RWE Site Manager with SSU Experience

Job Title:RWE Site Manager with SSU Experience
Location:Poland; Home-Based

Job Overview:
As an RWE Site Manager 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 ICF country adaptation regulatory/ethics submission packages and obtaining necessary approvals; including preparation and management of Essential Document Packages (EDPs)ensuring sites meet all requirements for initiation and activation.
• Performs as needed initiation monitoring and close out visits remotely and in accordance with contracted scope of work.
• Serves as primary contact between the business and the investigator site including remote review of Case report Form (CRF) data timely transmission of clinical data from assigned studies works with sites on query resolution and final data review; and ensures proper documentation of site management communications.
• 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. Learn more at

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements misrepresentations or material omissions during the recruitment process will result in immediate disqualification of your application or termination of employment if discovered later in accordance with applicable law. We appreciate your honesty and professionalism.