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.,
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
