PSI CRO AG

Clinical Research

• Works within the feasibility department in leading research efforts for new business opportunities and data analytic strategies.
• Assesses key study elements that impact investigator interest and patient enrollment.
• Reviews scientific literature, industry benchmarking, competition and treatment landscape, epidemiology, PSI historical data, and standards of care.
• Develops blinded feasibility questionnaire based on key enrollment drivers and manages the outreach process.
• Develops protocol-specific questions for PSI Scientific Advisory Board review.
• Completes protocol comparison.
• Builds country ranking tables based on key study criteria.
• Models enrollment scenarios for dose escalation and expansion studies within PSI Study Modeling tool, VISIONAL.
• Develops slides for Bid Defense Meetings (BDM).
• Leads data analytic strategies and integration with CTMS/Site Identification Module.
• Supports local country site outreach efforts for new business opportunities and awarded studies.
• Conducts trainings of PSI staff.

Senior Clinical Trial Specialist

Compliance

• Focus on compliance matters related to in-house IT systems and processes
• Work with documents to ensure PSI meets standards, industry requirements, and internal policies
• Create, update and process internal IT documents (change control, risk assessment, computer system inventory, validation, disaster recovery plan)
• Generate and provide IT documentation for internal and external audits
• Take part in IT interviews during internal and external audits
• Provide answers to IT questions from sponsors
• Follow up on resolution of audit findings related to IT compliance
• Support development and update of IT-related documents
• Participate in the development of departmental QSDs
• Monitor and ensure compliance with PSI QSDs, relevant laws, regulations and standards
• Participate in regular risk assessments to identify potential vulnerabilities in IT systems and processes

IT Compliance Specialist

Medical writer

• Writes, edits, and reviews documents, including informed consent forms, patient information, and other project-specific clinical documentation
• Writes, edits, reviews, finalizes, and tracks clinical study report (CSR) patient safety narratives
• Collects and tracks documents for CSR appendices, in support of the Quality Control Associates
• Performs quality control (QC) reviews of PSI-developed documents, in support of the Quality Control Associates
• Acts as a backup contact for the Project Managers and other PSI functional areas within the scope of assigned medical writing tasks
• Collaborates with the Process Improvement narrative automation team to develop patient safety narratives

Associate Medical Writer

Backend Engineer

• Architect, develop, and maintain business applications across multiple projects
• Process user requests for new features and provide support for existing IT systems
• Prepare documentation related to development and maintenance of applications
• Execute and implement software tests, participate in code reviews
• Follow the development standards applied within the department
• Track development, maintenance, and related tasks in the team’s tracking system
• Stay up to date with evolving system development technologies and continuously advance your professional skills

Full Stack .NET Developer

Clinical Operations

• Take end-to-end operational responsibility for clinical research projects within the assigned region.
• Ensure effective execution of clinical trials in line with study protocols, timelines, quality standards, and regulatory requirements.
• Oversee site qualification process and ensure smooth study start-up, including site contracting support, site activation, and coordination with internal and external stakeholders.
• Lead, manage, and support regional teams of operational and BD staff.
• Act as a mentor and escalation point for coordinators facing operational challenges.
• Proactively manage risks, troubleshoot operational bottlenecks, and lead local resolution
• Collaborate closely with internal global teams to ensure alignment, clear communication, and seamless project execution.
• Monitor operational KPIs, prepare progress reports, and implement corrective actions where needed.
• Represent Milestone One in operational discussions with sponsors, partners, and at selected industry meetings.

PSI CRO AG

Senior Clinical Trial Specialist

IT Compliance Specialist

Associate Medical Writer

Full Stack .NET Developer

Regional Clinical Operations Manager

Full Stack .NET Developer

Full Stack .NET Developer

Fullstack .Net Developer