About this role
Technical Product Management role responsible for owning and continuously improving core clinical development systems. The focus is end-to-end study delivery, stable compliant operations (GxP/CSV), and seamless data/system integration in a cloud environment.
Key Responsibilities
- Own end-to-end lifecycle for core clinical development systems and roadmap through retirement
- Define product vision/strategy, set OKRs/KPIs, and manage demand intake/prioritization
- Drive continuous discovery and translate pain points into requirements/user stories
- Manage cross-system dependency management and end-to-end integration delivery including data reconciliation
- Lead release, validation/compliance planning, support readiness, and vendor coordination (cutover, hypercare)
Technical Overview
Owns lifecycle management for ~10 clinical development systems such as IRT/RTSM, EDC, CTMS, eTMF, PV database, statistics and analysis platform, Data Room, and eCOA/ePRO. Drives roadmap and integration delivery across systems to ensure coherent data flow from EDC through pharmacovigilance and analytics, while managing validation/compliance activities and cloud integration using AWS and AliCloud.
Ideal Candidate
The ideal candidate is a mid-level Technical Product Management professional who can own and improve end-to-end clinical development systems supporting study delivery. They have strong experience with GxP/CSV compliance, backlog/roadmap management, cross-system integrations (EDC through PV and analytics), and cloud deployment/integration in Amazon Web Services (AWS) and/or AliCloud environments.
Must-Have Skills
Own and continuously improve Innovation Collaboration Center core clinical development systems to support end-to-end study deliveryEnsure stable operations and compliant processes (GxP/CSV)Drive integrations in a cloud environment (AWS/AliCloud)Collaborate with Product team to own end-to-end lifecycle for core clinical development systems (IRT/RTSMEDCMedical ReviewCTMSeTMFPV databasestatistics & analysis platformData Roomproject management via Microsoft Power PlatformeCOA/ePROetc.)Define product visionstrategyand roadmap aligned to clinical development objectivescompliance requirementsand user experience; establish OKRs/KPIsLead demand intake and prioritization with business stakeholdersDrive continuous discovery and translate pain points into requirementsuser storiesand solution options (configurationintegrationautomationor process change)Maintain prioritized backlog and release plan; own cross-system dependency management and end-to-end integration delivery to ensure coherent data movement from EDC through PV and analytics consumptionLead releasevalidation/complianceand support planning (GxP considerationsvendor coordinationcutoverhypercare)Manage product financials and vendor contracts where applicable
Tools & Platforms
Amazon Web Services (AWS)AliCloudMicrosoft Power PlatformEDC (Electronic Data Capture)eTMF (electronic Trial Master File)CTMS (Clinical Trial Management System)PV databaseeCOA (electronic Clinical Outcome Assessment)ePRO (electronic Patient-Reported Outcome)IRT/RTSM (Interactive Response Technology / Randomization and Trial Supply Management)
Required Skills
technical product managementproduct vision and roadmapOKRsKPIsdemand intake and prioritizationclinical R&D processesGxP/CSV compliancedata integrationAWSAliCloudEDCCTMSeTMFPV databaseMicrosoft Power Platformbacklog managementrelease planningvalidation and compliancechange managementvendor coordinationcutoverhypercaredata reconciliationintegration delivery
Hard Skills
product lifecycle managementclinical development systemsend-to-end study deliveryGxP (Good Practice)CSV (Computer System Validation)data/system integrationcloud environmentAmazon Web Services (AWS)AliCloudclinical R&D processesprotocol to database locksafety reportingclinical data review and analysis readinessdecentralized trialsreal-time data reviewautomationanalytics enablementOKRs (Objectives and Key Results)KPIs (Key Performance Indicators)demand intake and prioritizationdata integritypatient safetytotal cost of ownership (TCO)system performance/availabilitycycle timerelease success ratevalidation/compliance statusincident/defect trendsbacklog managementrelease planningcross-system dependency managementinterfacesdata flowreconciliationEDC (Electronic Data Capture)PV database (Pharmacovigilance database)statistics and analysis platformeTMF (electronic Trial Master File)CTMS (Clinical Trial Management System)IRT/RTSM (Interactive Response Technology / Randomization and Trial Supply Management)Medical ReviewData RoomeCOA (electronic Clinical Outcome Assessment)ePRO (electronic Patient-Reported Outcome)Microsoft Power Platformtraining enablementchange managementSOP/process updatesvendor coordinationcutoverhypercaregovernancefinancials and vendor contractsoperating model optimizationlicensesservicesinfrastructure
Soft Skills
collaborationstakeholder managementdrives enhancementsprimary interface between business and IT delivery/operationsclear communicationissue resolutiontimely decisionstraining enablementcommunicationscontinuous feedback loops with study teamsprioritizationleadership
Keywords for Your Resume
SpclstTechnical Product Managementproduct visionproduct roadmapOKRsObjectives and Key ResultsKPIsKey Performance Indicatorsend-to-end lifecycleclinical development systemsGxPGood PracticeCSVComputer System ValidationAmazon Web ServicesAWSAliCloudEDCElectronic Data CaptureCTMSClinical Trial Management SystemeTMFelectronic Trial Master FilePV databasepharmacovigilance databaseIRT/RTSMInteractive Response TechnologyRandomization and Trial Supply ManagementeCOAelectronic Clinical Outcome AssessmentePROelectronic Patient-Reported OutcomeMicrosoft Power Platformbacklogrelease plancutoverhypercaredata integration
Deal Breakers
Must have experience with GxP/CSV compliance for computer systems, Must have experience integrating clinical development systems in cloud environments (AWS/AliCloud)
Get matched to jobs like this
Luna finds roles that fit your skills and career goals — no endless scrolling required.
Create a Free Profile