臨床試驗工程師崗位職責任職要求
臨床試驗工程師崗位職責
法規工程師/臨床試驗工程師開立生物深圳開立生物醫療科技股份有限公司【任職要求】
1、負責國內外注冊項目,能獨立編寫合規的注冊認證文檔,與藥監部門聯系,體系審核等;
2、負責產品開發過程中的法規輸入相關工作;
3、醫療器械法規標準貫徹實施。
【具體要求】
1、相關醫療器械專業,本科以上學歷;
2、兩年以上注冊認證相關經驗;
3、英語良好,能夠閱讀相關的英文技術資料和文獻;
4、責任心強、學習能力強,具有良好的溝通技巧和協調能力。
臨床試驗工程師崗位
篇2:設備臨床崗位職責設備臨床職責任職要求
設備臨床崗位職責
TOP外資醫療器械設備臨床研究經理CRM/ClinicalResearchManagerSpanofControl(Immediatesubordinates’category,numberandinterfaces)負責范圍(直接下屬類別、人數及主要互動界面):
Internal:GlobalMedicalScienceAffairs,RegulatoryAffair,Sales&Marketing,IT,FinanceandLegal
External:Hospitals,ClinicalResearchOrganization(CRO),DataManagement,Statisticians,CRCandothervendors
JobSummary(OverviewofJobPurpose)職位概述以及職責范圍:
FunctionasaprojectleadertomanageandcoordinateallAvitum’sclinicalresearchprojectsandrelatedmedicalaffairs.
MajorDutiesPerformed(MainFunctions)主要職責:
-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關鍵業績標準:
-4ongoingclinicaltrialsmilestoneachievements,acceleratethewholestudydurationinto1year,optimizeCROandvendormanagementforhigherprojectquality.
-Crossfunctionalcollaborationsatisfaction.
-ProjectManagement&communicationskill.
Education&LanguageskillsRequired
教育背景及語言技能要求:
Bachelor/masterinMedical,Pharmaceutical,Biomedical
FluentinEnglish
Office(projectmanagement)
Experience&SpecialSkillsRequired
經驗及其他特殊技能要求:
Totalworkingexperience8+Y(5+YSr.CRAexperience,3+Yprojectmanagement)
ClinicaltrialexperienceinMedicalDevice/Pharmaceutical
CROexperienceispreferred
GCPCertification,ProjectManagementcertificateispreferredSpanofControl(Immediatesubordinates’category,numberandinterfaces)負責范圍(直接下屬類別、人數及主要互動界面):
Internal:GlobalMedicalScienceAffairs,RegulatoryAffair,Sales&Marketing,IT,FinanceandLegal
External:Hospitals,ClinicalResearchOrganization(CRO),DataManagement,Statisticians,CRCandothervendors
JobSummary(OverviewofJobPurpose)職位概述以及職責范圍:
FunctionasaprojectleadertomanageandcoordinateallAvitum’sclinicalresearchprojectsandrelatedmedicalaffairs.
MajorDutiesPerformed(MainFunctions)主要職責:
-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關鍵業績標準:
-4ongoingclinicaltrialsmilestoneachievements,acceleratethewholestudydurationinto1year,optimizeCROandvendormanagementforhigherprojectquality.
-Crossfunctionalcollaborationsatisfaction.
-ProjectManagement&communicationskill.
Education&LanguageskillsRequired
教育背景及語言技能要求:
Bachelor/masterinMedical,Pharmaceutical,Biomedical
FluentinEnglish
Office(projectmanagement)
Experience&SpecialSkillsRequired
經驗及其他特殊技能要求:
Totalworkingexperience8+Y(5+YSr.CRAexperience,3+Yprojectmanagement)
ClinicaltrialexperienceinMedicalDevice/Pharmaceutical
CROexperienceispreferred
GCPCertification,ProjectManagementcertificateispreferred
篇3:臨床咨詢醫師崗位職責任職要求
臨床咨詢醫師崗位職責
崗位職責:
1、解答客戶關于疾病治療、預防及身體保健方面的疑問,根據顧客身體實際情況給出輔助治療及預防保健方案;
2、對員工進行相關醫學基礎知識的培訓;
3、擔任公司組織的有關醫學報告會的講師,積極傳播健康文化。
任職要求:
1、不限,醫學等相關專業大專以上應往屆畢業生均可;
2、具有臨床醫學等相關工作經驗者優先;
3、思維敏捷、有條理,語言表達清晰、流暢;
本崗位繳納五險,公司提供免費住宿,每月發放員工福利,每年組織一次3-4天的大型旅游,月均工資在4000元以上。(薪資可面議)
臨床咨詢醫師崗位