PSI CRO AG

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

Compliance

• Focus on compliance matters related to in-house IT systems and processes
• Work with documents to ensure standards, industry requirements, and policies are met
• Create, update and process internal IT documents (change control, risk assessment, validation, etc.)
• Generate IT documentation for audits
• Participate in IT interviews during audits
• Provide answers to IT questions from sponsors
• Follow up on resolution of audit findings
• Support development and update of IT-related documents
• Monitor and ensure compliance with relevant laws and standards
• Participate in regular risk assessments

IT Compliance Specialist

Analyst

• Implement, manage and improve our compensation and benefits programs
• Oversee the day-to-day analysis, execution, and communication of global pay and benefits
• Define a fair, equitable and competitive total compensation and benefits package
• Develop a consistent compensation philosophy in line with work culture
• Utilize various methods and techniques for data-based decisions on compensation plans
• Support the Training & Resourcing team with recruitment and talent management
• Support the Finance team with budgets and financial analysis
• Support Legal team to ensure compliance of compensation and benefit programs
• Participate in salary and labor market surveys
• Conduct ongoing research on emerging trends and best practices
• Assess competitors' compensation and benefits plans and make recommendations
• Provide subject matter expertise to key stakeholders

Senior Compensation Analyst – Fixed-term Contract

• Focus on compliance matters related to in-house IT systems and processes
• Work with documents to ensure compliance with standards and policies
• Create, update and process internal IT documents
• Generate and provide IT documentation for audits
• Participate in IT interviews during internal and external audits
• Answer IT questions from sponsors and reviews of agreements
• Follow up on resolution of audit findings
• Support development and update of IT-related documents
• Monitor and ensure compliance with relevant laws, regulations, and standards

Business Development Rep

• Identify and recruit new clinical trial sites for the Milestone One network
• Promote Milestone One’s brand and attract new clients
• Develop and maintain a patient referral network
• Define strategy and manage communication with sites and Sponsors
• Oversee site management from identification to contract finalization
• Implement development plans for clinical sites
• Collect and review feedback from sites through evaluation reports

Clinical Business Development Manager

Research Analyst

• Conduct and report all types of onsite monitoring visits across sites in Portugal
• Be involved in study startup
• Perform CRF review, source document verification and query resolution
• Be responsible for site communication and management
• Be a point of contact for in-house support services and vendors
• Communicate with internal project teams regarding study progress
• Be involved in site identification process
• Support regulatory team in preparing documents for study submissions
• Prepare for and participate in audits and inspections

Clinical Research Associate II

• Responsible for active promotion of Milestone One brand
• Acquire new clinics and build a site network
• Manage Clinical Trials from vendor selection through site contracting
• Collaborate closely with Operations team, site personnel, and external CRO partners
• Identify and recruit new clinical trial sites for the Milestone One network
• Promote Milestone One’s brand and attract new clients by organizing and attending industry events
• Develop and maintain a patient referral network
• Define strategy and manage communication with sites and Sponsors
• Oversee site management from identification to contract finalization
• Lead sites identification, evaluation, selection, and oversight processes
• Implement development plans for clinical sites
• Collect and review feedback from sites through evaluation reports

Business Development Manager

Data Scientist

• Responsible for all data management activities in large, complex studies
• Primary communication point for project teams and company departments regarding clinical data management
• Co-ordinate/perform user acceptance testing
• Development of Data Validation Plan/Edit Check Specifications
• Data validation and query generation
• Coordination of processing, dispatch and archiving of CRFs/queries
• Preparation and attendance at audits/inspections of Data Management
• Training of Assistant Data Managers and clinical team regarding CRF completion

Lead Data Manager – Clinical Trials

• Acts as a communication line for project teams regarding clinical data management
• Maintains TMF/eTMF
• Trains Assistant Data Manager
• Is involved in clinical data management activities including, but not limited to: Supporting development of study documentation (eCRF Requirements, Edit Checks Specification, Data Management Plan, CRF Completion Guidelines, User Access Management Plan, Data Validation Plan, External Data Transfer Agreements, SAE Reconciliation Guidelines, Local Lab Normal Ranges Guidelines, Coding Guidelines where applicable)
• User acceptance testing
• User access management
• Data review eCRF/External data reconciliation
• Medical coding (for staff with medical/Life Science background)
• Supporting SAE reconciliation
• Query management
• Local lab normal ranges entry and QC
• Study Database Lock activities
• Archival of CRFs
• QC Data entry/QC
• Project status reporting
• Data listings/Patient profiles generation and delivery
• Assisting with Database Lock tasks as needed for assigned projects

