Clinical Research Manager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：

OverallJobPurpose:

TheClinicalResearchManager(CRM)isresponsibleforallactivitiesrelatedtotheprojectplanning,conductingandcompletionwithintheirassignedterritory.The(A)CRMisresponsibleforhiring,trainingandassigningCRAsandCTAs,managingtheirperformance,ensuringtheircompliancewithICH-GCPandlocalregulations.

1.KeyAccountabilities

1.1LineManagement
·Identify,hireandsuperviseCRAsandCTAsandallocatetaskstothem.
·Provideeffectivelinemanagement,motivation,coachingandtrainingtoCRAsand
CTAstoimproveandmaintaintheirindividualperformance.
·Establishastrongcultureofopencommunication,honesty,andcreatean
environmentoftransparency,withtimeforreflectionandcontinuousimprovement.
·ImplementaneffectivetrainingprogrammetotrainnewCRAsandCTAsonSOPsand
relevantgovernmentregulations.
·SetannualobjectivesforallCRAsandCTAswithsupportingshort-termand
mid/longtermpersonalizeddevelopmentplans.
·AtleastannuallyassesstheperformanceofCRAsandCTAs.
·EnsureallCRAsandCTAsarekeptinformedofterritoryperformanceand
SOPs/policieschanges.
·Ensureapositive“customerservice”focusatalltimes.
·ManageanddirectCRAswithproblemsolvingatthesitelevelwhereneeded.

1.2ProjectManagement

·EnsureefficientimplementationandmaintenanceofSOPsandPoliciesin
compliancewithICH-GCP,LocalRegulationsandotherapplicablelawsand
guidelines.
·Supportinthedevelopmentandmaintenanceofprojectplans,budgets,schedules,
milestonesandtimelines.
·Establishandmaintainprojecttrackingandmanagementtool.
·Proactivelyidentifyissuesandkeepbothclientandinternalprojectsontrack
andonbudget.

1.3RelationshipManagement

·BeresponsibleforcreatingandmaintainingastrongandharmoniousCRAandCTA
teamspirittoensuresuccessfuldeliveryofkeybusinessobjectives/
initiatives.
·Establishandmaintaineffectiveworkingrelationshipswiththeotherdepartments
asappropriate.
·Supportintheidentificationandbuildingofnewrelationships,andfurther
developmentofexistingrelationshipswithexternalpersonnel,includingbutnot
limitedto:
ØPersonnelfromclientcompanies/potentialclientcompanies.
ØInvestigatorsandsitestaff.
ØOtherinstitutionalstaff.
ØRelevanthealthcareprofessionals.
·Supportinthedevelopmentofworkingrelationshipswithregulatoryauthority
andIRB/IECpersonnelwithintheconstraintsofanylocalguidelinesand
regulations.

1.4BusinessDevelopment

·Inputintothelocalandregionalbusinessdevelopmentstrategyandwillbe
responsibleforthemaintenanceoftheirlocalcomponentofaglobalbusiness
developmentdatabase.

2.JobRequirements

2.1Skills
·Excellentinterpersonal,verbalandwrittencommunicationskills.
·VerygoodworkingknowledgeofrelevantsoftwaresuchasMS-office(Excel,Word
andPowerPoint,etc).
·Strongorganizationalskillswithattentiontodetails.
·Strongleadershipskills.
·Excellentorganizationalandproblemsolvingskills.
·Strategic-thinkinganddecision-makingskill.
·Effectivetimemanagementskillsandabilitytomanagecompetingpriorities.
·Strongpeoplemanagementskills.
·Strongconflictmanagementskills.
·Abilitytomanagemultipleandvariedtasks.
Clientfocusedapproachtowork.
·Abletotravelwhenrequired.

2.2Education
·Bachelordegreeoraboveinmedical,nursing,pharmaceuticalorotherbio-
sciencerelatedarea.

2.3LanguageSkills
·ProficientwrittenandoralskillsbothinlocallanguageandEnglish.

2.4MinimumWorkExperience
Atleast5yearsofclinicalresearchexperiencewithatleast3yearsof
experienceinaleadershipcapacityinpharmaceuticalcompaniesorCRO.
Provenexcellentsitemanagementexperiencewithdemonstratedcapabilityto
solveproblemsandmediatecomplexcomplianceissues.
·Experiencedinclinicaltrialmanagementandpeoplemanagement.
·ExpertknowledgeofICH-GCPandlocalregulatoryrequirements.

其他要求

招聘人数：1人
职能类别：临床协调员CRC

公司介绍

BeijingHealthTechMedicalGroup(HT-Med)wasfoundedsince2004.WeareacomprehensivemedicalOperationanddevelopmentorganization.Assembleexcellenttalentsofmedicine,pharmacy,datamanagementandstatisticalfields,offeringprofessionalservicestosupportbiotechandpharmaceuticalcompaniesateverystageofproductlifecycle.

WeprovideMedicaltranslation,DataManagement,StatisticalAnalysis,MedicalWriting,RegulatoryAffairs,ProjectEvaluationandManagement,IndependentAudit,Training,CRA/CRC/DMdispatch.Sinceweestablished,weweredevelopingnewdrugswithChineseAcademyofMedicalSciences,PekingUniversityHealthScienceCenter,TheGeneralHospitalofthePLA,MilitaryMedicalSciences,etc.Hascooperatedwithover90%clinicaltrialsites(hospital)approvedbySFDA.

WedevelopedindependentlyEDC+CTMSbyourselves,obtained3patentsand2brands.BasingonexcellentITcapability,wedevelopProductsDataCenterforourclients,andcreatedroleexchangepatternbetweenCRAandCRC,improvedspeed&qualityofClinicalStudybythemodelofEDC+CRC,especiallyinPMS.Wehavebeenbecamethevendoroflotsofglobalcompany(AZ,GSK,BI,Abbott,Roch,Mundipharma,QPSetc.)andsomeofficialInstitution(ChineseAcademyofMedicalSciences,Pekinguniversity,ThegeneralhospitalofChinesePLA,Sanminghospital,Zhejiangoncologyhospital,AcademyofMilitaryMedicalSciencesoftheChinesePLAetc.).

WearefamiliarwithChinaSFDApolicyandCDEmentality,possessingmassofexpertresourceandmarketingsupport.wecouldcover90%Chinesecertificatedclinicalresearchhospitalbylotsofhome-basedemployeein18cities.

公司邮箱：ling.zhang@ht-med.com
公司网址：http://www.ht-med.com