临床研究项目经理PMclinicalprojectmanager
面议
市辖区
刷新时间:2022-03-30
职位描述
KeyResponsibilities:
·ToparticipateintheselectionofCROandotherexternalvendorsandtakeresponsibilityforensuringthatCROs/vendorsdeliverinaccordancewiththespecification,qualitystandardandtimeframesetandmanageCRO/CRArelationshipasrequired.
·Totakeresponsibilityforpreparingdetailedtimelinesandestablishingclinicalstudies’milestonesforassignedprojects,ensuringtheyareperformedtothemostrigorousstandardsofqualityandtimelydelivery;identifyandgainapprovalforhighqualityinvestigatorsandstudysitesfortheconductofclinicalstudiesinconjunctionwithmedicalsciences;ensurethatthenecessaryregulatory,safetyanddataevaluationrequirementsaremettoallowtheconductofclinicalrelatedactivitiesinconjunctionwiththeRegulatory,PharmacovigilanceandDataManagementfunctions.ToensurethatanyimportantsafetyissuesarediscussedwithMedicalSciencesandlinemanagement.
·Tomanagethefinanceaspectofstudiestoensuretheyareconductedwithinbudget
·Tooverseeregularnewsletterpreparationthatinformsandmotivatesinvestigatorstodelivertotimelinesandquality;prepareand/ormanagetheproductionofalldocumentsnecessarytoimplementandmonitorthestudyinaprofessional,highqualityandtimelymanner;reviewandrecommendamendmentstothestudyprotocolstoensurethestudyfeasibilityandtosubsequentlyplanandorganizeworkschedules.
·Tocontributeproactivelytotheefficientoperationoftheclinicaldevelopmentactivitiesandtosystemsandprocessesbeingplannedandimplemented;participateinthepreparation,review,updatingandtrainingofSOPs;developtherelevantSOPsforthefunctionofClinicalOperations.
Requirements:
·Bachelordegreeoraboveoflifescienceormedicalgraduateorotherrelevantqualifications,with5-8years’experienceandproventrackrecordinthejobfunction
·Substantialrelevantexperienceofpharmaceuticaldrugdevelopmentincludingprojectmanagementofnationalandinternationalprograms.
·IntimateknowledgeofGoodClinicalPractice(GCP).
·Experienceofpreparingclinicalstudydocumentation.
·Anunderstandingofthedrugdevelopmentprocess.
·Experienceofcompilingandmanagingclinicalstudybudgets.
·Thoroughknowledgeofclinicalresearchconcepts,practices,andICHGuidelinesregardingdrugdevelopmentphases,clinicalresearchanddatamanagementmethods.
·ExcellentwrittenandverbalcommunicationskillsinbothChineseandEnglish.
·ExperienceofmanaginganddevelopingrelationshipswithContractResearchOrganizations(CROs).
·Excellentorganizationalandmanagementskills.
·Goodleadershipskillsandcaninspiringotherpeople.
其他要求
-
1人
- 临床协调员CRC
公司介绍
诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业,总部位于杭州,下属有上海、南京、广州、武汉等多家分公司,同时自主开发国内领先的猎头办公系统及医药人才网站,全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台,在欧、美、日等国家建立了海归引进平台,同时积极开展医药高等院校公益系列讲座,搭建了以人力、企业为主体的立体化咨询服务网,为医药企业人才队伍建设发挥了积极重要作用,为很多医药企业解决了高端人力之困。
- 所在城市:
- 所任职位:
- 分公司总
企业信息
- 名称:
- 某医药研发公司
- 行业:
- 制药.生物
- 性质:
- 私营/民营企业
- 规模:
- 50-99人
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