Veeva EDC Programmer

Key Accountabilities:\nCreate eCRF specifications, design, develop and unit test and functionally validate clinical trial setup process\nCreate edit check specifications and program or modify checks at study level within EDC\nSetup different instances of study URL (eg: UAT, production, testing etc.,)\nSetup and configure user accounts for study teams\nSetup and manage blinded and unblinded study configurations\nBe the SME for all database related activities\nSetup, configure, unit test and functionally validate and integrate other modules within the EDC ecosystem such as coding, integration of IRT, safety system, local labs etc.,\nFamiliar with custom functions within EDC systems\nWork closely with EDC vendors regarding any tool related issues in the system\nAbility to troubleshoot database setup as per study needs\nPrepare, test and implement post production changes as per study needs\nArchive and retire the study URL after database lock\nPartner with appropriate team members to establish technology standards and governance models\nEstablish and support business process SOPs.\nOversee system delivery life cycle in collaboration with appropriate partners including Clinical Operations, Clinical Supplies, IT, and Quality organizations\nBe a primary change agent to ensure adoption of new capabilities and business process\nBe the contact for Clinical Technology vendors to ensure established milestones are met with the highest degree of quality.\nWork with leaders to resolve issues affecting the delivery of clinical trials\nCollaborate with standards team in creating standard CRF libraries for study level consumption\nWork closely with data engineers and data management programmers at study level integration and delivery\nLead technology vendor oversight activities.\nBe a process expert for operational and oversight models.\nPartner with appropriate team members, technology vendors, and CRO partners to avoid and resolve risks.\nConfirm archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documents\nParticipate in preparing function for submission readiness and may represent Clinical Information Operations (CIO) group in a formal inspection or audit.\nTrack study deliverables and evaluate study metrics to mitigate risk for major data management deliverables.\nAdaptable to new ways of working using technology to accelerate clinical trial setup\nKnowledge of drug development process.\nExperience in Data Management, Programming, Clinical IT, or other Clinical Research related fields.\nHands-on experience study build experience in Veeva and RAVE.\nExperience programming in CQL, working with JSON format and/or C# is preferred\nExperience integrating other clinical trial modules (e.g.: lab, safety, IRT, coding etc.,) with the EDC system\nUnderstanding of industry standard technologies to support Clinical Development needs (e.g., CTMS, SAS, R or Python, Data Warehouses, SharePoint)