The IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department is supporting our client’s project team in the execution of clinical trials. Joining the team provides the opportunity to manage clinical research projects in different therapeutic areas and to cooperate closely with one of our key clients.
We currently offer the exciting opportunity to join the team as Clinical Study Manager 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 local level.
Plans and leads execution of day-to-day activities for the monitoring of a complex clinical study and communicates consistently with the clinical team providing project objectives, expectations, and status updates.
Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
Provides Project Oversight & Leadership for Clinical Deliverables
Leads and manages the clinical teams
local start-up staff, local and global regulatory affairs staff, inhouse clinical staff, etc) to drive successful activation of trial sites
Reviews and approves site visit reports within agreed turnaround times and ensures tracking, follow up, and resolution of site issues
Works with the relevant staff to identify data related issues and risks to clinical activities; Creates and maintains project-specific plans, documents, and tools for the clinical team
Supports the CRAs with site monitoring activities and provides suggestions and solutions to site issues
Oversees the relevant regulatory and in-house clinical staff to ensure that all non-safety periodic updates, progress reports, and renewals, and/or end of study notifications are performed in accordance with the trial protocol, local regulations, ICH GCP, and any other processes or procedures governing the clinical trial
Acts as coordinating manager t
📌 Clinical Study Manager (Italia)
🏢 Iqvia
📍 Italia