05 set - Italia
ICON Strategic Solutions
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
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 etc
- Promptly recognize and improve potential site activation delays and elevate 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 up
Your 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 equivalent
- 2 or more years of experience in clinical research Site Start Up within a pharmaceutical company, CRO or relevant industry vendor.
- Ability to explain data to facilitate decision making p
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