Access Management Specialist - Clinical Data

Job Description

The Access Management Specialist is responsible for the administration and support of clinical systems and Oracle-based platforms. The role ensures secure user access management, system validation compliance, user support, and continuous improvement of clinical applications used throughout clinical trial activities.

System Administration & Access Management

• Manage user access and permissions across multiple clinical applications (EDC, eTMF, and other clinical systems).
• Ensure compliance with access management processes and security requirements.
• Support onboarding, modification, and removal of user accounts.

System Validation & Compliance

• Maintain the validated state of clinical systems.
• Develop, execute, and document validation test scripts.
• Ensure compliance with Computerized System Validation (CSV) requirements.
• Support audits and quality reviews related to system validation activities.

User Support & Incident Management

• Provide Level 2 support to clinical users.
• Investigate, troubleshoot, and resolve system-related issues.
• Track and manage support requests through ticketing systems.
• Monitor recurring issues and propose improvement actions.

Requirements & Continuous Improvement

• Collect and document user requirements for system enhancements.
• Act as a liaison between business users and technical teams.
• Participate in team meetings and contribute to system improvement initiatives.
• Support the implementation of new functionalities and process enhancem

Qualifications

• Master's Degree in Engineering, Computer Science, Life Sciences, or a related scientific field.
• 2 to 5 years of experience in clinical systems administration, access management, or clinical trial support environments.

Technical Skills

• Experience in clinical trial system administration and support.
• Knowledge of clinical research processes and regulations, including ICH-GCP/GxP.
• Understanding of Computerized System Validation (CSV) methodologies.
• Experience with user access management and application administration.
• Knowledge of eTMF, EDC, and other clinical trial systems.
• Previous experience with Oracle solutions is highly desirable.
• Familiarity with ticketing and issue-tracking tools.

Soft Skills

• Strong communication and interpersonal skills.
• Excellent listening and user support capabilities.
• Ability to explain technical concepts to non-technical users.
• Analytical and problem-solving mindset.
• Solution-oriented approach.
• Organization, rigor, and attention to detail.
• Open-mindedness and adaptability.

Additional Information