About the role
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.