五百強醫藥化工企業招臨床研究經理崗位職責職位要求
職責描述:
PURPOSEOFTHEROLEResponsibleformanagingoutsourcingofclinicalresearchrelatedtaskstoexternalserviceprovidersonaglobalbasis.LeadandmanagelocalSPMgroupifindicated.
MAININTERFACES
INTERNALLY:GlobalClinicalOperations,Legal,Finance,CQA,Insurance,ClinicalTrialSupplies,Regulatory,Safety,GPDUs,etc.EXTERNALLY:ContractResearchOrganizations(CROs),clinicalandnon-clinicalvendorsasneeded.
KEYTASKS&RESPONSIBILITIES
ResponsibleformanagingoutsourcingofDevelopmentrelatedtasksincooperationwithprojectteamsduringthelifecycleofaprojectSupportstheidentificationofoutsourcingneedstogetherwithinternalcustomersResponsibleforpreparationofsufficientlydetailedrequestforproposaldocumentsincooperationwiththeinternalcustomersResponsibleforthecontractnegotiationswithserviceprovidersincludingallprecedingandsubsequentcontactsResponsibletoascertaintheappropriateandtimelyinvolvementoflegaldepartmentandotherinterfaces(i.e.tax,controlling,QA,etc.)duringallstagesofcontractmanagementResponsibleforanoptimalbalancebetweentime,costandqualityconsiderationsincontractnegotiationstakingintoaccountMerck’sglobalbusinessobjectivesaswellastheDevelopmentoutsourcingstrategyandtheindividualprojectneedsResponsibleforcoordinationandmanagementofstructuredevaluationsofexistingpreferredserviceprovidersandothervendorsofrelevanceforMerckSeronoResponsiblefortheidentificationofnewserviceprovidersinthecontextofregularmarketsurveysSupportsthemaintenanceofalistofpreferred/qualifiedserviceproviders(incl.acatalogueofavailableservices)ResponsibleforvendorrelationshipmanagementResponsibleforestablishmentandmaintenanceofcommunicationplatformswithinternalcustomers
KEYTASKS&RESPONSIBILITIES(continuation)
Responsiblefordevelopmentandmaintenanceoftemplatemodulestofacilitateandspeedupthepreparationofconciseproject-specificrequestsforproposalsResponsiblefordevelopmentofcontractmodulesandbudgetstructurestobepreferablyusedforcontractsResponsibleforconductingalloutsourcingactivitiesandbusinesscontactsincompliancewithMerck'sCodeofConduct,existingQualityDocuments,andallapplicableGuidelinesandPoliciesaswellasapplicablelawsandregulationsSupportsthemaintenanceandfurtherevolutionofelectronicdocumentmanagementandcontractarchivalproceduresSupportsthedevelopmentandadaptationofCOPMbusinessprocedures(incl.QualityDocuments)SupportsthedefinitionofMerckSeronoDevelopmentoutsourcingstrategy
CANDIDATE’SPROFILE
EDUCATION/LANGUAGESDegreeinascientificormedicalorbusinessdiscipline·FluentinspokenandwrittenEnglishPROFESSIONALSKILLS&EXPERIENCE5yearsofexperienceindrugdevelopmentinapharmaceuticalindustryorCROProcurementexpertise(preferablyinclinicalresearchorserviceprocurement)Soundbackgroundoffinancial/controllingissuesPERSONALSKILLS&COMPETENCIESGoodanalyticalandstrategicthinkingAbilitytoworkinamulti-culturalatmosphereAbilitytounderstandandleadinamulti-culturalatmosphereHighlydevelopedwrittenandverbalcommunicationskillsExcellentnegotiationskillsPreparednesstotravelStrongcustomerfocusProactiveandself-motivating
崗位要求:
學歷要求:不限
語言要求:不限
年齡要求:不限
工作年限:無工作經驗
篇2:臨床研究經理職位描述與崗位職責任職要求
職位描述:
崗位職責:
1、按照項目管理的規范流程統籌項目執行,制定項目管理計劃,組建項目組,組織內部培訓及會議,統籌管理項目從調研到研究結束資料移交的全過程。
2、在項目管理的過程中嚴格執行公司SOP,反饋執行的系統問題,協助優化項目管理體系和流程。
3、監督及指導各項目組按照項目階段開展項目專業及技能培訓,確保項目規范開展及對一線人員的培養,負責項目經理的培養及帶教指導。
4、部門總監安排的其他事宜,如人員管理、技能培訓、文件審核、商務競標等等。
5、薪資架構:基本工資+績效+項目獎金+分紅,上不封頂。
任職要求:
1、醫學、藥學及相關專業本科及以上學歷,取得CFDA-GCP證書;
2、有3年以上CRO或藥企工作經驗,1-3個項目完整管理經驗,有global項目管理經驗者優先;
3、有良好的工作態度、溝通、協調、組織和執行能力;
4、能承受較大工作壓力,能激勵團隊協調合作,保質保量完成項目任務。
5、能適應短期出差。
篇3:臨床研究項目經理(APMPM)職位描述與崗位職責任職要求
職位描述:
工作職責
1.負責公司新藥臨床試驗的實施,監控臨床試驗過程,確保符合GCP要求;
2.負責與臨床研究者、CRO等合作方進行溝通和協調,推進臨床項目的進度;
3.參與制定臨床研究計劃與研究方案,對合作單位進行評估、篩選;
4.參與項目申報臨床相關資料的撰寫,協助注冊人員完成新藥申報工作;
5.負責藥物審評臨床相關信息的溝通和支持。
任職條件
1.臨床醫學、藥理學或生物學相關專業,本科以上學歷;
2.具有3-5年以上臨床研究經驗,其中3年以上抗腫瘤或糖尿病等新藥臨床研究項目管理經驗;
3.熟悉GCP以及SFDA新藥臨床試驗相關法律法規;
4.具有優秀的項目管理、專家溝通以及協調能力。