Clinical Data Management Project Lead(SH or BJ)社

20K-30K/月

市辖区

发布时间：2023-09-06

职位描述

职位描述：

LocationcouldbeinBeijingorShanghai

PURPOSE
Manageend-to-enddeliveryofdatamanagementservicesforsingle/multi-serviceprojects,ensuringqualitydeliverablesontimeandwithinbudget,tocustomersatisfaction.ProvidecomprehensivedatamanagementexpertisetoClinicalDataManagement(CDM)teamtoprovidehighqualitydatamanagementproductsthatmeetcustomerneeds.Provideleadershipandvisiontotheteamintheareasofprojectplanning,execution,andclose-out;financialmanagement;communications;andmilestonedeliverables.MayperformroleofDataTeamLead(DTL),ProgramLead,and/oraleadershiproleinaspecificCDMtask(e.g.SubjectMatterExpert(SME).ComplywithGoodClinicalPractices(GCPs),applicableregulatoryguidelines,SOPs,policies,and,whereavailable,CDMguidancedocuments.
RESPONSIBILITIES
ClientManagement:
？Serveasprimarypointofcontactforcustomerondatamanagementdeliverables
？Provideprojectmanagementexpertiseworkingwithcustomerdatamanagers,keydecisionmakers,andinternalteammemberstomanagecontinuousprocessimprovements,issueescalation,workloadprojections,andprovidetechnicalexpertise
？Providejustificationforandperformdirectnegotiationswithcustomer,e.g.,timelines,financial,process,resources
？Maintainstrongcustomerrelationships
？EnsureopencommunicationswithcustomerandQuintilesmanagementtomanageandmeetcontractualobligations

ServiceManagement:
？MeetwithDataOperationsCoordinator(DOC)and/orDataOperationsteammembersonaregularbasistoensuremilestonesmeettimelinesandqualitydeliverables
？EstablishstrongcommunicationswithDataOperationsteam,functionalleads,projectmanagersandallotherstakeholders
？SupportDMservicedeliverywithcomprehensiveDMprocessandtechnicalexpertiseinexecutingprojects
？Serveastheescalationpointforunresolveddataissues;workwithclientdatamanagers,vendors,internalteammembersforresolution
？Workwithfunctionalmanager(s)toensureappropriateresourcesareassignedtomeetprojectdeliverables
？Createand/orreviewandsign-offonalldatamanagementplan(DMP)documents
？EnsureserviceandqualitymeetagreeduponspecificationspertheDMPandcontract/SOW
？Implementproactivequalitymanagementplansacrossmultipleprojects/programme.Trackserviceperformanceandprovideleadershiptoidentifyrootcausesofissuesandimplementremedialactions
？Continuouslylookforopportunitiestoimproveservice;workwithteamtodevelopandimplementplantore-organiseanddrivechangeacrossmultipleprojects/programme(withminimalsupport)
？Ensuretimelyfollow-upandresolutionofcomplianceissues
？ServeasSubjectMatterExpert(SME)
-ProvideleadershipandexpertiseinaspecificCDMtaskortechnology
？TrainandmentorjuniorDTLstaffinDMexpertise.MaycoordinatetheworkofmorejuniorDTLstaff
？Maintaininternaltrackingdatabasesandsystems

FinancialManagement/BusinessDevelopmentSupport:
？Ensureserviceandqualitymeetagreedupontimelinesanddeliverablesincontract/ScopeofWork(SOW)
？ManageSOW/budget
-Reviewfinancialreportsonamonthlybasisandparticipateinprojectreviewsasrequested
-Identifyoutofscopetasksandtrackchangeorderstocompletion
？ServeasProjectManagerforsingleserviceDMprojects,includingfinancialtracking,revenuerecognition,andinvoicing
ParticipateinandsupportRFPprocess(reviewRFPdocuments,pricing,attendbiddefense)
Other:
？IndependentlybringsolutionstotheCDMteam/CDMdepartment
？Leadand/orparticipateinafocusteamorglobalorlocalbestpracticeteam
？Communicatelessonslearnedand/orpresentinCDMworkshop(s)
？Participateinthedevelopmentandimplementationofnewtechnologyortool
？Presentatprofessionalconferencesand/orpublisharticlesinprofessionaljournals
？Providereviewandinputondeveloping,revising,andmaintainingcoreoperatingproceduresandworkinstructions
？Performotherdutiesasdirectedbythefunctionalmanager

REQUIREDKNOWLEDGE,SKILLSANDABILITIES
？PreviousexperienceandprovencompetenceinmanagingdeliveryofmultipleprojectsthroughfullDMlife-cycle(severalstudies/programmes)
？Demonstratedexpertdatamanagementskillsandthoroughknowledgeofthedatamanagementprocess(e.g.,therapeuticarea,extensiveknowledgeinDMprocesses,SAEreconciliation,externaldatavendorreconciliation,managementoflocallaboratorydata,and/ornewtechnology)
？Previousexperienceofhandlingcustomernegotiations
？KnowledgeofMedicalTerminology,Pharmacology,Anatomy,and/orPhysiology
？Knowledgeofoperatingproceduresandworkinstructionsandtheabilitytoapplytheminpractice
？KnowledgeofGoodClinicalPracticesandrelevantregulatoryguidelines
？Excellentcommunication,interpersonal,customerservice,andteamworkskills
？Excellentprojectmanagementskills
？Excellentorganizationalandproblem-solvingskills
？Abilitytoworkindependentlywithavailableresources,e.g.,functionalmanagers,seniorDTLs
？Comprehensiveunderstandingofclinicaldrugdevelopmentprocess
？Abilitytoestablishandmaintaineffectiveworkingrelationshipswithcoworkers,managersandcustomers

MINIMUMREQUIREDEDUCATIONANDEXPERIENCE
？Bachelor’sDegree,oreducationalequivalent,inhealth,clinical,biologicalormathematicalsciences,orrelatedfield,andaminimumof5yearsdirectDataManagementexperience,including3ormoreyearsasaCDMprojectlead;orequivalentcombinationofeducation,trainingandexperience

其他要求

招聘人数：1人
职能类别：数据库建设

公司介绍

昆泰公司简介

昆泰是全球最大的生物制药服务企业（2011年净收入超过30亿美元），并且是全球范围内唯一一家可以提供全方位的临床、商业、咨询及投资解决方案的生物制药服务企业。昆泰公司覆盖80个国家，拥有达2.7万名员工。