Remote RWE Site Manager – SSU & Contracts

IQVIA; Warszawa; On-site; PLN 123,000 - 280,000; Full time

Job summary

IQVIA is seeking an RWE Site Manager with SSU experience to lead study start-up activities in Poland (home-based). You will focus on ethics committee submissions, contract negotiations with sites, and cross-functional collaboration to support site management and centralized monitoring.

The role requires proficiency in Polish and English (German or Romanian a plus) and a strong knowledge of regulatory requirements. You will manage regulatory packages, SIFs/CDAs, site contracts, and timelines.

Qualifications

• Experience in study start-up ethics committee submissions and contract negotiations.
• Proficiency in Polish and English; German or Romanian is a plus.
• Knowledge of regulatory landscape and experience in RWE or regular clinical trials.
• Central monitoring experience is nice to have with a willingness to learn and start this experience in the role.

Responsibilities

• Identify and select sites, collect SIFs and CDAs, and track documents.
• Conduct Site Selection Visits as needed.
• Prepare regulatory/ethics submissions and Essential Document Packages (EDPs).
• Conduct initiation, monitoring and close-out visits per scope.
• Serve as primary contact between site and sponsor; review CRF data and ensure documentation.
• Review and negotiate site contracts and budgets.
• Collaborate with cross-functional teams on site management and centralized monitoring.
• Review project plans and timelines.

Skills

Study start-up submissions

Contract negotiations

Polish language

English language

Regulatory landscape knowledge

RWE/clinical trials experience

Central monitoring experience

Job description

IQVIA is seeking an RWE Site Manager with SSU experience to lead study start-up activities in Poland (home-based). You will focus on ethics committee submissions, contract negotiations with sites, and cross-functional collaboration to support site management and centralized monitoring.

The role requires proficiency in Polish and English (German or Romanian a plus) and a strong knowledge of regulatory requirements. You will manage regulatory packages, SIFs/CDAs, site contracts, and timelines.