Remote Spain Site Start-Up Specialist CTR/CTIS

Advanced Clinical; España; Remote; EUR 48.000 - 64.000; Vollzeit

Zusammenfassung

Advanced Clinical seeks an experienced Study Site Specialist for a fully remote role based in Spain. You will lead end-to-end site start-up activities, prepare country documentation and informed consent forms, and manage regulatory submissions through CTIS.

You will coordinate site identification, feasibility, and qualification efforts, maintain essential documents, and support contract and budget negotiations.

Qualifikationen

• Minimum 5 years in site start-up/clinical operations
• Experience with site contract and budget negotiations
• Experience in regulatory submissions (EU CTR/CTIS)

Aufgaben

• Manage end-to-end study site start-up activities in Spain
• Prepare country-level documentation and informed consent forms
• Complete EU CTR submissions through CTIS
• Coordinate site identification, feasibility and qualification activities
• Maintain regulatory documents and track progress
• Support ethics committee and regulatory authority submissions
• Act as primary liaison for sites and internal teams
• Bring sites to Regulatory Greenlight and oversee site maintenance
• Provide progress reports and proactive issue resolution
• Experience with site start-up and contract management in pharma/biotech/CRO

Kenntnisse

Regulatory knowledge

Informed consent preparation

Documentation & communication

Multitasking & prioritization

Independent remote work

EU CTR / CTIS submissions

Spanish & English proficiency

Ausbildung

Bachelor’s degree in science/life sciences

Tools

Veeva Vault

Jobbeschreibung

Advanced Clinical seeks an experienced Study Site Specialist for a fully remote role based in Spain. You will lead end-to-end site start-up activities, prepare country documentation and informed consent forms, and manage regulatory submissions through CTIS.

You will coordinate site identification, feasibility, and qualification efforts, maintain essential documents, and support contract and budget negotiations.