PSI CRO AG

Contract Specialist

• Facilitate negotiations of site agreements and budgets to align with the site activation plan
• Customize and prepare country- and site-specific agreements and organize translations
• Track the status of site agreement and budget negotiations
• Prepare executable versions of site agreements and budgets
• Coordinate the signature process
• File executed site agreements in the Trial Master File
• Update all concerned functions on the site contracting process

Site Contract Specialist I

Business Development Rep

• Actively promote the Milestone One brand
• Acquire new clinics and build the Milestone One site network
• Manage clinical trials from vendor selection through site contracting
• Identify and recruit new clinical trial sites through market research, direct outreach, and industry contacts
• Promote the brand and attract new clients through industry events, marketing campaigns, and strategic partnerships
• Develop and maintain patient referral networks with physicians, clinics, and healthcare stakeholders
• Define strategy and manage communication with sites and sponsors
• Oversee site management from identification to contract finalization
• Lead site identification, evaluation, selection, and oversight processes
• Implement development plans for clinical sites, including tools, training, and performance monitoring
• Collect and review site feedback through evaluation reports
• Collaborate with Operations, site personnel, and external CRO partners to drive successful trial execution

Clinical Business Development Manager

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
• Support and participate in audits and inspections

Clinical Research Associate

Marketing

• Plan and execute assigned marketing campaigns, including email, social, paid ads, content, PR, and internal communication
• Create content for assigned channels
• Track performance metrics and produce reports for stakeholders
• Analyze campaign performance and optimize tactics
• Manage relationships with marketing vendors
• Manage budgets and billing for assigned channels
• Perform updates of the PSI website
• Plan and support PSI events with the global marketing events team
• Contribute to PSI marketing strategy
• Mentor junior members of the marketing team

Senior Marketing Specialist

Referral Specialist

• Build and manage a country-specific network of referring physicians across various therapeutic areas
• Identify and select physicians
• Provide physicians with training and support throughout the referral process
• Plan and conduct regular visits to referring physicians in person and/or via video conference
• Promote collaboration between referring physicians and study investigators
• Document key discussions and objectives in reports
• Provide ongoing support to referring physicians and their teams
• Ensure agreed-upon tasks are executed accurately and efficiently
• Collaborate with Clinical Operations, Regulatory, and Legal departments to implement the referral process across projects

• Build and manage a country-specific network of referring physicians across various therapeutic areas
• Ensure a smooth and effective referral process between referring physicians and study investigators
• Identify and select physicians
• Provide physicians with training and support throughout the referral process
• Plan and conduct regular visits to referring physicians in person and/or via video conference
• Document key discussions and objectives in reports
• Provide ongoing support to referring physicians and their teams
• Ensure agreed-upon tasks are executed accurately and efficiently
• Collaborate with Clinical Operations, Regulatory, and Legal departments to implement the referral process across projects

• Manage all data management activities in large, complex clinical studies under general supervision
• Perform data management activities for small to medium-sized projects under minimal supervision
• Serve as the primary communication point for project teams and company departments regarding clinical data management
• Communicate with clients and vendors regarding data management aspects and reporting
• Coordinate EDC development, data collection, cleaning, reconciliation, database lock, final integrated database development, and final data management deliverables
• Review study documents and develop or review data management plans and project-specific guidelines
• Coordinate or perform user acceptance testing
• Develop data validation plans and edit check specifications
• Coordinate and supervise data entry and provide feedback on data quality
• Perform automatic and manual data validation, discrepancy review and resolution, and query generation and resolution
• Handle non-CRF electronic data, including receiving, archiving, loading, review, and reconciliation
• Perform database edits and manual CRF review
• Coordinate clinical database lock and CRF/query processing, dispatch, and archiving
• Provide input into CRF and data collection form design and review CRFs for accuracy and protocol adherence
• Code medical data and review coding dictionaries and listings where applicable
• Perform SAE reconciliation and review electronic data transfer specifications
• Liaise with the Document Center regarding TMF and eTMF maintenance
• Perform and document database quality-control checks
• Support internal, client, and third-party audits and resolve Data Management audit findings
• Train Assistant Data Managers and provide project-specific training to investigators and clinical teams
• Prepare for and attend investigator meetings, client/vendor meetings, and teleconferences

Lead Data Manager – Clinical Trials

Full-stack 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 professional skills
• Develop and support desktop WinForm/Blazor hybrid applications for internal clients and PSI business processes

Full Stack .NET Developer

• 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 professional skills
• Work on desktop WinForm/Blazor hybrid applications for internal clients

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
• Continuously advance professional skills
• Develop projects for internal clients to support PSI business processes and operations
• Work on desktop WinForms/Blazor hybrid applications, contributing to new development and ongoing support

Fullstack .Net Developer

• Architect, develop, and maintain business applications across multiple projects
• Process user requests for new features
• Provide support for existing IT systems
• Prepare documentation related to application development and maintenance
• Execute and implement software tests
• Participate in code reviews
• Follow department development standards
• Track development, maintenance, and related tasks in the team’s tracking system
• Stay current with evolving system development technologies
• Continuously advance professional skills
• Develop projects for internal clients to support PSI business processes and operations
• Work on desktop WinForm/Blazor hybrid applications, including new development and ongoing support

• 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
• Coordinate documents and study supplies between project team, site, laboratories, reviewers, and warehouse
• Conduct project-specific training of site investigators
• Support preparation of Investigator newsletters
• Assist Site Management Associates with study-specific and corporate tracking systems
• Support preparation of 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

Clinical Research Associate II

Associate

• Serve as the main site contact for non-trial-participant and non-protocol-related issues, including vendors, trial supplies, and access management
• Manage records flow with sites and off-site facilities
• Prepare regulatory and ethics committee submission/notification documents and records
• Coordinate payments to sites and off-site facilities
• Prepare for and follow up on site audits and inspections
• Review and coordinate site-specific query resolution with Monitors and sites
• Review site-specific EDC completion progress and provide regular updates to the Monitor
• Serve as the main contact point for other company departments on administrative site-related issues
• Organize, participate in, and prepare reports of internal project team meetings
• Collaborate with sites and the project team on Investigator Meetings' organization
• Provide, under supervision, on-the-job coaching to Site Management Associates I & II and Clinical Operations Administrative Support staff
• Arrange and track initial and ongoing trial training for investigator site teams in vendor-related systems
• Provide training in courier management and trial supplies ordering to investigator sites
• File trial records in the TMF and perform regular TMF checks at site and country level
• Participate in and follow up on TMF and systems audits
• Prepare, distribute, and update Investigator Site Files and ISF checklists
• Coordinate translation of trial records at site and country level
• Collect IP-REDs and compile IP-RED packages for further review
• Serve as the main vendor contact for non-trial-participant-related issues, including pre-trial testing of vendor systems
• Track vendor-related supplies at site, country, and regional levels
• Exchange information and records with vendors

Senior Site Management Associate

Infrastructure Engineer

• 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 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 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

Site Contract Specialist I

Clinical Business Development Manager

Clinical Research Associate

Senior Marketing Specialist

Referral Specialist

Referral Specialist

Lead Data Manager – Clinical Trials

Full Stack .NET Developer

Full Stack .NET Developer

Fullstack .Net Developer

Full Stack .NET Developer

Clinical Research Associate II

Senior Site Management Associate

IT Infrastructure Engineer – Windows, Active Directory, VMware

IT Infrastructure Engineer, Windows, Active Directory, VMware