Job Description
At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
We are looking for a Clinical System Administrator to join our A-team (hybrid*). As a Clinical System Administrator at Allucent, you will be responsible for the configuration, maintenance, and administration of clinical systems, with a primary focus on Veeva Vault applications (eTMF, CTMS, Payments, etc.) and pharmacovigilance systems. This role is critical to ensuring the seamless operation of these platforms, supporting clinical trial activities, and ensuring compliance with regulatory requirements. The Clinical Systems Administrator will have hands-on experience with Veeva Vault products, as well as knowledge of pharmacovigilance systems used for safety reporting and adverse event management. The Clinical Systems Administrator will collaborate with internal teams, including clinical operations, IT, and pharmacovigilance, to optimize system performance and provide end-user support.
In this role your key tasks will include:
- Administer and configure Veeva Vault applications (eTMF, CTMS, Payments, etc.), ensuring the systems are operating efficiently and in compliance with regulatory standards (FDA, ICH).
- Support the administration and maintenance of pharmacovigilance systems, ensuring compliance with safety reporting requirements and regulatory standards (FDA, EMA).
- Provide technical support to end-users across clinical operations, pharmacovigilance, and other departments. Train users on system functionality, best practices, and regulatory compliance requirements.
- Lead efforts to configure clinical and pharmacovigilance systems according to business needs, optimizing workflows, and ensuring alignment with operational goals.
- Ensure data integrity and proper system validation according to regulatory standards. Assist with audits and inspections as needed to demonstrate compliance with regulatory requirements.
- Manage system changes using proper change control procedures. Maintain comprehensive documentation of system configurations, user access, and administration activities.
- Collaborate with clinical operations, pharmacovigilance, quality assurance, and IT teams to ensure that system enhancements and configurations meet business and regulatory needs.
- Work with IT to ensure clinical and pharmacovigilance systems are properly integrated with other enterprise applications, such as ERP and data warehouses, to ensure seamless data flow and reporting.
- Liaise with Veeva and other third-party vendors to resolve system issues, manage updates, and ensure the systems are functioning according to business and regulatory requirements.
- Develop and maintain reports and dashboards for clinical and pharmacovigilance data, supporting business decision-making and ensuring compliance with reporting requirements.
- Review, improve and evaluate IT processes and procedures within the Quality Management System.
