eTMF Lead

The eTMF Lead, in compliance with the applicable procedures, is mainly responsible for the eTMF

management, as Process Owner, with the aim of maintaining in good health the documentation

archived in the system. Acts as responsible for training both eTMF Assistant and eTMF Specialist on

documentation management and archiving procedures to ensure high documents quality standards. Contributes to the management and development of procedures relating to the activities in which is involved, ensuring that the activities of the whole Unit meet the quality standards required by the company.

Some of what you'll do:

• Assist the project team members in the creation of a new study in the eTMF, completing the setup, in good coordination with the study team
• Deliver training to new eTMF users, providing a comprehensive overview of system functionality and operational workflows
• Follow up with the users to ensure that the training process has b...