Lead Clinical Analyst (In-house Sr CRA)社

10K-15K/月

市辖区本科及以上

发布时间：2023-09-06

职位描述

职位描述：

LeadClinicalAnalyst(In-houseSrCRA)
 
职位描述：
 
协助不同国家的临床项目lead管理全球性或区域性大型临床试验，主要内容包括如下方面：
 
项目管理：协助临床项目lead进行trigger管理，质量把控，数据分析，风险评估，财务管理等
团队管理：负责对项目组中的临床试验分析员和临床实验分析助理进行日常管理
 
职位要求：
 
3-4年以上临床研究经验，以及LeadCRA或项目经理/项目经理助理等相关经验半年以上。
良好的英语口语能力，或掌握第二们外语(韩语或日语)
良好的沟通能力

PURPOSE
Applyclinicalresearchexpertisetoprovideprojectrelatedassistanceacrosscomplexandmultipleproject(s),sitesandprojectteams.Leadteamsfunctionally,whereassigned,includingawarenessofscopeofwork,budget,andresources.EnsureallworkisconductedinaccordancewithSOPs,policiesandpractices,goodclinicalpracticesandapplicableregulatoryrequirementsandmeetsqualityandtimelinemetrics.Mentor/coachClinicalProcessAssociate/Specialistcolleagues. 

RESPONSIBILITIES
Performcomplexprocessesandtasksthateventuallyresultinhighqualitydeliverablesthatarecompletedaccordingtoservicelevelagreements(SLAs)andwithinprojecttimelines   
Establishandmaintaineffectiveproject/sitecommunications    
Createandmaintainrelevantprojectdocuments/trackers 
Ensureaccuratecompletionandmaintenanceofinternalsystems,databases,trackingtools,timelinesandprojectplanswithprojectspecificinformation
Review,evaluateandrecommendmodificationstodesignatedprocesses
Overseeandparticipateindocumentmanagement(creation,review,maintenance,storage,asapplicable)
Participatein(study)teammeetingsandimplementactionitems
Collaboratewiththeprojectlead/teammembersincreation/reviewofstudydocumentsincludingQualitymanuals
Actaspointofcontactforassigneddeliverablesforspecificcustomersorprojects
Evaluatethequalityandintegrityofstudysitepracticesrelatedtotheproperconductoftheprotocolandadherencetoapplicableregulations.
Escalatequalityissuestorelevantstakeholdersand/orlinemanager.
Coachjuniorclinicalprocessassociate/specialists
 
REQUIREDKNOWLEDGE,SKILLSANDABILITIES
Advancedknowledgeofclinicaltrialconduct,andskillinapplyingapplicableclinicalresearchregulatoryrequirements;i.e.,ICHGCPandrelevantlocallaws,regulationsandguidelines,towardsclinicaltrialconduct.Familiaritywithrelatedsystemsandsoftware’sutilizedinclinicaloperations. 
StrongwrittenandverbalcommunicationskillsincludinggoodcommandofEnglishlanguage              
Resultsanddetail-orientedapproachtoworkdeliveryandoutput   
Goodproblemsolvingkills 
Goodplanning,timemanagementandprioritizationskills  
Abilitytohandleconflictingpriorities 
Attentiontodetailandaccuracyinwork   
Goodsoftwareandcomputerskills,includingMSOfficeapplicationsincludingbutnotlimitedtoMicrosoftWord,ExcelandPowerPoint 
Abilitytoestablishandmaintaineffectiveworkingrelationshipswithcoworkers,managersandclients.
Strongleadershipskills    
Abilitytoworkacrossculturesandgeographieswithahighawarenessandunderstandingof culturaldifferences   
ActasamentorforClinicalProcessAssociatecolleagues
MINIMUMREQUIREDEDUCATIONANDEXPERIENCE
Bachelor'sdegreeinlifesciencesorrelatedfieldandmin4yearswithrelevantclinicalresearchexperience;orequivalentcombinationofeducation,trainingandexperience

其他要求

招聘人数：1人
职能类别：临床协调员CRC

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。