IT Medidata

ITMedidata (L3 Support)

We are hiring a Medidata CTMS/SSU/eTMF Techno-Functional Consultant with 3–8 years of experience to configure, administer, and support Medidata Clinical Trial systems. The role involves L3 production support, incident/problem/change management, system enhancements, release management, audit support, and ensuring compliance with FDA, ICH, GCP, and GxP standards. You will collaborate with business stakeholders, IT teams, and vendors to maintain system stability, data integrity, and clinical operations.

Key Skills:

• Medidata CTMS, SSU & eTMF Administration/Configuration
• L3 Production Support & Incident Management
• Change & Release Management
• Clinical Trial Operations
• FDA, ICH, GCP & GxP Compliance
• Data Integrity, Audit & Validation Support
• Root Cause Analysis (RCA)
• Stakeholder & Vendor Management

Requirements:

• Bachelor's degree in Life Sciences, Computer Science, IT, or related field.
• 3–8 years of hands-on experience with Medidata CTMS/SSU/eTMF.
• Strong understanding of clinical trial processes and regulatory compliance.
• Experience with EDC systems, databases, analytics, or reporting tools is an added advantage.