AsaeConsentProductTechLead,youwillbekeymemberoftheClinicalDevelopmentPlatformcapabilityITteammanagingClinicaleSourcetechnologiesandsolutionssuchasEHR,eCOA/ePRO,LabsbuiltonproductssuchasEDC,IXRStoensuredataiscapture,transform,andpublishinadherencetoCDISCstandardsandrisk-basedstudymonitoringapproach.
Your roleInthisroleonewillhavetheopportunitytocollaboratewithBusinessPlatformManager,ProductManager/Owner,ITPlatformEngineers,DevOpsLead,andSolution/IntegrationArchitectswithinAZtoestablishbestpracticesforsoftwaredevelopmentandengineering,businessanalysis,solutiondesigns,enterprisesoftwareintegrationandprojectmanagementinlinewithBizDevOpsResponsibilitiesmayincludecollaborationwithTechvendorsandinternalstakeholderstodefinetechnicalrequirementsanddevelopfunctionalandintegrationimplementationplansaroundexternalclinicaldataacquisitionintoEDCorDataManagementReviewapplicationsuchasVeeva,MedidataorSignantServeasTechnicalSubjectMatterExpert(SME)forClinicalDataacquisitionsolutionsthroughtheimplementationprocessandlifecycleofthestudybyprovidingguidancetothepartner/sponsorandinternalteamsonthedesignandsupportofClinicalDataProducts.Coordinatetechnicalbacklogs/Story/EpicinJIRA(asappropriate)andensureITdeliverybasedontheproductdeliveryroadmappriorityinAgileWoWs."Your skills and experienceBachelor’s/Master’sdegreeinIToralifescience-relateddisciplinewithexperienceinIT,CRO,orPharma.Excellentunderstandingofcommonindustry-standardbusinesspracticesrelatedtoclinicaltrialsdesignandconductincluding(studysetup,clinicaloperations,datamanagement,andreporting).ClinicalRegulatoryDataStandardsExpertise:WorkingknowledgeofCDASH,SDTM,andCDISCcontrolledterminologyinthecontextofclinicaldataandFHIRElectronicHealthRecords.StrongknowledgeofICHguidelines,21CFRPart11,clinicaltrialmethodology,andsoftwaredevelopmentlifecycleactivities.ExperiencewithexternalvendorsandCROstosupportstandardsorEDCintegrationswiththird-partyplatforms(e.g.,CentralLab,ePRO,IRT,DataReview/Monitoring).ProventrackrecordofsuccessfullyimplementingeSourcetechnologies,suchasElectronicDataCapture(EDC)systems,IXRS,electronicClinicalOutcomeAssessment(eCOA)platforms,andelectronicPatient-ReportedOutcome(ePRO)solutions.TechnicalEngineeringFull-StackDevelopmentExpertise:Strongunderstandingoffull-stackwebapplicationdevelopment,coveringfront-end,back-end,anddatabaselayers.Proficiencyinmodernfront-endframeworks(e.g.,React,Angular,orVue.js)andback-endtechnologies(e.g.,Node.js,Python,Java,or.NET).Experienceinmicroservicesarchitectureforscalableandmodularapplications,includingAPI-drivendevelopmentusingRESTfulandGraphQLservices.Hands-onexperiencewithcloud-basedplatforms(AWS,Azure,orGCP)fordeployingandmanagingwebapplications.Understandingofcontainerization(Docker,Kubernetes)andDevOpspractices(CI/CD,InfrastructureasCode).Experienceinimplementingdataandcontentorchestrationlayers,ensuringseamlessintegrationandinteroperabilitybetweeninternalandexternalsystems.StrongknowledgeofAPIdevelopment,integrationpatterns,andsecuritybestpractices(OAuth,JWT,OpenIDConnect)forconnectingwithexternalapplicationsandthird-partyplatforms.Proficiencyinprogramminglanguages(e.g.,SQL,Python,JavaScript,Java)withafocusondatamodeling,transformation,andanalytics.Hands-onexperiencewithdatastreamingandETLpipelinesusingtoolslikeApacheKafka,Airflow,SnapLogic,MuleSoftorsimilarframeworks.FamiliaritywithNoSQLandrelationaldatabases(PostgreSQL,MongoDB,MySQL)forefficientdatamanagementandretrieval.Excellentcommunicationskills,withtheabilitytocollaborateeffectivelywithstakeholdersatalllevels.Strongcollaborativeskillswithademonstratedabilitytoleadcross-functionalteamsanddriveprojectstosuccessfulcompletion.ExperienceinAgiledevelopmentmethodologies(Scrum,SAFe)formanagingtechnology-drivenprojectsinclinicalandregulatoryenvironments.AccreditedCertificationsfromSCDM/ACDMoranyvendoroffereddatamanagementtrainings.Experience