Job descriptionKey Accountabilities: - Create eCRF specifications, design, develop and unit test and functionally validate clinical trial setup process - Create edit check specifications and program or modify checks at study level within EDC - Setup different instances of study URL (eg: UAT, production, testing etc.,) - Setup and configure user accounts for study teams - Setup and manage blinded and unblinded study configurations - Be the SME for all database related activities - Setup, 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 systems - Work closely with EDC vendors regarding any tool related issues in the system - Ability to troubleshoot database setup as per study needs - Prepare, test and implement post production changes as per study needs - Archive and retire the study URL after database lock - Partner with appropriate team members to establish technology standards and governance models - Establish and support business process SOPs. - Oversee system delivery life cycle in collaboration with appropriate partners including Clinical Operations, Clinical Supplies, IT, and Quality organizations - Be a primary change agent to ensure adoption of new capabilities and business process - Be 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 trials - Collaborate with standards team in creating standard CRF libraries for study level consumption - Work closely with data engineers and data management programmers at study level integration and delivery - Lead 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) documents - Participate 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 setup - Knowledge 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 preferred - Experience integrating other clinical trial modules (e.g.: lab, safety, IRT, coding etc.,) with the EDC system - Understanding of industry standard technologies to support Clinical Development needs (e.g., CTMS, SAS, R or Python, Data Warehouses, SharePoint)