Principal Programmer Veeva EDC

2 weeks ago

India SIRO Full time ₹ 9,00,000 - ₹ 12,00,000 per 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.,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

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