Site Activation & Country Approval Specialist

About the role

Thermo Fisher Scientific is seeking a Site Activation & Country Approval Specialist to support the start‑up of clinical trials worldwide. You will coordinate regulatory submissions, site activation activities, and country‑specific requirements, working closely with investigators, sponsors, and internal teams to ensure efficient and compliant study initiation.

Key responsibilities

• Coordinate and support site activation to meet study start‑up timelines and milestones.
• Prepare, review, and manage regulatory submissions to local authorities, ethics committees, and other agencies.
• Develop and execute country‑specific regulatory and site activation strategies.
• Maintain essential site and regulatory documentation in line with local regulations and company procedures.
• Assist with site agreement negotiations, budgets, and document collection.
• Serve as the primary contact for submission and activation activities at the country level.
• Ensure compliance with SOPs, client requirements, ICH‑GCP guidelines, and applicable regulatory standards.
• Monitor trial status information and maintain accurate study records in company systems.
• Identify, escalate, and help resolve regulatory or start‑up issues that could impact timelines.
• Contribute to process‑improvement initiatives and mentor team members when applicable.

Required profile

• Bachelor’s degree in Life Sciences, Healthcare, or a related field.
• Experience in clinical trial start‑up, regulatory submissions, or site activation.
• Strong understanding of local regulatory environments and ethics committee processes.
• Excellent organizational and communication skills.

Required skills

• Knowledge of ICH‑GCP guidelines and regulatory standards.
• Familiarity with SOPs and compliance documentation.
• Ability to manage multiple projects and meet tight deadlines.

What we offer

• Opportunity to work on innovative therapies with a global leader in clinical research.
• Collaborative environment with cross‑functional teams.
• Professional development and mentorship opportunities.