高级医学经理/副总监

面议

广州市博士及以上

刷新时间：2024-04-01

职位描述

AssociateDirector/Sr.MedicalManager,isresponsibleforthedevelopmentandexecutionofclinicaltrials,includingbutnotlimittoauthoringkeystudydocuments(e.g.,protocol,studycharters,memostosites),andmonitoringandreviewingclinicaltrialdata.Whoalsoshallworkwithmultiplefunctionstoensurethesuccessfulcompletionoftheclinicaltrialwithinfullcompliancewithglobalregulations.

ResponsibilitiesandDuties

CollaboratewithClinicalOperations,RegulatoryAffairs,Biostatistics,ClinicalPharmacology,andotherrelevantfunctionstodesignandexecuteclinicaltrials.

WorkincollaborationwithourRegulatoryandSafetyteamstoensureIND,protocol,ICFandotherstudyandregulatorydocumentsandreportingrequirementsarefulfilled.

WorkincollaborationwithClinicalOperationsandStudyManagementTeam(SMT)toassistinvendorselectionandsiteselection,initiation,andongoingmedicalmonitoring.

Worktohelpresolveanykeyissuesthatmayariseduringclinicalstudies.

Helpidentifykeyopinionleadersfortargetindications,interactwithPI.andhelporganizeandpreparescientificadvisoryboardsasneeded.

Serveasaninternalclinicalexpertandparticipateinglobaldevelopmentactivitiesandmeetingsasamedicalsubjectmatterexpert.

Qualifications:

Minimumof2-3yearsofclinicalpracticeexperience

Subspecialtyboardeligibility/certificationinEndocrinology,Orthopedicscardiovascularorimmunologypreferred.

Priorexperienceauthoring,monitoring,analyzing,andpresentingclinicaltrialrelateddocumentssuchasstudyconceptdocuments,clinicaltrialprotocols,investigationalbrochures.

Strongbasicscienceorclinicalresearchbackgroundinacademiaorbiopharmaindustryworkexperience.

KnowledgeofGCP,ICH,EMA/CHMP,andFDApolicies

Excellentoralandwrittencommunicationskills.ProficiencyinEnglishisaplus.

Strongabilitytoworkunderpressuretoensuremovingaheadprojectssmoothly.

Previousexperienceinclinicaltrialsandregulatoryfilings

Demonstratedabilitytostayintrendswiththelatestinformationintheprofession.

Stronginterpersonalskillsandproblem-solvingabilities

Keensenseofresponsibilityandteamworkspirit,abletocooperatewithcolleaguesfromaroundtheworld.

其他要求

招聘人数：1人
职能类别：其他医疗管理

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。