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

📋 Description

• Accountable for overseeing site management, monitoring, and closure of designated clinical trial investigator sites.

• Ensure the safety of participants and the high-quality execution of studies.

• Guarantee that clinical trials are conducted in line with the Study Monitoring Plan, relevant laws, and Good Clinical Practices.

• Manage the operational facets of clinical trial activities at designated investigator sites, from site activation to database lock.

• Ensure that timelines and quality deliverables are achieved.

• Facilitate effective communication among study team members, vendors, and assigned investigator sites.

• Monitor site-level Adverse Events (AEs) and Serious Adverse Events (SAEs).

• Collaborate with the Drug Safety Unit and follow up with investigator sites to address necessary SAE report information.

• Act as a contact point for audits.

• Lead the development and verification of Audit Observation CAPA when necessary.

⛳️ Requirements

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

• Extensive understanding of clinical trial methodologies, ICH/GCP, FDA, and local regulations.

• At least 5 years of relevant experience in clinical research site monitoring.

• Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine, or Infectious Diseases.

• Candidates who are available to start immediately will be prioritized during the review process.

🏝️ Benefits

• Fixed-term contract until April 2027, with the possibility of extension or transition to a permanent position thereafter.