Site Activation & Country Approval Specialist

About the role

Thermo Fisher Scientific’s Clinical Research team is seeking a Site Activation & Country Approval Specialist to support the start‑up of clinical trials worldwide. The role ensures regulatory submissions and site activation activities are performed efficiently and in compliance with local regulations.

Key responsibilities

• Coordinate site activation activities to meet study start‑up timelines and project 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.
• Collaborate with investigators, study sites, sponsors and internal stakeholders to facilitate timely approvals.
• Ensure compliance with SOPs, ICH‑GCP guidelines and applicable regulatory standards.
• Monitor trial status information and support inspection readiness activities.
• Identify and escalate regulatory or start‑up issues that could impact timelines.
• Contribute to process‑improvement initiatives and mentor team members where applicable.

Required profile

• Bachelor’s degree in Life Sciences, Healthcare or a related field.
• Experience in clinical trial site activation and regulatory submission processes.
• Strong knowledge of ICH‑GCP, local regulatory requirements and ethical review procedures.
• Ability to work cross‑functionally with investigators, sponsors and internal teams.
• Excellent organizational skills and attention to detail.

Required skills