Study Site Specialist

Advanced Clinical; Polska; Remote; PLN 120,000 - 180,000; Full time

Job summary

Advanced Clinical is seeking an experienced Study Site Specialist to manage end-to-end site start-up activities in Poland. The role covers country documentation, regulatory submissions, site selection, and achieving Regulatory Greenlight while working remotely from Poland.

The candidate will bring 5+ years in site start-up or clinical operations, strong ICH-GCP knowledge, and fluency in Spanish and English to coordinate contracts, budgets and stakeholder communications across global study teams.

Qualifications

• Bachelor’s degree in science or life sciences.
• 5+ years in site start-up, contract management or clinical operations.
• Fluent Spanish and professional English.
• Experience with EU CTR and CTIS submissions.
• Strong knowledge of ICH-GCP and EU trial regulations.
• Experience with site contracts and budget negotiations.

Responsibilities

• Manage end-to-end study site start-up activities in Poland.
• Prepare country-level documentation including informed consent forms.
• Complete EU CTR submissions through CTIS.
• Coordinate site identification, feasibility and qualification activities.
• Collect, review and track regulatory documents.
• Submit Ethics Committee and Regulatory Authority documentation.
• Support site contract and budget negotiations.
• Serve as primary contact for sites and internal study teams.
• Bring sites to Regulatory Greenlight and support ongoing site maintenance.
• Maintain accurate tracking systems and progress reports.
• Identify issues and propose solutions.
• Ensure compliance with local and EU requirements.

Skills

Regulatory submissions

Site start-up

Contract negotiations

Project coordination

Documentation management

CTIS submissions

Veeva Vault

Remote work

Multi-tasking

Education

Bachelor’s degree in life sciences

Tools

Veeva Vault

Job description

We are seeking an experienced Study Site Specialist to join a global clinical research programme. This is a permanent, fully remote position for candidates based in Poland.

Position Summary

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

Main responsibilities 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 Poland .
• 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.