临床项目经理/高级临床项目经理 CPM社

20K-30K/月

市辖区本科及以上

发布时间：2023-09-06

职位描述

职位描述：

ZaiLabseeksindividualswhohavetheclinicaltrialmanagementexpertisetomanageallaspectsofclinicalstudiesincompliancewithallapplicabledomesticandinternationalregulations,guidelines,andcompanystandards,includingimplementationofclinicalplan,monitoring,managementandanalysisofclinicaldata,andaddressingissuesthatariseduringtheclinicaltrial.
Responsibilities:

Plansandexecutestriallevelprojectmanagementactivitiesforassignedstudiesincludingtrialleveltimelines,riskassessment,mitigationplans,andotheraspectsoftriallevelprojectmanagement(e.g.budget,metrics).Leadsstudyteammeetings.
Developsandtracksoveralltrialtimelineandgainsalignmentwithaffiliatesandteammembersonmilestonedates.
Ensuresdatacomplianceatthetrialleveltoachievecountryandsitelevelcompliance,asappropriate.
Managesrelationshipsandservesasthefocalpointofcommunicationbetweeninternalandexternalclinicalresearchpartneratthetriallevel.
Productivelyidentifiesandcommunicatesappropriatelythestatusofongoingprojects,Issues,andrisksthatmayaffectthecriticalpathoftheclinicaltrialandprojectschedule.
Reviewssourcingalternatives,providesnecessarystudyspecificactionsinordertoobtainreliablestudycosts,staffingstrategy,andtimelineprojections.
ProvidesoversightofCROperformancethroughoutstudyimplementation.
Developsstudytrainingandmayalsocoordinate/delivertraining,asappropriate.
Obtainsclinicaltrialcostforecasts.Establishesandmonitorsthetrialbudget.
Managesandtrackstrialenrollment.
Coordinatesproposalreviewswiththirdpartyvendors,andprovidesinputregardingneededchangesincontractconditions.
Anticipates,manages,andescalatesIssuesasappropriate.
Maintainsandarchivesattrialleveldocumentation.
Partnerswithstudyteaminthemanagementofdatalocks(finalandinterim)andsiteclosure.
Requirements
Bachelor'sdegreeinascientificorhealthrelatedfield.
5+yearsclinicalresearchorrelevantexperience,phaseIIIoncologytrialexperiencepreferred.
ComprehensiveunderstandingofGoodClinicalPractices,GoodDocumentationPractices,CFDAregulations.
Excellentinterpersonalskillsanddemonstratedbusinessacumenwithanabilitytointerfacesuccessfullywithphysiciansandtheirstaff,executivemanagement,andcross-functionalteamsandindividuals.
Excellentverbalandwrittencommunicationskills.
Excellentofficecomputerskills,includingexperiencewithclinicaldatabases.
Effectivecross-functionalteamplayerwithabilitytoworkinateamenvironment.
Demonstratedleadershipskills.
Excellentprojectmanagementandorganizationalskills;abletohandlemultipletasks/projectsandmanageprioritiesaccordingly;withahightoleranceforambiguity.Experiencedinservingonproductdevelopmentteamsandunderstandstheproductdevelopmentlifecycle.

其他要求

招聘人数：1人
职能类别：临床协调员CRC

公司介绍

ZAILabisaleadingbiotechcompanybasedinChinafocusedondiscoveringanddevelopinginnovativemedicinesforunmetmedicalneedsglobally.Thecompanyisbuildingastrongportfoliooftherapeuticprogramsaimedattransformingpatients’lives.ZaiLabhasaworldclassleadershipteamwithdeepexperienceatglobalpharmaceuticalandbiotechorganizations.Theteamhasastrongtrackrecordofsuccess–successfullytakenfivenoveldrugcandidatesintoclinicaltrialsinChina,pioneerednewregulatorychannels,securedregulatoryapprovalsinrecordtimes,conductedmultipleINDtrialsintheUS,andbroughtthefirstChinadiscovereddrugintoGlobalPhaseIIItrials.ZaiLabiscommittedtobuildagloballyleadingdrugresearchanddevelopmentpowerhousewithacultureofexcellenceandteamworkandastrongfocusonfosteringinnovationandcreativity.

Formoreinformation,pleasevisitwww.zailaboratory.com.