Global Site Activation & Country Approval Lead

ThermoFisher Scientific; Comisión de Fomento de Perú; Híbrido; ARS 137.587.000 - 183.450.000; Jornada completa

Descripción de la vacante

Thermo Fisher Scientific's Clinical Research team supports leading pharmaceutical and biotech companies in advancing innovative therapies worldwide. The Site Activation & Country Approval Specialist helps start-up of trials by coordinating regulatory submissions, site activation, and country-specific requirements, collaborating with sites, authorities, sponsors and internal teams.

In this role, you will ensure compliance with local regulations, ICH-GCP guidelines, and SOPs while managing

Formación

• Bachelor’s degree in life sciences or related field.
• Experience in clinical trial start-up and regulatory submissions.
• Knowledge of ICH-GCP guidelines and good documentation practices.

Responsabilidades

• Coordinate and support site activation activities to achieve study start-up timelines.
• Prepare, review, and manage regulatory submissions to local authorities and ethics committees.
• Support country-specific regulatory and site activation strategies.
• Maintain essential site and regulatory documentation per SOPs.
• Assist with site agreements, budgets, and essential document collection.
• Collaborate with investigators, sponsors, and internal teams to enable timely activations.
• Serve as a primary contact for submissions and country-level activation activities.
• Ensure compliance with ICH-GCP, SOPs, and regulatory standards.
• Coordinate with departments to align submission and activation with study timelines.
• Monitor trial status and documentation in company systems.
• Support regulatory compliance reviews and inspection readiness.

Conocimientos

Clinical research

Regulatory submissions

Site activation

ICH-GCP

Stakeholder management

Educación

Bachelor’s degree in Life Sciences

Herramientas

Microsoft Office

CTMS

Descripción del empleo

Thermo Fisher Scientific's Clinical Research team supports leading pharmaceutical and biotech companies in advancing innovative therapies worldwide. The Site Activation & Country Approval Specialist helps start-up of trials by coordinating regulatory submissions, site activation, and country-specific requirements, collaborating with sites, authorities, sponsors and internal teams.

In this role, you will ensure compliance with local regulations, ICH-GCP guidelines, and SOPs while managing