<p>The <a href="https://himalayas.app/companies/iqvia">IQVIA</a> sponsor-dedicated <b>Clinical Functional Service Partnerships (Clinical FSP) </b>department is supporting our client’s project team in the execution of clinical trials. Joining the team provides the opportunity to manage Early Phase clinical research projects in different therapeutic areas and to cooperate closely with one of our key clients. </p><p>We currently offer the exciting opportunity to join the team as<b> Clinical Trial Manager</b> in full-time and work home-based in Italy. In this role you will be accountable for the operational and scientific oversight, the set-up, execution and delivery of your assigned clinical trials at the regional/local level. working closely together with the Clinical Trial Lead, the CRAs and the regulatory start-up team in the assigned trial. </p><h3>KEY RESPONSIBILITIES</h3><ul><li>Accountable for the operational and scientific oversight, the set-up, execution and delivery of their assigned clinical trials at the regional/local level. CTMs contribute to delivery of sponsor´s pipeline through accurate planning and efficient execution of trials that bring speed &amp; value to participating patients and sites<br>• Provides leadership and direction to the Operational Unit trial team and is accountable for the overall success and delivery of their assigned clinical trial/s according to defined milestones and key performance indicators <br>• Responsible for steering and directing clinical trial activities, including patient and site engagement activities and interaction with multiple internal and external stakeholders and trial team members at a regional/local and global level <br>• Responsible for managing the planning, implementation and tracking of the clinical trial process as well as risk mitigation. The CTM serves as a proactive member of the trial team, liaising closely with the Clinical Trial Leader (“CTL”) on all study-related issues </li> </ul><p><u>Trial Preparation, Conduct and Closeout:</u><br>• Accountable for the trial activities for responsible R/OPU<br>• Verify the trial is conducted in compliance with GCP-ICH, local/global regulations, application SOPs and according to the trial protocol by overseeing CRO and internal team activities <br>• Creation, management, and review of the R/OPU trial budget to verify appropriate level of financial oversight and planning accuracy<br>• Appropriate trial-specific training of R/OPU internal and external partners.<br>• Accurate planning and co-ordination of operational feasibility of trial timelines for their R/OPU; and oversight of trial preparation to verify trial team members are aligned and on track <br>• Verifies and provides input into the country and site level feasibility and OPU commitment <br>• Development and implementation of country level engagement plans, recruitment planning and risk mitigation <br>• Oversees outsourcing of vendor services in the R/OPU in accordance to operating model