Job description

Experience 4-8 Years eCRF specifications, design, develop and unit test and functionally validate clinical trial setup process edit check specifications and program or modify checks at study level within EDC SME (Subject Matter Expert) for all database related activities Familiar with custom functions within EDC system Prepare, test and implement postproduction changes as per study needs Work with leaders to resolve issues affecting the delivery of clinical trials 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 submission readiness and may represent Clinical Information Operations (CIO) group in a formal inspection or audit Adaptable to new ways of working using technology to accelerate clinical trial setup

Skills Required

Key Skills

• ECRF
• EDIT CHECKS
• VEEVA

Other Information