with cloud-based platforms (e.g., Veeva, Salesforce, Oracle Clinical, AWS, Azure) and knowledge of security best practices in healthcare IT environmentsEDCbuild(Rave)/Informandgloballibrarymaintenancesupportexperienceaplus.ExtensiveExperienceinclinicaldatamanagement,clinicaldataanalyticsandvisualization.clinicaldataprogrammingexperienceisaplusLife at CapgeminiCapgeminisupportsallaspectsofyourwell-beingthroughoutthechangingstagesofyourlifeandcareer.Foreligibleemployees,weoffer:
FlexibleworkHealthcareincludingdental,vision,mentalhealth,andwell-beingprogramsFinancialwell-beingprogramssuchas401(k)andEmployeeShareOwnershipPlanPaidtimeoffandpaidholidaysPaidparentalleaveFamilybuildingbenefitslikeadoptionassistance,surrogacy,andcryopreservationSocialwell-beingbenefitslikesubsidizedback-upchild/eldercareandtutoringMentoring,coachingandlearningprogramsEmployeeResourceGroupsDisasterReliefAbout CapgeminiCapgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55 year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to
engineering,allfueledbyitsmarketleadingcapabilitiesinAI,generativeAI,cloudanddata,combinedwithitsdeepindustryexpertiseandpartnerecosystem.TheGroupreported2024globalrevenuesof€22.1billion.
Get the future you want |www.capgemini.com
DisclaimerCapgeminiisanEqualOpportunityEmployerencouragingdiversityintheworkplace.Allqualifiedapplicantswillreceiveconsiderationforemploymentwithoutregardtorace,nationalorigin,genderidentity/expression,age,religion,disability,sexualorientation,genetics,veteranstatus,maritalstatusoranyothercharacteristicprotectedbylaw.
ThisisageneraldescriptionoftheDuties,ResponsibilitiesandQualificationsrequiredforthisposition.Physical,mental,sensoryorenvironmentaldemandsmaybereferencedinanattempttocommunicatethemannerinwhichthispositiontraditionallyisperformed.Whenevernecessarytoprovideindividualswithdisabilitiesanequalemploymentopportunity,Capgeminiwillconsiderreasonableaccommodationsthatmightinvolvevaryingjobrequirementsand/orchangingthewaythisjobisperformed,providedthatsuchaccommodationsdonotposeanunduehardship.
Capgeminiiscommittedtoprovidingreasonableaccommodationsduringourrecruitmentprocess.Ifyouneedassistanceoraccommodation,pleasereachouttoyourrecruitingcontact.
PleasebeawarethatCapgeminimaycaptureyourimage(videoorscreenshot)duringtheinterviewprocessandthatimagemaybeusedforverification,includingduringthehiringandonboardingprocess.
ClickthefollowinglinkformoreinformationonyourrightsasanApplicanthttp://www.capgemini.com/resources/equal-employment-opportunity-is-the-law
ApplicantsforemploymentintheUSmusthavevalidworkauthorizationthatdoesnotnowand/orwillnotinthefuturerequiresponsorshipofavisaforemploymentauthorizationintheUSbyCapgemini.
Aboutthejobyou’reconsideringAsaeConsentProductTechLead,youwillbekeymemberoftheClinicalDevelopmentPlatformcapabilityITteammanagingClinicaleSourcetechnologiesandsolutionssuchasEHR,eCOA/ePRO,LabsbuiltonproductssuchasEDC,IXRStoensuredataiscapture,transform,andpublishinadherencetoCDISCstandardsandrisk-basedstudymonitoringapproach.
