PSI CRO AG

Business Development Rep

• Supports our Business Development team in building and expanding the network of clients
• Build and sustain long-lasting relationships with existing and potential clients (sponsors, CROs, medical institutions)
• Support Site Development Manager with active promotion of Milestone One brand by acquiring new clinics and building a site network
• Conduct research on potential clients to build extended network
• Set up meetings with potential clients to present MO1 business opportunities and benefits of cooperation with Milestone One
• Assist the Marketing team in preparation of promotional materials
• Attend medical/pharmaceutical conferences, and training workshops as required

Clinical Trials Business Development Representative

Chief Marketing Officer

• Builds, develops, and mentors Marketing team
• Participates in department resource allocation, workload evaluation, and utilization
• Participates in performance evaluation, facilitation of professional development and career advancement of Marketing staff
• Leads various marketing activities, including market research, content management, lead generation, brand management, customer engagement, advertising, digital marketing, and public relations
• Selects marketing vendors and oversees their performance
• Co-develops marketing strategies, encompassing both external marketing and internal communications
• Implements brand positioning, messaging, and visual identity across all channels
• Oversees various PSI events, including conferences
• Oversees lead generation programs
• Oversees promotion of PSI content
• Oversees digital marketing initiatives, including website optimization, SEO/SEM, email marketing, and social media
• Contributes to market research and competitive analysis to identify market trends, customer needs, and opportunities for differentiation

Marketing Director

• Builds, develops, and mentors Marketing team
• Participates in department resource allocation, workload evaluation, and utilization
• Participates in performance evaluation, facilitation of professional development and career advancement of Marketing staff
• Leads various marketing activities, including market research, content management, lead generation, brand management, customer engagement, advertising, digital marketing, and public relations
• Selects marketing vendors and oversees their performance
• Co-develops marketing strategies, encompassing both external marketing and internal communications
• Implements brand positioning, messaging, and visual identity across all channels
• Oversees various PSI events, including conferences
• Oversees lead generation programs
• Oversees promotion of PSI content
• Oversees digital marketing initiatives, including website optimization, SEO/SEM, email marketing, and social media
• Contributes to market research and competitive analysis to identify market trends, customer needs, and opportunities for differentiation.

Research Analyst

• Conduct and report all types of onsite monitoring visits as well as remote visits.
• Perform CRF review, source document verification and query resolution.
• Be responsible for site communication and management.
• Be involved in site identification process.
• Assist in training of less expert CRAs, depending on your level of experience.

Clinical Research Associate – Senior

Backend 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 .NET Developer, Blazor

• Training, mentoring and supervising study level responsibilities for Jr. CRAs
• Preparation, conduct, and reporting of selection, initiation, routine and closeout monitoring visits
• Delivering training of investigators, site staff and project teams
• Work with complex studies
• Perform CRF review, source document verification and query resolution
• Be responsible for site communication and management
• Be involved in site identification process
• Contact for clinical investigators, vendors and support services in regard to study progress
• Participate in feasibility research
• Preparation and delivering of presentations at Investigator’s Meetings
• Preparation for and attendance at company’s audits; resolution of audit findings
• Support to Regulatory Affairs in procurement of site regulatory documents
• Maintenance of study-specific automated tracking systems

Senior Clinical Research Associate

General Counsel

• Review, draft, and negotiate technology-related contracts (SaaS, cloud providers, AI solutions, etc.)
• Monitor and interpret emerging data regulations across jurisdictions (data protection & privacy laws, AI regulations, data localization requirements, etc.)
• Support compliance with NIS2 and other cybersecurity regulations
• Assist in the implementation of a contract management tool and AI solutions for Legal
• Contribute to the Data Governance project, particularly around data classification and retention schedules
• Work closely with PSI’s Legal, Data Protection, InfoSec, IT and business teams to align legal strategy with operational needs
• Stay abreast of legal developments in technology, data, and AI, and share insights with the broader Legal team

