Trial Master File Specialist (TMFS) II/Snr TMF - TMF and ALCOA principles experi

Assists with set up and maintenance of the Trial Master File (TMF). Serves as main point of contact for all TMF-related activities for assigned projects. Processing and indexing of project documents for the TMF in accordance with project-specific guidelines and relevant SOPs. Upon study closure, assists in reconciliation of TMF; ships files to client, if agreed, and prepares TMF for archiving. Tracks and performs quality check of documents using internal systems and ALCOA+ principles. Prepares study team reports or updates regarding status of TMF as required. Supports preparations for study specific audits, attends in-house project audits if required, takes part in analysis of received audit report. TMF Specialist II can also propose and oversee completion of Corrective and Preventative Action Plan with respect to all TMF aspects of the project. TMF maintenance and quality check experience ALCOA Principles. Administrative work experience, preferably in an international Clinical Research setting. Proficiency in Excel. Ability to take over responsibility for TMF quality; follow up on topics independently. Very good English oral and written communication skills. When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting. We are diverse in many ways, yet our values unite us.