Senior Clinical Study Manager

01 ott - Italia
Iqvia

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.MAIN RESPONSIBILITIESPlans 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 DeliverablesLeads and manages the clinical teamsLeads and supports the relevant staff (ie. local start-up staff, local and global regulatory affairs staff, inhouse clinical staff, etc) to drive successful activation of trial sitesMonitors the quality of clinical activities and addresses quality issues with the appropriate team memberReviews and approves site visit reports within agreed turnaround times and ensures tracking, follow up, and resolution of site issuesWorks with the relevant staff to identify data related issues and risks to clinical activities; develops contingency and mitigation plans to minimize risksCreates and maintains project-specific plans, documents, and tools for the clinical teamSupports the CRAs with site monitoring activities and provides suggestions and solutions to site issuesOversees the relevant regulatory and in-house clinical staff to ensure that all non-safety periodic updates, progress reports, and rene

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