PSI CRO AG

Full-stack Engineer

• Architect, develop and maintain business applications
• Process user requests for developing of new and support for existing IT systems
• Prepare documentation related to development and maintenance of business applications
• Execute and implement software tests, participate in code reviews
• Follow the development standards applied within the department
• Track the development, maintenance and related tasks in the tracking system used within the team
• Follow the progress of systems development technologies and advance professional skills as necessary

Full Stack Developer – AI Solutions

DevOps Engineer

• Troubleshoot system issues using logs, diagnostics, and monitoring tools
• Develop and maintain automation scripts using PowerShell and Bash
• Design and manage CI/CD pipelines for continuous integration and deployment
• Configure and maintain web servers (IIS) and support application hosting environments
• Deploy, manage, and scale applications in Azure Kubernetes Service (AKS)
• Build and maintain Docker images, Docker files, and containerized environments
• Implement and maintain monitoring, logging, and observability solutions (Grafana, Prometheus, ELK, etc.)
• Collaborate with development teams to ensure smooth release cycles and reliable deployments
• Contribute to improving system architecture and adopting best DevOps practices

Research Analyst

• Coordinates investigator/ site feasibility and identification process, as well as study startup.
• Monitors project timelines and patient enrollment, implements respective corrective and preventive measures.
• Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region.
• Manages Monitors in the query resolution process, including Central Monitoring observations.
• Coordinates safety information flow and protocol/process deviation reporting.
• Performs clinical supplies management with vendors on a country and regional level.
• Ensures study-specific and corporate tracking systems are updated in a timely manner.
• Acts as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/ Project Manager.
• Coordinates planning of supervised monitoring visits and conducts the visits.
• Manages the project team in site contracting and payments.
• Leads project team calls on a country level as well as provides status updates and reports to Regional Lead/ Project Manager.
• Ensures ongoing evaluation of data integrity and compliance at a country/regional level.
• Conducts site audit preparation visits, may participate in site audits, and coordinates resolution of site audit findings on a country/regional level.
• Oversees project team in CAPA development and implementation.
• Coordinates project team in process deviations review, management and reporting.
• Conducts initial training and authorization monitoring visits for Monitors and acts as a mentor for newly promoted Lead CRAs.
• Provides project-specific training and prepares training materials for the project team under supervision of a Project Manager and Regional Project Lead.
• Delivers trainings and presentations at Investigator Meetings.
• Prepares, conducts and reports site selection, initiation, routine monitoring and closeout visits.
• Ensures that subject recruitment targets and project timelines are properly defined, communicated, recorded, and met at site level.
• Ensures accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations.
• Supervises source data verification and follows up on data queries at site level in the country/region; reviews and manages study risks on a site level.
• Ensures proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on a country/region level.
• Reviews essential study documents and supervises reconciliation of study Investigator Site File (ISF) / TMF at site level and country/region level.
• Ensures data integrity and compliance at a site level.
• Supervises Site Management Associates in the flow of documents and laboratory supplies between the site and the Central/ Regional Lab/ Central Reviewer.
• Conducts project-specific training of site Investigators.
• Supports preparation of draft regulatory and ethics committee submission packages.

Lead Clinical Research Associate

• As a Senior CRA, you will work on the frontline of communication with project stakeholders, ensuring timelines, targets and standards of clinical research projects in a variety of therapeutic indications.
• You will build and maintain relationships with clinical sites and investigators.
• Your focus will be on subjects’ rights, safety and well-being and quality of data compliance.
• Responsibilities will include conducting and reporting all types of onsite monitoring visits, driving the study startup phase, performing CRF reviews, source document verification and query resolution.

Senior Clinical Research Associate

• Participate in the identification of opportunities for AI-driven automation and process optimization
• Architecture, develop, and implement AI/ML solutions for Clinical Data Management and operational processes using LLMs, RAG, traditional ML techniques, and rule-based approaches
• Define and execute strategies for model development, testing, validation, benchmarking, and training data preparation
• Integrate AI solutions into existing desktop and web-based software platforms (primarily C#/.NET applications)
• Collaborate with cross-functional stakeholders to ensure alignment with regulatory, quality, and operational requirements
• Prepare and maintain technical documentation related to software applications, AI models, and development processes
• Stay current with advancements in AI, machine learning, and software engineering technologies, and proactively evaluate their applicability within the organization

Full Stack Developer – AI Solutions

DevOps Engineer

DevOps Engineer

Lead Clinical Research Associate

Senior Clinical Research Associate

Lead Software Developer, AI Solutions