PSI CRO AG

Infrastructure Engineer

• Design, implement, maintain, and improve Windows and Linux server infrastructure
• Manage and maintain virtualization, storage, and backup platforms
• Administer Windows Active Directory and Public Key Infrastructure (PKI)
• Support enterprise applications and services hosted on Windows and Linux platforms, including email and business systems
• Manage infrastructure management and supporting systems, including monitoring, patch management, configuration management, and access control services
• Plan and execute OS patching and infrastructure upgrades in accordance with company policies
• Lead small and medium-sized infrastructure projects and participate in larger infrastructure initiatives
• Perform qualification, validation, troubleshooting, and performance optimization of infrastructure systems
• Maintain accurate infrastructure asset inventory, warranties, and related services
• Coordinate with infrastructure vendors, including tracking deliveries, contract execution, and vendor activities
• Develop and maintain technical documentation, procedures, and system standards
• Collaborate with Network & Connectivity and Cloud & Modern Workplace teams on cross-domain initiatives

IT Infrastructure Engineer – Windows, Active Directory, VMware

• Design, implement, maintain, and continuously improve Windows and Linux server infrastructure
• Manage and maintain virtualization, storage, and backup platforms
• Administer Windows Active Directory and Public Key Infrastructure (PKI)
• Support enterprise applications and services hosted on Windows and Linux platforms, including email and business systems
• Manage monitoring, patch management, configuration management, and access control services
• Plan and execute OS patching and infrastructure upgrades according to company policies
• Lead small and medium-sized infrastructure projects and participate in larger infrastructure initiatives
• Perform qualification, validation, troubleshooting, and performance optimization of infrastructure systems
• Maintain accurate infrastructure asset inventory, warranties, and related services
• Coordinate with infrastructure vendors, including deliveries, contract execution, and vendor activities
• Develop and maintain technical documentation, procedures, and system standards
• Collaborate with Network & Connectivity and Cloud & Modern Workplace teams on cross-domain initiatives

IT Infrastructure Engineer, Windows, Active Directory, VMware

General

• Drive successful delivery of clinical trials across multiple countries
• Partner with Project Managers, CRAs, sponsors, and cross-functional teams
• Plan, implement, and manage projects in compliance with industry regulations, ICH-GCP, essential study documents, and controlled documents
• Act as primary or secondary project management contact for project teams and PSI support services in designated countries
• Review study status and report progress
• Collect and report project status updates for designated regions
• Develop and update project planning documents, essential study documents, and project manuals/instructions
• Manage and report KPIs for designated countries and clinical project team members
• Ensure project timelines and subject enrollment targets are met
• Coordinate study-specific and corporate tracking systems
• Coordinate site contractual startup and budget negotiations
• Establish project-team communication lines and supervise clinical project team performance
• Identify, escalate, and resolve resourcing and performance issues
• Conduct or supervise therapeutic-area training
• Prepare presentations and conduct Investigator training
• Ensure compliance with project-specific training matrices
• Conduct field training of Monitors
• Supervise site selection, site initiation, monitoring, and closeout visits
• Oversee investigator and site payments, CRF data retrieval/upload, monitoring, and query resolution
• Supervise preparation for study audits/inspections and resolution of findings
• Coordinate monitoring visits and review site visit reports
• Coordinate Regulatory and Ethics Committee submissions and notifications
• Oversee safety information flow and participate in feasibility research
• Review/approve project expenses and timesheets when delegated

Regional Project Lead

Associate

• Serve as the main point of contact between site personnel and CRA involved in the project, helping with query resolution and EDC completion
• Serve as the primary sites’ contact point for vendors, study supplies, and access management
• Ensure completion of pre-study testing of local site facilities, including scans, MRI/CT qualification questionnaires, and test ECGs
• Assist Monitors with prompt completion of subject event and site event information in CTMS
• Track resolution status of site issues and action items in CTMS
• Manage ordering, receipt, inventory storage, distribution, return/recall, and reconciliation of clinical supplies
• Ensure regulatory and ethics committee submissions and notifications, staying current with local regulations and dispositions
• Coordinate preparation for and follow-up on site, TMF, and systems audits and inspections
• Manage the TMF at site and country level and regularly file documents
• Prepare, distribute, and update Investigator Site Files (ISF) and ISF checklists
• Arrange and track initial and ongoing project training for site teams in vendor-related systems
• Review document management and translation status of the study
• Ensure proper safety information flow with investigative sites

Site Management Associate I

Clinical Research

• Conduct and report all types of onsite monitoring visits
• Be involved in study startup
• Perform CRF review, source document verification and query resolution
• Be responsible for site communication and management
• Serve as a point of contact for in-house support services and vendors
• Communicate with internal project teams regarding study progress
• Participate in feasibility research
• Support the regulatory team in preparing documents for study submissions
• Work on clinical studies across different therapeutic indications while maintaining high quality standards

