Marina Delogu

The role involves identifying, training/initiating, and closing study sites, conducting remote site monitoring visits, training site staff on essential processes and systems, collecting and managing essential documents, managing study sites and the required protocols, amendments, and/or deviations, ensuring accurate data reporting and maintaining timelines

Additionally, it includes start-up activities such as feasibility, prepare and submit documents to the relevant authorities, obtaining regulatory approvals, draft of contracts and ICF.

Management of Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) process: receipt, data entry, quality control, narrative writing, possible follow-up, medical assessment, and expedited or aggregate reporting, monitoring subjects using Medidata.

Provide support to healthcare professionals and patients involving the receipt and tracking of medical inquiries, adverse events, and product quality complaints

Receive, triage, review, and process safety data from various sources.

Process lifecycle safety data according to applicable regulations, guidelines, standard operating procedures, and project requirements.
Work with the whole portfolio of the client, including the following therapeutic areas: respiratory, vaccines, immuno-inflammation, infectious diseases and global health, oncology, HIV.

Prioritizing cases based on validity and seriousness. Reviewing translations of source documents from non-English to English in adverse events forms. Using process guidance documents to check if the relevant adverse event terms and safety data were translated and captured appropriately by the Translation Associate (ITA) in AE
forms.