CLINICAL TRIAL SUPERVISOR (临床试验主管）社

15K-20K/月

市辖区本科及以上

发布时间：2023-09-06

职位描述

职位描述：



WearegoingtorecruitaClinicalTrialSupervisorforoursubsidiarybasedinShanghai(150employees,100MRMBinSaleswithaggressiveandexcitingplaninChina);thepositionisbasedinadowntownlocationinShanghaiwithregulartripwithinmainlandChinaandoccasionallyinAPACandEurope.
Thisisacompanyoperatinginthepharmaceuticalindustryandthislocallyontheentirevaluechain(development,formulation,production,sales);
TheClinicalTrialSupervisor/ClinicalSearchSupervisorwillreporttoRegulatoryManager.
3yearslocalcontractwith6monthsprobationperiod.

JobResponsibilities:
-Organizeandmanagetheclinicaltrialforthepurposeofregistrationandmarketingpromotion.
-DrafttheprotocolfortheBEstudyandclinicaltrial.
-Responsiblefortheprojectplanandbudgetforclinicaltrial.
-Ensurethatclinicaltrialcompliancewiththepolicies,protocol,scheduleandSOP.
-Participateinthenewproductlaunchactivitiesasamedicalexpertiseforexplainingsomemedicalbackground/clinicalresultsandansweringrelatedquestions.
-CooperateWithotherdepartmentstocarryoutresearchprojectsandtheevaluation,particularlyintheclinicalpartoftheassessment
-Organizeandmanagetheclinicaltrial.Monitortheentireclinicaltrialprocess,familiarwiththeclinicaltrialsfromPhaseItoPhaseIV.
-Responsibleforchoosingtheinstitution,drafttheagreementandnegotiateforclinicaltrial.
-Responsiblefortheprojectallkindofcoordinationworkintheimplementationprocess.KeepandMaintaingoodcommunicationandcoordinationwithresearchers,
-Accordingtothetestingrequirementsfortheprojecttoproperlyestablishandmanagethedocumentation.
-Providetheclinicaltrialdocumentforthedrugregistered.
Marketingmissions
-Keepcontactwithspecialistsinmedicalfieldtoobtaincertainmarketinginformation.
-Regularlyretrievemedicalandmarketinginformationforrelatedproducts.
RelationshipManagement
-Activeparticipation,communicationandcollaborationwithR&Dteam,BD,MarketingandProjectdepartment.
-Creative,Teamplayer,problemsettledandworkunderpressure
-Buildlastingrelationshipswithclientsandprospects
-Maintaingoodworkingrelationshipswithcolleagues,seniorandjuniorcolleaguesacrossthebusinessunit.
MANDATORYKNOWLEDGE–SKILLSANDABILITIES
-Chinesenationalorreturneepreferred(M/F)withmandatoryinternationalexposure(studying,livingorworking)
-FluentandprofessionalEnglishandMandarin(writingandspeaking)–Frenchisabigplus
-Master'sdegreemajorinmedicalscienceorpharmacy
-NaturalcommerciallyorientedandexperiencedinbusinessdevelopmentinpharmaceuticalindustryinChina
-Atleast5yearsrelevantexperiencewithmultinationalpharmaceuticalcompany
-Existingnetworkandrelationshipinpharmaceuticalindustry
-KnowledgeofChinapharmaceuticalsmarket,rulesandregulationsondrugdevelopment
-Clinicalresearchexperience,projectmanagementexperienceandexperienceinclinicaloperations;orequivalentcombinationofeducation,trainingandexperienceindepthknowledgeof,andskillinapplying
-Familiarwithapplicableclinicalresearchregulatoryrequirements;i.e.,GoodClinicalPractice(GCP)andInternationalConferenceonHarmonization(ICH)guidelines
DESIREDKNOWLEDGE–SKILLSANDABILITIES
-Depththerapeuticandprotocolknowledge
-Abilitytosetupthebudgetandcontrolcosts
-Strongorganizationalandproblemsolvingskills
-Demonstratedabilitytodeliverresultstotheappropriatequalityandtimelinemetrics
-Goodteamleadershipskills,goodjudgmentandeffectivepresentationskills
-Establishandmaintaineffectiveworkingrelationshipswithclients.
-Softwareandcomputerskills,includingMSOfficeapplications

其他要求

招聘人数：1人
职能类别：

公司介绍

爱的发制药集团是以研发为主导的国际化药物释放技术公司，公司拥有一系列的药物释放技术平台，可以满足从传统小分子到生物大分子递送的各种要求，基于其全球的5个研发中心和4个生产基地，62组全球性的专利保护，爱的发为客户提供从研发、注册到生产的全方位服务。
目前，公司已经拥有超过1600项的市场授权，为50多个化合物开发了不同的配方，爱的发将产品授权客户，在70多个国家上市，包括诸多知名跨国公司在内的超过200家制药企业选择爱的发作为他们信赖和合作伙伴。
作为第一批中法合作的制药企业，上海爱的发成立于1995年11月，基于其创新的药物释放技术，上海爱的发在中国开发和上市了一系列产品，并为客户提供包括可行性研究、工艺放大、临床实验、注册和工业化生产的全方位服务；作为中国药物释放产业的领军企业，上海爱的发通过提高现有产品的治疗效能和竞争力，帮助合作伙伴延长产品的生命周期和专利保护，而所做的提高和改进都达到或者超过生产规范国际标准的要求。