Expert Veeva EDC Programmer

4 days ago

Kollam, India SIRO Clinpharm Pvt. Ltd. Full time

Create eCRF specifications, design, develop and validate clinical trial setup processCreate edit check specifications and setup edit checks at trial levelImplement UAT scripts to test the setup of the clinical studySetup different instances of study URL(eg: UAT, production, testing etc.,)Setup and configure user accounts for study teamsSetup and manage blinded and unblinded study configurationsBe the SME for all EDC database related activitiesSetup, 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 systemsAbility to troubleshoot database setup as per study needsPrepare, test and implement post production changes as per study needsPartner with appropriate team members to establish technology standards and governance modelsOversee system delivery life cycle in collaboration with appropriate partners including Clinical Operations, Clinical Supplies, IT, and Quality organizationsBe a primary change agent to ensure adoption of new capabilities and business processBe 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 trialsWork closely with data engineers and data management programmers on study level integrations and deliveriesLead 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) documentsParticipate 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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