Senior RSU Specialist – Remote (Poland)

IQVIA; Warszawa; Remote; PLN 151,000 - 281,000; Full time

Benefits offered by this job

Home-based in Poland

Innovative studies

Therapeutic exposure

Global career development

Collaborative culture

Job summary

IQVIA in Poland is seeking a Senior RSU Specialist to join our FSP team. This home-based role requires deep knowledge of local regulatory requirements, site activation processes, and contract negotiations.

Fluency in Polish with strong English communication is essential. You will coordinate regulatory submissions, ethics submissions, ICFs, CTAs, and other essential documents, acting as the main contact for sites, Site Activation Managers, and project teams while ensuring timelines and quality.

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• 3.5–5 years in clinical research or site activation.
• Experience with regulatory submissions and CTAs.
• Knowledge of local and international trial regulations.
• Polish language fluency with strong English skills.

Responsibilities

• Serve as primary contact for investigative sites and internal teams.
• Coordinate country-specific site activation and regulatory activities.
• Prepare, review and distribute regulatory documents for compliance.
• Track and manage regulatory submissions, ethics, ICFs, and CTAs.
• Support contract negotiations and timelines.
• Maintain records in internal systems and monitor milestones.
• Provide regulatory expertise to project teams and SAMs.
• Collaborate with sponsors and cross-functional teams to start studies.

Skills

Site Activation

Regulatory submissions

Contract negotiations

Start-up activities

Polish fluency

English communication

Project planning

Stakeholder management

Education

Bachelor’s Degree in Life Sciences

Job description

IQVIA in Poland is seeking a Senior RSU Specialist to join our FSP team. This home-based role requires deep knowledge of local regulatory requirements, site activation processes, and contract negotiations.

Fluency in Polish with strong English communication is essential. You will coordinate regulatory submissions, ethics submissions, ICFs, CTAs, and other essential documents, acting as the main contact for sites, Site Activation Managers, and project teams while ensuring timelines and quality.