Your roleInthisroleonewillhavetheopportunitytocollaboratewithBusinessPlatformManager,ProductManager/Owner,ITPlatformEngineers,DevOpsLead,andSolution/IntegrationArchitectswithinAZtoestablishbestpracticesforsoftwaredevelopmentandengineering,businessanalysis,solutiondesigns,enterprisesoftwareintegrationandprojectmanagementinlinewithBizDevOpsResponsibilitiesmayincludecollaborationwithTechvendorsandinternalstakeholderstodefinetechnicalrequirementsanddevelopfunctionalandintegrationimplementationplansaroundexternalclinicaldataacquisitionintoEDCorDataManagementReviewapplicationsuchasVeeva,MedidataorSignantServeasTechnicalSubjectMatterExpert(SME)forClinicalDataacquisitionsolutionsthroughtheimplementationprocessandlifecycleofthestudybyprovidingguidancetothepartner/sponsorandinternalteamsonthedesignandsupportofClinicalDataProducts.Coordinatetechnicalbacklogs/Story/EpicinJIRA(asappropriate)andensureITdeliverybasedontheproductdeliveryroadmappriorityinAgileWoWs."Your skills and experienceBachelor’s/Master’sdegreeinIToralifescience-relateddisciplinewithexperienceinIT,CRO,orPharma.Excellentunderstandingofcommonindustry-standardbusinesspracticesrelatedtoclinicaltrialsdesignandconductincluding(studysetup,clinicaloperations,datamanagement,andreporting).ClinicalRegulatoryDataStandardsExpertise:WorkingknowledgeofCDASH,SDTM,andCDISCcontrolledterminologyinthecontextofclinicaldataandFHIRElectronicHealthRecords.StrongknowledgeofICHguidelines,21CFRPart11,clinicaltrialmethodology,andsoftwaredevelopmentlifecycleactivities.ExperiencewithexternalvendorsandCROstosupportstandardsorEDCintegrationswiththird-partyplatforms(e.g.,CentralLab,ePRO,IRT,DataReview/Monitoring).ProventrackrecordofsuccessfullyimplementingeSourcetechnologies,suchasElectronicDataCapture(EDC)systems,IXRS,electronicClinicalOutcomeAssessment(eCOA)platforms,andelectronicPatient-ReportedOutcome(ePRO)solutions.TechnicalEngineeringFull-StackDevelopmentExpertise:Strongunderstandingoffull-stackwebapplicationdevelopment,coveringfront-end,back-end,anddatabaselayers.Proficiencyinmodernfront-endframeworks(e.g.,React,Angular,orVue.js)andback-endtechnologies(e.g.,Node.js,Python,Java,or.NET).Experienceinmicroservicesarchitectureforscalableandmodularapplications,includingAPI-drivendevelopmentusingRESTfulandGraphQLservices.Hands-onexperiencewithcloud-basedplatforms(AWS,Azure,orGCP)fordeployingandmanagingwebapplications.Understandingofcontainerization(Docker,Kubernetes)andDevOpspractices(CI/CD,InfrastructureasCode).Experienceinimplementingdataandcontentorchestrationlayers,ensuringseamlessintegrationandinteroperabilitybetweeninternalandexternalsystems.StrongknowledgeofAPIdevelopment,integrationpatterns,andsecuritybestpractices(OAuth,JWT,OpenIDConnect)forconnectingwithexternalapplicationsandthird-partyplatforms.Proficiencyinprogramminglanguages(e.g.,SQL,Python,JavaScript,Java)withafocusondatamodeling,transformation,andanalytics.Hands-onexperiencewithdatastreamingandETLpipelinesusingtoolslikeApacheKafka,Airflow,SnapLogic,MuleSoftorsimilarframeworks.FamiliaritywithNoSQLandrelationaldatabases(PostgreSQL,MongoDB,MySQL)forefficientdatamanagementandretrieval.Excellentcommunicationskills,withtheabilitytocollaborateeffectivelywithstakeholdersatalllevels.Strongcollaborativeskillswithademonstratedabilitytoleadcross-functionalteamsanddriveprojectstosuccessfulcompletion.ExperienceinAgiledevelopmentmethodologies(Scrum,SAFe)formanagingtechnology-drivenprojectsinclinicalandregulatoryenvironments.AccreditedCertificationsfromSCDM/ACDMoranyvendoroffereddatamanagementtrainings.Experience with cloud-based platforms (e.g., Veeva, Salesforce, Oracle Clinical, AWS, Azure) and knowledge of security best practices in healthcare IT environmentsEDCbuild(Rave)/Informandgloballibrarymaintenancesupportexperienceaplus.ExtensiveExperienceinclinicaldatamanagement,clinicaldataanalyticsandvisualization.clinicaldataprogrammingexperienceisaplusLife at CapgeminiCapgeminisupportsallaspectsofyourwell-beingthroughoutthechangingstagesofyourlifeandcareer.Foreligibleemployees,weoffer:
