Internship Clinical Development & Operations

at  BI Italia Spa

THE INTERNSHIP

In this role you will join the Clinical Development & Operations team in our offices based in Milan. You will support operational and scientific set-up, execution, and delivery of the clinical trials at the local level. COS contribute to the delivery of Company’s pipeline through support different roles within Italian Clinical Research & Development (CD&O).

REQUIREMENTS

• Scientific Master Degree; Master’s program in clinical/pharmaceutical areas would be considered a plus.
• Good knowledge of Microsoft Office Package
• Good command of the English language and native level of Italian language
• Basic knowledge/experience in Project Management would be considered a plus
• Strong team working and communication skills
• Confident in working simultaneously on multiple projects

• Support ethical procedures managed by the CRO to start up clinical studies at central (EU-CTR) and sites’ level, in compliance with existing legislation, both national and international.
• Support the negotiation and finalization of study contracts according to the current laws and internal procedures in collaboration with CD&O, the CRO, and Legal & Compliance Department.
• Maintenance of trackers and activities to support trials for activities not outsourced to a CRO as wel as tracking of a significant number of trial specific documents and activities.
• Suppport the planning, implementation, and tracking of the clinical trial process as well as risk mitigation, working on the clinical trials’ monitoring, site engagement, conduct and closeout visit.
• Support CD&O in the relationships with external experts, investigational sites, Patient Organizations and other stakeholders in a cross-functional collaboration amongst CD&O and appropriate functions (Medical Affairs, Patient Advocacy, Regulatory, Pharmacovigilance, etc..)