Clinical Trial Setup Specialist

4 days ago


junagadh, India beBeeEDC Full time

Job Opportunity: Expert Veeva EDC ProgrammerThe ideal candidate will create eCRF specifications, design, develop and validate clinical trial setup processes.Develop edit check specifications and set up edit checks at the trial level.Implement UAT scripts to test the setup of clinical studies.Set up different instances of study URLs (e.g., UAT, production, testing etc.).Configure user accounts for study teams.Manage blinded and unblinded study configurations.Be the subject matter expert for all EDC database-related activities.Set up, configure, validate and integrate other modules within the EDC ecosystem such as coding, integration of IRT, safety systems, local labs etc.Understand when custom functions are required within EDC systems.Troubleshoot database setup as per study needs.Prepare, test and implement post-production changes as per study needs.Collaborate with team members to establish technology standards and governance models.Oversee system delivery life cycles in collaboration with partners including Clinical Operations, Clinical Supplies, IT, and Quality organizations.Drive change adoption to ensure new capabilities and business processes.Partner with 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.Collaborate with data engineers and data management programmers on study-level integrations and deliveries.Lead technology vendor oversight activities.Partner with team members, vendors, and CROs to mitigate risks.Confirm archival and inspection readiness of Clinical Technology Trial Master File documents.Participate in preparing submissions and may represent the group in a formal inspection or audit.Track study deliverables and evaluate metrics to mitigate risk for major data management deliverables.



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