临床试验工程师岗位职责任职要求
临床试验工程师岗位职责
法规工程师/临床试验工程师开立生物深圳开立生物医疗科技股份有限公司【任职要求】
1、负责国内外注册项目,能独立编写合规的注册认证文档,与药监部门联系,体系审核等;
2、负责产品开发过程中的法规输入相关工作;
3、医疗器械法规标准贯彻实施。
【具体要求】
1、相关医疗器械专业,本科以上学历;
2、两年以上注册认证相关经验;
3、英语良好,能够阅读相关的英文技术资料和文献;
4、责任心强、学习能力强,具有良好的沟通技巧和协调能力。
临床试验工程师岗位
篇2: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
篇3:临床咨询医师岗位职责任职要求
临床咨询医师岗位职责
岗位职责:
1、解答客户关于疾病治疗、预防及身体保健方面的疑问,根据顾客身体实际情况给出辅助治疗及预防保健方案;
2、对员工进行相关医学基础知识的培训;
3、担任公司组织的有关医学报告会的讲师,积极传播健康文化。
任职要求:
1、不限,医学等相关专业大专以上应往届毕业生均可;
2、具有临床医学等相关工作经验者优先;
3、思维敏捷、有条理,语言表达清晰、流畅;
本岗位缴纳五险,公司提供免费住宿,每月发放员工福利,每年组织一次3-4天的大型旅游,月均工资在4000元以上。(薪资可面议)
临床咨询医师岗位