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Veeva EDC Programmer
SIRO Clinpharm
posted 7d ago
Job Description
- 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
Employment Type: Full Time, Permanent
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