Remote Poland-Based RWE Site Manager (SSU & Ethics)

IQVIA; Warszawa; On-site; PLN 151,000 - 280,000; Full time

Job summary

IQVIA is seeking an RWE Site Manager 2 with SSU experience to drive ethics submissions and contract negotiations with study sites from Poland, home-based. The role emphasizes regulatory expertise, cross-functional collaboration, and central monitoring development.

Requirements include fluency in Polish and English, with German or Romanian an advantage; prior RWE or clinical trial exposure is essential to ensure compliance and operational efficiency.

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 the regulatory landscape and experience in RWE or regular clinical trials.
• Willingness to learn central monitoring and start this experience in the role.

Responsibilities

• Perform site identification and selection activities including collecting Site Information Forms (SIF) and Confidentiality Disclosure Agreements (CDA) and tracking and filing these documents.
• Conduct Site Selection Visits (SSVs) as needed.
• Manage study start-up activities including preparing regulatory/ethics submission packages and obtaining necessary approvals.
• Collect, review and file site regulatory documents ensuring completeness and accuracy.
• Prepare review and negotiate site contracts and budgets with investigator sites.
• Collaborate with cross-functional teams to support site management and centralized monitoring.
• Review and agree on project planning and timelines.

Skills

Study start-up

Ethics submissions

Contract negotiations

Polish language

English language

Regulatory landscape knowledge

Central monitoring

Job description

IQVIA is seeking an RWE Site Manager 2 with SSU experience to drive ethics submissions and contract negotiations with study sites from Poland, home-based. The role emphasizes regulatory expertise, cross-functional collaboration, and central monitoring development.

Requirements include fluency in Polish and English, with German or Romanian an advantage; prior RWE or clinical trial exposure is essential to ensure compliance and operational efficiency.