12 ago - Milano
Icon Clinical
Study Start Up Associate IIICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.As a Study Start Up Associate II at ICON, you will lead the initiation of clinical trials, ensuring compliance with regulatory requirements, and contribute to the advancement of innovative treatments and therapies.What You Will Do:You will contribute to site start-up and activation activities, taking responsibility for your deliverables and working collaboratively.Key responsibilities include:Work directly with assigned sites on all site related essential document collection and review.Partner with internal Study Startup team, CROs, Clinical Operations teams,
and TAU partners to improve overall SSU metrics and deliver processes.Ensure standards are applied to the SSU processes across projects.Review site essential documents for start up including but not limited to: ICF, FDF, 1572, CVs etcPromptly recognize and improve potential site activation delays and escalate to appropriate team members.Track all actions and communications with sites to ensure timelines are achieved for studies and sites assigned.Support resolving escalated issues identified by the CROs and Clinical Operations teams in partnership with the internal Study Startup team.Review and provide feedback to management on site performance metrics.Ensure accuracy and completeness of the eTMF for assigned sites during start upYour Profile:You will bring relevant site start-up and activation experience, along with the following qualifications and skills.Required qualifications and experience:BS degree or international equivalent2 or more years of experience in clinical research Site Start Up within a pharmaceutical company, CRO or relevant industry vendor.A
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Michael Page International