Clinical Research Associate II

• Conduct and report all types of onsite monitoring visits
• Perform CRF reviews, source document verification and query resolution
• Manage site communication
• Supervise study activities, timelines and schedules for each site
• Act as a point of contact for in-house support services and vendors
• Support quality control, including compliance monitoring and report review
• Build and maintain relationships with clinical sites and investigators
• Ensure subjects’ rights, safety and well-being and quality of data compliance

Senior Clinical Research Associate

• Design, implement, maintain, and continuously improve infrastructure systems supporting PSI’s global business operations
• Design, implement, maintain, and improve Windows and Linux server infrastructure
• Manage and maintain virtualization, storage, and backup platforms
• Administer Windows Active Directory and Public Key Infrastructure (PKI)
• Support enterprise applications and services hosted on Windows and Linux platforms, including email and business systems
• Manage monitoring, patch management, configuration management, and access control services
• Plan and execute OS patching and infrastructure upgrades according to company policies
• Lead small and medium-sized infrastructure projects and participate in larger infrastructure initiatives
• Perform qualification, validation, troubleshooting, and performance optimization of infrastructure systems
• Maintain accurate infrastructure asset inventory, warranties, and related services
• Coordinate with infrastructure vendors, including tracking deliveries, contract execution, and vendor activities
• Develop and maintain technical documentation, procedures, and system standards
• Collaborate with Network & Connectivity and Cloud & Modern Workplace teams on cross-domain initiatives

• Act as the main line of communication between the project team, sponsor, and the site
• Build and maintain relationships with site staff involved in study conduct
• Prepare, conduct, and report site selection, initiation, routine monitoring, and close-out visits
• Define, communicate, record, and meet subject recruitment targets and follow project timelines at site level
• Ensure accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations
• Perform source data verification and follow up on data queries at site level
• Review and manage study risks at site level
• Ensure proper handling, accountability, reconciliation, and return of Investigational Products and clinical study supplies
• Review essential study documents and reconcile Investigator Site File / TMF at site level
• Ensure data integrity and compliance at site level
• Conduct site audit preparation visits and resolve site audit findings
• Participate in study site audits and client onsite visits as required
• Manage the flow of documents and study supplies between project teams, sites, laboratories, reviewers, and warehouses
• Conduct project-specific training of site investigators
• Support preparation of Investigator newsletters
• Assist Site Management Associates in maintaining study-specific and corporate tracking systems
• Support preparation of draft regulatory and ethics committee submission packages
• Support collection of IP-RED packages at site/country level
• Facilitate review and reconciliation of the study TMF on country and site levels

• Conduct and report all types of onsite monitoring visits
• Perform CRF reviews, source document verification and query resolution
• Manage site communication
• Manage sites
• Supervise study activities, timelines, and schedules for each site
• Act as a point of contact for in-house support services and vendors
• Support quality control, including compliance monitoring and report review
• Build and maintain relationships with clinical sites and investigators
• Ensure subjects’ rights, safety and well-being and quality of data compliance

Freelance Senior Clinical Research Associate

• Maintain databases and tracking systems
• Compile, procure, process, translate and file large volumes of documents
• Communicate with company departments and external parties
• Serve as the communication point for investigative sites participating in clinical research projects
• Coordinate site-specific query resolution, project training and access to vendor-related systems for site teams
• Receive and route all mail and incoming calls
• Assist with meeting arrangements
• Prepare draft agendas and minutes for project meetings

Site Management Associate

• Conduct and report all types of onsite monitoring visits
• Perform CRF review, source document verification and query resolution
• Be responsible for site communication and management
• Act as a point of contact for in-house support services and vendors
• Communicate with internal project teams regarding study progress
• Participate in feasibility research
• Support the regulatory team in preparing documents for study submissions

Contract Clinical Research Associate

Manager

• Lead and facilitate initial and ongoing study Risk Management
• Participate in selection and setup of the RBM platform
• Perform Centralized Monitoring for a study, including review of Key Risk Indicators, Statistical Analyses and Quality Tolerance Limits
• Present Centralized Monitoring analysis results to study teams and clients
• Manage issues in a cross-functional environment
• Develop and review study-specific Plans
• Set up and manage targeted SDV and monitoring strategy for a study
• Set up and manage Central Data Review activities in a study
• Contribute to Proposals and bid defense meetings with information about Risk Based Monitoring services
• Communicate study challenges to the Clinical Data Science group and work out data-driven solutions

IT Infrastructure Engineer – Windows, Active Directory, VMware

IT Infrastructure Engineer – Windows, Active Directory, VMware

IT Infrastructure Engineer, Windows, Active Directory, VMware

Regional Project Lead

Site Management Associate I

Clinical Research Associate II

Senior Clinical Research Associate

IT Infrastructure Engineer – Windows, Active Directory, VMware

Clinical Research Associate II

Freelance Senior Clinical Research Associate

Site Management Associate

Contract Clinical Research Associate

Central Monitoring Manager