設(shè)備臨床崗位職責(zé)

TOP外資醫(yī)療器械設(shè)備臨床研究經(jīng)理CRM/ClinicalResearchManagerSpanofControl(Immediatesubordinates’category,numberandinterfaces)負(fù)責(zé)范圍(直接下屬類(lèi)別、人數(shù)及主要互動(dòng)界面):

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

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

JobSummary(OverviewofJobPurpose)職位概述以及職責(zé)范圍:

FunctionasaprojectleadertomanageandcoordinateallAvitum’sclinicalresearchprojectsandrelatedmedicalaffairs.

MajorDutiesPerformed(MainFunctions)主要職責(zé):

-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關(guān)鍵業(yè)績(jī)標(biāo)準(zhǔn):

-4ongoingclinicaltrialsmilestoneachievements,acceleratethewholestudydurationinto1year,optimizeCROandvendormanagementforhigherprojectquality.

-Crossfunctionalcollaborationsatisfaction.

-ProjectManagement&communicationskill.

Education&LanguageskillsRequired

教育背景及語(yǔ)言技能要求:

Bachelor/masterinMedical,Pharmaceutical,Biomedical

FluentinEnglish

Office(projectmanagement)

Experience&SpecialSkillsRequired

經(jīng)驗(yàn)及其他特殊技能要求:

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

ClinicaltrialexperienceinMedicalDevice/Pharmaceutical

CROexperienceispreferred

GCPCertification,ProjectManagementcertificateispreferredSpanofControl(Immediatesubordinates’category,numberandinterfaces)負(fù)責(zé)范圍(直接下屬類(lèi)別、人數(shù)及主要互動(dòng)界面):

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

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

JobSummary(OverviewofJobPurpose)職位概述以及職責(zé)范圍:

FunctionasaprojectleadertomanageandcoordinateallAvitum’sclinicalresearchprojectsandrelatedmedicalaffairs.

MajorDutiesPerformed(MainFunctions)主要職責(zé):

-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關(guān)鍵業(yè)績(jī)標(biāo)準(zhǔn):

-4ongoingclinicaltrialsmilestoneachievements,acceleratethewholestudydurationinto1year,optimizeCROandvendormanagementforhigherprojectquality.

-Crossfunctionalcollaborationsatisfaction.

-ProjectManagement&communicationskill.

Education&LanguageskillsRequired

教育背景及語(yǔ)言技能要求:

Bachelor/masterinMedical,Pharmaceutical,Biomedical

FluentinEnglish

Office(projectmanagement)

Experience&SpecialSkillsRequired

經(jīng)驗(yàn)及其他特殊技能要求:

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

ClinicaltrialexperienceinMedicalDevice/Pharmaceutical

CROexperienceispreferred

GCPCertification,ProjectManagementcertificateispreferred

篇2:臨床實(shí)驗(yàn)室(檢驗(yàn)科)設(shè)備維修和保養(yǎng)基本準(zhǔn)則

　　臨床實(shí)驗(yàn)室(檢驗(yàn)科)設(shè)備維修和保養(yǎng)基本準(zhǔn)則

　　臨床實(shí)驗(yàn)室設(shè)備使用和管理的核心任務(wù)應(yīng)該是使設(shè)備“能夠達(dá)到規(guī)定的性能標(biāo)準(zhǔn)，并且符合相關(guān)檢驗(yàn)所要求的規(guī)格”，其目的就是為了保證實(shí)驗(yàn)室設(shè)備能夠正常、有效運(yùn)行，其性能符合相關(guān)檢驗(yàn)的要求，確保檢驗(yàn)結(jié)果的正確和可靠。臨床實(shí)驗(yàn)室設(shè)備使用和管理涉及設(shè)備整個(gè)使用周期，包括設(shè)備的采購(gòu)計(jì)劃編制與選購(gòu)、設(shè)備安裝與驗(yàn)收、設(shè)備標(biāo)識(shí)、設(shè)備檔案、設(shè)備的檢定/校準(zhǔn)、設(shè)備的使用、設(shè)備維修和保養(yǎng)、設(shè)備報(bào)廢等內(nèi)容。

　　正確的設(shè)備維修和保養(yǎng)是保證設(shè)備正常運(yùn)行的前提，臨床實(shí)驗(yàn)室必須根據(jù)制造商建議或行業(yè)規(guī)范要求進(jìn)行設(shè)備維修和保養(yǎng)。