FlexibleworkHealthcareincludingdental,vision,mentalhealth,andwell-beingprogramsFinancialwell-beingprogramssuchas401(k)andEmployeeShareOwnershipPlanPaidtimeoffandpaidholidaysPaidparentalleaveFamilybuildingbenefitslikeadoptionassistance,surrogacy,andcryopreservationSocialwell-beingbenefitslikesubsidizedback-upchild/eldercareandtutoringMentoring,coachingandlearningprogramsEmployeeResourceGroupsDisasterReliefAbout CapgeminiCapgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55 year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to
engineering,allfueledbyitsmarketleadingcapabilitiesinAI,generativeAI,cloudanddata,combinedwithitsdeepindustryexpertiseandpartnerecosystem.TheGroupreported2024globalrevenuesof€22.1billion.
Get the future you want |www.capgemini.com
DisclaimerCapgeminiisanEqualOpportunityEmployerencouragingdiversityintheworkplace.Allqualifiedapplicantswillreceiveconsiderationforemploymentwithoutregardtorace,nationalorigin,genderidentity/expression,age,religion,disability,sexualorientation,genetics,veteranstatus,maritalstatusoranyothercharacteristicprotectedbylaw.
ThisisageneraldescriptionoftheDuties,ResponsibilitiesandQualificationsrequiredforthisposition.Physical,mental,sensoryorenvironmentaldemandsmaybereferencedinanattempttocommunicatethemannerinwhichthispositiontraditionallyisperformed.Whenevernecessarytoprovideindividualswithdisabilitiesanequalemploymentopportunity,Capgeminiwillconsiderreasonableaccommodationsthatmightinvolvevaryingjobrequirementsand/orchangingthewaythisjobisperformed,providedthatsuchaccommodationsdonotposeanunduehardship.
Capgeminiiscommittedtoprovidingreasonableaccommodationsduringourrecruitmentprocess.Ifyouneedassistanceoraccommodation,pleasereachouttoyourrecruitingcontact.
PleasebeawarethatCapgeminimaycaptureyourimage(videoorscreenshot)duringtheinterviewprocessandthatimagemaybeusedforverification,includingduringthehiringandonboardingprocess.
ClickthefollowinglinkformoreinformationonyourrightsasanApplicanthttp://www.capgemini.com/resources/equal-employment-opportunity-is-the-law
ApplicantsforemploymentintheUSmusthavevalidworkauthorizationthatdoesnotnowand/orwillnotinthefuturerequiresponsorshipofavisaforemploymentauthorizationintheUSbyCapgemini.
Capgemini discloses salary range information in compliance with state and local pay transparency obligations. The disclosed range represents the lowest to highest salary we, in good faith, believe we would pay for this role at the time of this posting, although we may ultimately pay more or less than the disclosed range, and the range may be modified in the future. The disclosed range takes into account the wide range of factors that are considered in making compensation decisions including, but not limited to, geographic location, relevant education, qualifications, certifications, experience, skills, seniority, performance, sales or revenue-based metrics, and business or organizational needs. At Capgemini, it is not typical for an individual to be hired at or near the top of the range for their role. The base salary range for the tagged location is [$86,900 - $149,240]. This role may be eligible for other compensation including variable compensation, bonus, or commission. Full time regular employees are eligible for paid time off, medical/dental/vision insurance, 401(k), and any other benefits to eligible employees. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, or any other form of compensation that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.