Clinical Quality Specialist / CSV & Auditing

Exeltis is a leader in the field of Women's Health . It researches, innovates and creates new treatments and devices to improve the health and wellbeing of women all over the world. With a global footprint spanning more than 40 countries, Exeltis has a team of over 4,000 professionals and a global manufacturing network. Exeltis has one overarching goal : to offer women support and care throughout every single stage of their lives.

Position Overview :

The Clinical Trial Assistant (CTA) will support the clinical operations team by managing and maintaining the Trial Master File (TMF); essential to ensure that trial documentation is organized and complies with regulatory standards, playing a critical role in the success of clinical trials. The Clinical Trial Assistant (CTA) also will provide administrative and operational support to the clinical trials team, with a specific focus on managing financial and billing-related tasks for clinical trials. This role requires a strong understanding of invoicing, budget tracking, and financial processes within the context of clinical research.

Key Responsibilities :

• TMF Management : Oversee the setup, maintenance, and close-out of the Trial Master File (eTMF) to ensure completeness, accuracy, and compliance with regulatory requirements (ICH-GCP).
• Documentation Support : Assist in the collection, review, and tracking of essential documents for clinical trials to ensure timely and compliant study startup and maintenance.
• Tracking and Reporting : Maintain and update study trackers to monitor the progress of essential documents and provide regular updates to the clinical team.
• Study Coordination : Provide administrative support to the clinical operations team, including coordinating meetings, preparing minutes, and assisting with vendor qualification processes.
• Compliance Checks : Conduct periodic quality checks of TMF contents to ensure all documentation is audit-ready and compliant with regulatory guidelines.
• Billing and Invoicing : Manage and process invoices related to clinical trials, ensuring accuracy and timely submission to vendors.
• Financial Tracking : Assist in tracking budgets, expenditures, and financial milestones across different clinical studies, ensuring their accurate documentation within the SAP system.
• Document Management : Support clinical operations with the organization, filing, and maintenance of essential trial documentation, ensuring compliance with ICH-GCP guidelines.
• Vendor Communication : Liaise with vendors and service providers to assist in qualification processes and address any discrepancies in billing or financial agreements.
• General Administrative Support : Assist the clinical team with tasks such as meeting scheduling, documentation tracking, taking minutes and preparation of reports.

Requirements :

• Bachelor’s degree preferred in Life Sciences, related field, or equivalent experience.
• Mandatory experience with eTMF : At least 2 years of hands-on experience managing TMF in clinical trials.
• Experience in billing or financial management within a clinical trials setting is required.
• Familiarity with SAP system.
• Strong organizational and multitasking skills, with a keen eye for detail.
• Familiarity with ICH-GCP guidelines and clinical trial documentation processes.
• Strong proficiency in financial systems and MS Office Suite (Word, Excel).