This is a fully remote position, open to applicants in Italy.

📋 Description

• Ensure the appropriate execution of clinical trials in alignment with the Study Monitoring Plan and applicable laws, as well as Good Clinical Practices.

• Oversee the operational components for the execution of clinical trial activities at designated investigator sites, from site activation to database lock.

• Collaborate with the study team as necessary, and facilitate the flow of information among team members, vendors, and designated investigator sites.

• Monitor adverse events (AEs) and serious adverse events (SAEs) at the site level, coordinating with the Drug Safety Unit and following up with investigator sites as required.

⛳️ Requirements

• Bachelor’s degree in life sciences or a professional degree in life sciences such as nursing, pharmacy, medical background, or an equivalent qualification.

• In-depth knowledge of clinical trial methodologies, ICH/GCP, FDA, and local regulations.

• A minimum of 3.5 years of relevant experience in monitoring clinical research sites, preferably in Oncology.