CLINICAL TRIAL ASSISTANT

We are you?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).#LI-JG2