Remote Poland Study Site Start-Up Lead

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

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.