Job Title

Key Accountabilities:Create eCRF specifications, design, develop and unit test and functionally validate clinical trial setup processCreate edit check specifications and program or modify checks at study level within EDCSetup different instances of study URL (eg: UAT, production, testing etc.,)Setup and configure user accounts for study teamsSetup and manage blinded and unblinded study configurationsBe the SME for all database related activitiesSetup, 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.,Familiar with custom functions within EDC systemsWork closely with EDC vendors regarding any tool related issues in the systemAbility to troubleshoot database setup as per study needsPrepare, test and implement post production changes as per study needsArchive and retire the study URL after database lockPartner with appropriate team members to establish technology standards and governance modelsEstablish and support business process SOPs.Oversee system delivery life cycle in collaboration with appropriate partners including Clinical Operations, Clinical Supplies, IT, and Quality organizationsBe a primary change agent to ensure adoption of new capabilities and business processBe the contact for Clinical Technology vendors to ensure established milestones are met with the highest degree of quality.Work with leaders to resolve issues affecting the delivery of clinical trialsCollaborate with standards team in creating standard CRF libraries for study level consumptionWork closely with data engineers and data management programmers at study level integration and deliveryLead technology vendor oversight activities.Be a process expert for operational and oversight models.Partner with appropriate team members, technology vendors, and CRO partners to avoid and resolve risks.Confirm archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documentsParticipate in preparing function for submission readiness and may represent Clinical Information Operations (CIO) group in a formal inspection or audit.Track study deliverables and evaluate study metrics to mitigate risk for major data management deliverables.Adaptable to new ways of working using technology to accelerate clinical trial setupKnowledge of drug development process.Experience in Data Management, Programming, Clinical IT, or other Clinical Research related fields.Hands-on experience study build experience in Veeva and RAVE.Experience programming in CQL, working with JSON format and/or C# is preferredExperience integrating other clinical trial modules (e.g.: lab, safety, IRT, coding etc.,) with the EDC systemUnderstanding of industry standard technologies to support Clinical Development needs (e.g., CTMS, SAS, R or Python, Data Warehouses, SharePoint)