04 ago
|
Thermo Fisher Scientific
|
Buenos Aires
04 ago
Thermo Fisher Scientific
Buenos Aires
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Join Us as a Site Activation & Country Approval Specialist
Make an Impact at the Forefront of Innovation
At Thermo Fisher Scientific, our Clinical Research team supports leading pharmaceutical, biotechnology, and emerging biopharma companies in advancing innovative therapies worldwide. Having contributed to thousands of clinical trials across more than 100 countries, we are committed to accelerating research that improves patient lives.
As a Site Activation & Country Approval Specialist, you will play a key role in the successful start-up of clinical trials by supporting regulatory submissions, site activation activities, and country-specific requirements. Working closely with investigative sites, regulatory authorities, sponsors, and internal teams, you will help drive efficient study start-up while ensuring compliance with local regulations, company procedures, and general project strategies.
Position Summary
The Site Activation & Country Approval Specialist is responsible for supporting and coordinating site activation and regulatory submission activities to ensure clinical studies are initiated efficiently and in compliance with applicable regulations. This role partners with cross-functional teams to manage submission strategies, site documentation, regulatory approvals, site agreements, and start-up timelines while maintaining high standards of quality, accuracy, and operational excellence.
Key Responsibilities:
- Coordinate and support site activation activities to achieve study start-up timelines and project milestones.
- Prepare, review, and manage regulatory submissions to local regulatory authorities, ethics committees, and other applicable agencies.
- Support the development and execution of country-specific regulatory and site activation strategies.
- Prepare and maintain essential site and regulatory documentation in accordance with local regulations and company procedu
📌 Country Approval Specialist (Buenos Aires)
🏢 Thermo Fisher Scientific
📍 Buenos Aires