United States onlyRole: Principal Database Developer – Veeva EDC Programmer
Job Location: Remote working
Experience : Total 4-5 years but EDC programming at least a year
- Create eCRF specifications, design, develop and validate clinical trial setup process
- Create edit check specifications and setup edit checks at trial level
- Implement UAT scripts to test the setup of the clinical study
- 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 EDC database related activities
- Setup, configure, validate and integrate other modules within the EDC ecosystem such as coding, integration of IRT, safety system, local labs etc.,
Requirements
Understanding of when custom functions are required within EDC systems
- Ability to troubleshoot database setup as per study needs
- Prepare, test and implement post production changes as per study needs
- Partner with appropriate team members to establish technology standards and governance models
- 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
- Work closely with data engineers and data management programmers on study level integrations and deliveries
- Lead technology vendor oversight activities.
- 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.
