Donatella Ballerini

Ensures that processes related to clinical documentation and training, meet
quality/regulatory standards. Develops proactive strategies to implement GCPcompliant processes. Monitors and assesses clinical trial disclosure requirements,
to ensure that the department is covered by adequate procedures and systems for
training and that training is delivered in accordance with Department needs,
Company’s policies and SOPs; support during Inspection/Audit; to support the
Study Team to ensure a complete and accurate TMF through documentation
quality and consistency; to develop TMF culture through all the clinical process and
ensure the implementation of the eTMF.