Data Manager – Clinical Trials

Project Manager

• Manages medium-sized (5-15 countries and/or full service) or large (>15 countries, full service) projects/programs under general supervision
• Leads project teams
• Performs project supervision of small (<5 countries and/or limited services) projects/programs
• Supervises the production of project deliverables in conformance with the predefined quality standards, on time and on budget
• Acts as a primary escalation contact for PSI customers, vendors, project teams, and representatives of other functional areas for all project-related issues
• Trains, mentors and coaches Regional Project Leads and Project Managers in the department
• Participates in feasibility research
• Supports business development tasks, such as development of proposals, client presentations, bid defense meetings, and the like

Senior Project Manager

• Act as the main line of communication between the project team, sponsor, and the site
• Build and maintain a good relationship with the site staff involved in the study conduct
• Prepare, conduct, and report site selection, initiation, routine monitoring and close-out visits
• Ensure that subject recruitment targets are timely defined, communicated, recorded and met, and project timelines are followed at site level
• Ensure accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations
• Perform source data verification and follows up on data queries at site level; review and manage study risks on a site level
• Ensure proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on sites
• Review essential study documents and reconcile study Investigator Site File (ISF) / TMF at site level
• Ensures quality (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
• Ensure the flow of documents and study supplies between the project team, site and the Central/ Regional Laboratory/ Central Reviewer/ Warehouse
• Conduct project-specific training of site investigators
• Support preparation of Investigator newsletters
• Assist Site Management Associates in maintaining study-specific and corporate tracking systems at site level
• 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
• Be involved in study startup (if applicable)
• Perform CRF review, source document verification and query resolution
• Be responsible for site communication and management
• Supervise study activities, timelines, and schedules on the country level
• Be a point of contact for in-house support services and vendors
• Be involved in quality control, such as compliance monitoring and reports review
• Participate in feasibility research
• Support regulatory team in preparing documents for study submissions

Senior Clinical Research Associate

• Hold a leadership role within the study team, overseeing and guiding the clinical team while driving trial activities at a country or regional level.
• Ensure high-quality execution, compliance, and timely delivery.
• Act as a key point of coordination across cross-functional teams.
• Focus on leadership, mentorship, oversight, and consistency in monitoring practices rather than direct site management, with minimal to no site assignments and a low-travel model.
• Monitors project timelines, patient enrollment, data cleaning, and ensuring compliance while implementing respective corrective and preventive measures.
• Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region.
• Acts as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/ Project Manager.
• Leads project team calls on a country level as well as provides status updates and reports to Regional Lead/ Project Manager.
• Provides project-specific training and prepares training materials for the project team under supervision of a Project Manager and Regional Project Lead.
• 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.
• Collaborates with investigator/ site feasibility and identification process, as well as study startup.
• 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.
• Coordinates planning of supervised monitoring visits and conducts the visits.
• Manages the project team in site contracting and payments.
• 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.
• Delivers trainings and presentations at Investigator Meetings.
• 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 Site Management Associates in the flow of documents and laboratory supplies between the site and the Central/ Regional Lab/ Central Reviewer.
• Supports preparation of draft regulatory and ethics committee submission packages.

Lead Clinical Research Associate

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

DevOps Engineer

IT Compliance Specialist

Senior Compensation Analyst – Fixed-term Contract

IT Compliance Specialist

Clinical Business Development Manager

Clinical Research Associate II

Business Development Manager

Lead Data Manager – Clinical Trials

Data Manager – Clinical Trials

Senior Project Manager

Clinical Research Associate II

Senior Clinical Research Associate

Lead Clinical Research Associate

Full Stack Developer, AI Solutions

DevOps Engineer