Study Site Specialist

Advanced Clinical; España; Remote; EUR 48,000 - 64,000; Full time

Job summary

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.

Qualifications

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

Responsibilities

• 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

Skills

Regulatory knowledge

Informed consent preparation

Documentation & communication

Multitasking & prioritization

Independent remote work

EU CTR / CTIS submissions

Spanish & English proficiency

Education

Bachelor’s degree in science/life sciences

Tools

Veeva Vault

Job description

We are seeking an experienced Study Site Specialist to join a global clinical res

Search programme. This is a permanent, fully remote position for candidates based in Spain.

• Location: Spain
• Working arrangement: Fully remote
• Employment type: Permanent

Position Summary

The Study Site Specialist will manage site start-up activities in Spain, from site identification and feasibility through to regulatory approval and activation.

The main responsibilities will include preparing country documentation and informed consent forms, completing EU Clinical Trials Regulation submissions through CTIS, selecting suitable sites and granting Regulatory Greenlight.

Key Responsibilities

• Manage end-to-end study site start-up activities in Spain.
• Prepare and review country-level documentation, including informed consent forms.
• Complete EU CTR submissions through CTIS.
• Coordinate site identification, feasibility and qualification activities.
• Collect, review and track essential regulatory documents.
• Complete Ethics Committee and Regulatory Authority submissions.
• Support site contract and budget negotiations.
• Act as the primary point of contact for sites and internal study teams.
• Bring sites to Regulatory Greenlight and support ongoing site maintenance.
• Maintain accurate tracking systems and provide progress reports.
• Identify potential issues proactively and recommend appropriate solutions.
• Demonstrable experience completing EU CTR and CTIS submissions.
• Strong knowledge of Spanish regulatory and site start-up requirements.
• Hands-on experience preparing and reviewing informed consent forms.
• At least five years of relevant site start-up, contract management or clinical operations experience within a pharmaceutical company, biotechnology company or CRO.
• Good knowledge of ICH-GCP, EU clinical trial regulations and local Spanish requirements.
• Experience collecting and managing essential study documentation.
• Bachelor’s degree in science, life sciences or another relevant discipline.
• Fluent Spanish and strong professional English.
• Excellent organisational, documentation and communication skills.
• Ability to manage multiple priorities and deliver high-quality work within agreed timelines.
• Ability to work independently in a fully remote environment.
• Experience with Veeva Vault or comparable clinical trial management systems.
• Previous involvement in site contract and budget negotiations.
• Experience managing the full site start-up process through to Regulatory Greenlight.