07 set - Milano
Scienza / Ricerca / Sviluppo
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.
MAIN RESPONSIBILITIES 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.
Leads 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 sites.
Monitors the quality of clinical activities and addresses quality issues with the appropriate team member.
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; develops contingency and mitigation plans to minimize risks.
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 pr
07 set - Milano
Mind The Value
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eBa Ricerca & Selezione
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Disoccupazione
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Tempi Moderni Helvetia