Veeva EDC Programmer

Key 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)