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臨床事務崗位職責要求

2024-07-29 閱讀 4902

職位描述

崗位職責

負責上市前臨床相關工作,臨床試驗、對接CRO,跟進臨床試驗的執行和進度;臨床評估報告的撰寫。

根據臨床指導原則,撰寫臨床評估報告;

提供產品相關的介紹,就臨床實驗方案與醫師進行學術交流和組織研討會;

負責檢索醫學文獻。

職位要求

臨床醫學、臨床工程相關本科及以上學歷;

5年以上臨床事務經驗;

英文聽說讀寫流利;

良好的溝通能力;

職位要求

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