一、設(shè)備維修

　　1.當(dāng)儀器出現(xiàn)故障時(shí)，應(yīng)停止運(yùn)行，報(bào)告臨床實(shí)驗(yàn)室相關(guān)負(fù)責(zé)人，進(jìn)行報(bào)修，同時(shí)應(yīng)立即更換儀器狀態(tài)標(biāo)識(shí)。清楚標(biāo)記后妥善存放至其被修復(fù)，應(yīng)經(jīng)校準(zhǔn)、驗(yàn)證或檢測(cè)表明其達(dá)到規(guī)定的可接受標(biāo)準(zhǔn)后方可使用。臨床實(shí)驗(yàn)室應(yīng)檢查上述故障對(duì)之前檢驗(yàn)的影響。

　　2.儀器維修前，應(yīng)進(jìn)行去污染處理，并溫馨提示和告知工程師此設(shè)備可能存在生物安全方面風(fēng)險(xiǎn)應(yīng)采取必要的預(yù)防措施，降低感染的機(jī)會(huì)，確保維修工程師安全。

　　3.有符合要求的替用或備用設(shè)備時(shí)，啟用替用或備用設(shè)備。借用其他部門(mén)設(shè)備時(shí)，應(yīng)核實(shí)該設(shè)備的性能和使用狀態(tài)。替用或備用的設(shè)備、借用的設(shè)備在滿(mǎn)足質(zhì)量要求的同時(shí)，必須同時(shí)滿(mǎn)足臨床實(shí)驗(yàn)室管理措施的要求。

　　4.設(shè)備維修后應(yīng)出具維修報(bào)告，維修報(bào)告內(nèi)容至少應(yīng)包括以下內(nèi)容：維修的儀器或設(shè)備名稱(chēng)與設(shè)備編號(hào)、故障發(fā)生日期、故障描述、設(shè)備參數(shù)/設(shè)置故障排除的日期和時(shí)間、故障維修人員簽字確認(rèn)、故障排除后所采取的后續(xù)行動(dòng)(如果需要的話(huà))、檢驗(yàn)科(實(shí)驗(yàn)室)相關(guān)負(fù)責(zé)人的審核和批準(zhǔn)等。

　　5.設(shè)備維修后應(yīng)有維修報(bào)告并存檔，儀器維修后需經(jīng)過(guò)校準(zhǔn)、驗(yàn)證，或檢測(cè)表明其達(dá)到規(guī)定的可接受標(biāo)準(zhǔn)，并經(jīng)臨床實(shí)驗(yàn)室負(fù)責(zé)人審核后方能投入使用。校準(zhǔn)，驗(yàn)證和對(duì)故障前所檢測(cè)項(xiàng)目的結(jié)果評(píng)估與驗(yàn)證可以根據(jù)故障的部位以及對(duì)檢驗(yàn)結(jié)果的影響程度來(lái)進(jìn)行確定。

二、設(shè)備保養(yǎng)

　　臨床實(shí)驗(yàn)室應(yīng)遵循制造商的建議，制定每臺(tái)設(shè)備的維護(hù)與保養(yǎng)程序，并嚴(yán)格按程序?qū)υO(shè)備進(jìn)行常規(guī)性維護(hù)和保養(yǎng)，并記錄。

　　1.應(yīng)根據(jù)臨床實(shí)驗(yàn)室儀器設(shè)備制造商的建議制定定期(每日、每周、每月等)日常預(yù)防性維護(hù)和保養(yǎng)及年度維護(hù)保養(yǎng)計(jì)劃。

　　2.臨床實(shí)驗(yàn)室儀器使用人員按該儀器計(jì)劃規(guī)定定期進(jìn)行日常預(yù)防性維護(hù)和保養(yǎng)，并記錄設(shè)備的狀態(tài)、使用情況、維護(hù)和保養(yǎng)情況。

　　3.每臺(tái)設(shè)備年度維護(hù)由廠商工程師進(jìn)行，并對(duì)維護(hù)保養(yǎng)的過(guò)程作詳細(xì)記錄，并經(jīng)實(shí)驗(yàn)室相關(guān)負(fù)責(zé)人審核、確認(rèn)。