Senior Clinical Technology Specialist

2 days ago

Eluru, India beBeeClinicalTechnologyExpert Full time

We are seeking an expert in Clinical Technology to lead our team. The successful candidate will have a strong background in eCRF specifications, design, development, and validation of clinical trial setup processes. Clinical Technology Expert The ideal candidate will be responsible for creating edit check specifications, setting up edit checks at the trial level, implementing UAT scripts to test the setup of the clinical study, and setting up different instances of study URLs. Clinical Trial Setup: Create eCRF specifications, design, develop, and validate clinical trial setup processes. Edit Check Specifications: Create edit check specifications and set up edit checks at the trial level. UAT Scripts: Implement UAT scripts to test the setup of the clinical study. Study URL: Set up different instances of study URLs. User Accounts: Set up and configure user accounts for study teams. Blinded and Unblinded Study Configurations: Set up and manage blinded and unblinded study configurations. EDC Database: Be the SME for all EDC database-related activities. Integration: Set up, configure, validate, and integrate other modules within the EDC ecosystem. Custom Functions: Understand when custom functions are required within EDC systems. Troubleshooting: Ability to troubleshoot database setup as per study needs. Post-Production Changes: Prepare, test, and implement post-production changes as per study needs. Technology Standards: Partner with appropriate team members to establish technology standards and governance models. System Delivery Life Cycle: Oversee system delivery life cycle in collaboration with appropriate partners. Change Agent: Be a primary change agent to ensure adoption of new capabilities and business processes. Clinical Technology Vendors: Be the contact for Clinical Technology vendors to ensure established milestones are met with the highest degree of quality. Risk Management: Work closely with data engineers and data management programmers on study-level integrations and deliveries. Vendor Oversight: Lead technology vendor oversight activities. Risk Mitigation: Partner with appropriate team members, technology vendors, and CRO partners to avoid and resolve risks. Inspection Readiness: Confirm archival and inspection readiness of all Clinical Technology Trial Master File documents. Submission Readiness: Participate in preparing function for submission readiness and may represent Clinical Information Operations group in a formal inspection or audit. Study Deliverables: Track study deliverables and evaluate study metrics to mitigate risk for major data management deliverables. New Ways of Working: Adaptable to new ways of working using technology to accelerate clinical trial setup.

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