Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description

Join Us as a Country Approval Specialist – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our global team, you’ll have the opportunity to participate in the management and preparation, review, and coordination of Country Submissions in line with the global submission strategy. As a Country Approval Specialist, you'll play a key role in ensuring that submissions are managed effectively and align with our strategic goals.

What You’ll Do:
OBJECTIVES/PURPOSE
- Supporting the facilitation of site start up and communication with internal and external team members to ensure prompt site approval and study timelines are achieved.
- Support sites and study teams to achieve rapid site start up.

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ACCOUNTABILITIES
- 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 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 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 up

DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
- Understanding of the pharma

📌 Country Approval Specialist (Milano)
🏢 Thermo Fisher Scientific
📍 Milano