction.

-ProjectManagement&communicationskill.

Education&LanguageskillsRequired

教育背景及语言技能要求:

Bachelor/masterinMedical,Pharmaceutical,Biomedical

FluentinEnglish

Office(projectmanagement)

Experience&SpecialSkillsRequired

经验及其他特殊技能要求:

Totalworkingexperience8+Y(5+YSr.CRAexperience,3+Yprojectmanagement)

ClinicaltrialexperienceinMedicalDevice/Pharmaceutical

CROexperienceispreferred

GCPCertification,ProjectManagementcertificateispreferredSpanofControl(Immediatesubordinates’category,numberandinterfaces)负责范围(直接下属类别、人数及主要互动界面):

Internal:GlobalMedicalScienceAffairs,RegulatoryAffair,Sales&Marketing,IT,FinanceandLegal

External:Hospitals,ClinicalResearchOrganization(CRO),DataManagement,Statisticians,CRCandothervendors

JobSummary(OverviewofJobPurpose)职位概述以及职责范围:

FunctionasaprojectleadertomanageandcoordinateallAvitum’sclinicalresearchprojectsandrelatedmedicalaffairs.

MajorDutiesPerformed(MainFunctions)主要职责:

-Performstudystart-upactivities,includingstudyplanbuild-up,studyprotocolandCRFdesign,InvestigatorMeeting,ECandMOSTapproval,siteselection,siteinitiation,E-Trialdevelopment,co-monitoring,studyclosureandotherrelatedactivitiesensuringcompliancewithCFDAregulation,GCP/ICHguidelinesandcompanySOPs.

-Allocatethebudgetbyprojectandconductthedailymanagementandupdatetheusagestatus.

-Documentandupdatedtheprogressofassignedclinicalstudiesthroughregularstatusreport.

-ProvidedirectionandoversightofoutsourcedactivitiestoensureClinicalResearchOrganization(CRO)andvendorsdeliveryagainstcontractedscopeofwork.

-CollaboratewithcrossfunctionaldepartmentsuchasGlobalMedicalScienceAffairs,RegulatoryAffair,Sales&Marketing,IT,FinanceandLegaltosupportprojectmilestoneachievement.Provideclinicaltrialdossierforregistrationuse.

-CoordinatemedicalaffairstaskssuchasPostMarketingClinicalProjects,ClinicalEvaluationReport,publication.

-AssisttheSr.ClinicalResearchManagerinbuildingtheMSAnetworkandadditionalresponsibilitiesasrequired.

CriticalPerformanceMeasurement关键业绩标准:

-4ongoingclinicaltrialsmilestoneachievements,acceleratethewholestudydurationinto1year,optimizeCROandvendormanagementforhigherprojectquality.

-Crossfunctionalcollaborationsatisfaction.

-ProjectManagement&communicationskill.

Education&LanguageskillsRequired

教育背景及语言技能要求:

Bachelor/masterinMedical,Pharmaceutical,Biomedical

FluentinEnglish

Office(projectmanagement)

Experience&SpecialSkillsRequired

经验及其他特殊技能要求:

Totalworkingexperience8+Y(5+YSr.CRAexperience,3+Yprojectmanagement)

ClinicaltrialexperienceinMedicalDevice/Pharmaceutical

CROexperienceispreferred

GCPCertification,ProjectManagementcertificateispreferred