Access Management Specialist – Clinical Data

About the role

The Access Management Specialist will administer and support clinical systems and Oracle‑based platforms, ensuring secure user access and compliance throughout clinical trial activities.

Key responsibilities

• Manage user access and permissions across EDC, eTMF and other clinical applications, supporting onboarding, modifications and removals.
• Maintain validated state of clinical systems, develop and execute validation test scripts, and support audits and quality reviews.
• Provide Level 2 support to clinical users, troubleshoot issues, track tickets and propose improvements.
• Collect user requirements, act as liaison between business and technical teams, and support implementation of new functionalities.

Required profile

• Master's degree in Engineering, Computer Science, Life Sciences or related field.
• 2–5 years of experience in clinical systems administration, access management or clinical trial support.
• Strong knowledge of ICH‑GCP/GxP regulations and Computerized System Validation (CSV) methodologies.

Required skills

• Oracle solutions
• Electronic Data Capture (EDC) systems
• Electronic Trial Master File (eTMF) platforms
• Computerized System Validation (CSV) processes
• Ticketing and issue‑tracking tools