TMF Manager (m/w/d)

Our expert team at Randstad professional solutions is currently looking for a freelance Trial Master File Specialist on behalf of a business partner to ensure the completeness and quality of the TMF documentation in clinical trials of our customer. Use our service as a springboard in an attractive company in the pharmaceutical industry at Frankfurt. Apply online now – or contact us by phone or e-mail and contact us without obligation by our friendly colleagues.

Monitoring the completeness, quality and topicality of the Trial Master Files in electronic or paper-based form Conducting regular quality controls and verifications of TMF documents for compliance with good clinical practice (GCP) and ICH guidelines Accurate classification and storage of all study-specific documents Support in the preparation and implementation of TMF-relevant audits and inspections If necessary, training of study teams in relation to the TMF deposit and the relevant processes

Complete training or study in the field of clinical research or document management. Proofable professional experience in the management of the Trial Master Files (TMF) or as a Clinical Research Associate (CRA). Comprehensive knowledge of good clinical practice (GCP) and ICH guidelines (in particular ICH E6). Careful and detailed working. Experience with electronic TMF systems is advantageous.

Attractive possibilities to shorten your personal payment destination No more time-consuming billing required Fast, reliable fee payment Complete project contracts with electronic signature JOBV1_EN