RWE Site Manager with SSU Experience

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

Job Title: RWE Site Manager 2 with SSU Experience

Location: Poland; Home-Based

Job Overview

As an RWE Site Manager 2 you will play a pivotal role in the study start-up process focusing on ethics committee submissions and contract negotiations with sites. You will collaborate with cross-functional teams to support site management and centralized monitoring. Your expertise in the regulatory landscape coupled with your experience in RWE or regular clinical trials will be crucial in ensuring compliance and operational efficiency. Proficiency in Polish and English is required with German or Romanian being a significant advantage.

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.

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.
• Central monitoring experience is nice to have with a willingness to learn and start this experience in the role.

Disclaimer

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties responsibilities and qualifications required of employees assigned to this job. At IQVIA we believe that diversity inclusion and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone everywhere. When our talented employees bring their authentic selves and their diverse experiences to work they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

The potential base pay range for this role, when annualized, is 150 800,00 zł - 280 000,00 zł. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.