Principal Programmer Veeva EDC

5 months ago

Nagpur, India SIRO Clinpharm Pvt. Ltd. Full time
  • 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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