Legal Counsel

Operations

• Develop and maintain ontologies for various domains, ensuring accuracy and consistency
• Collaborate with cross-functional teams to identify and prioritize ontology needs
• Conduct research and analysis to identify relevant data sources and extract meaningful insights
• Design and implement ontology-based applications and tools to support data integration and analysis
• Evaluate and recommend ontology management tools and technologies
• Develop and maintain documentation and training materials for ontology users
• Collaborate with data scientists and engineers to ensure ontology alignment with data models and structures
• Conduct quality assurance checks to ensure ontology accuracy and completeness
• Continuously improve ontology development processes and methodologies

Associate, Process Improvement

Medical Reviewer

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CRO nº 1 em recrutamento de pacientes • Pesquisa Clínica • Ensaios Clínicos • Oncologia • Hematologia

PSI CRO AG é uma organização global de pesquisa por contrato (CRO) especializada na condução de ensaios clínicos. A empresa foca na entrega de ensaios clínicos pivotais de Fase 2 e Fase 3 em diversas áreas terapêuticas, incluindo Doenças Inflamatórias Intestinais, Oncologia, Hematologia, Doenças Infecciosas, Esclerose Múltipla e Doenças Raras. 

A PSI utiliza uma plataforma tecnológica proprietária para planejamento de ensaios clínicos e controle financeiro, garantindo que os estudos sejam conduzidos no prazo e dentro do orçamento. A empresa é reconhecida por sua expertise, qualidade, compatibilidade e confiabilidade, tendo sido premiada no CRO Leadership Awards por vários anos consecutivos. 

1001 - 5000 funcionários

Fundada em 1996

⚕️ Seguro de Saúde

💊 Farmacêutico

🔬 Ciência

Revisor de Dados Clínicos

1 minuto atrás

🇧🇷 Brasil – Remoto

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

🔍🏥 Revisor(a) Médico(a)

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Descrição

• Revisar dados e listagens clínicas de EDC, IxRS, Laboratório e outros fornecedores
• Identificar erros isolados e problemas sistemáticos relacionados ao desempenho do site
• Gerar, acompanhar e resolver queries de dados e problemas do site
• Identificar e registrar desvios de protocolo
• Auxiliar o Gerente de Monitoramento Central em atividades administrativas, incluindo gestão de dados do estudo, documentos e relatórios
• Garantir que os monitores de site recebam informações sobre riscos e problemas relacionados ao site. Escalar as constatações para as equipes do estudo
• Auxiliar na investigação da causa raiz e no acompanhamento de sinais de desempenho do site identificados durante a revisão de monitoramento central

🎯 Requisitos

• Graduação universitária ou combinação equivalente de educação, treinamento e experiência
• Experiência prévia em Pesquisa Clínica
• Experiência em monitoramento central e revisão de dados clínicos é um diferencial
• Proficiência profissional em inglês
• Domínio de aplicativos MS Office
• Perfil analítico e atenção aos detalhes
• Capacidade de aprender, planejar e trabalhar em um ambiente de equipe dinâmico

🏖️ Benefícios

• Oportunidades de desenvolvimento profissional

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Desenvolvido por Lior Neu-ner. Adoraria receber seu feedback — entre em contato por DM ou pelo e-mail support@remoterocketship.com
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Clinical Data Reviewer

• Review EDC, IxRS, Laboratory and other vendors’ data and clinical listings
• Identify single errors and systematic issues related to site performance
• Generate, follow up and resolves data queries and site issues
• Identify and record protocol deviations
• Assist to Central Monitoring Manager with administrative activities, including managing study data, documents and reports
• Ensure site monitors receive information on site related risk & issues. Escalate findings to study teams
• Assists with root cause investigation and follow up on site performance signals identified during central monitoring review

• 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

Lead Clinical Research Associate

• 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.

Manager

• Responsible for operations, communication, and development of strategic site partnerships
• Develops global enrollment and retention solutions to increase patient screening, randomization, and compliance
• Builds and manages patient engagement service offerings and associated costs for global bids, including vendor and in-house resource allocation
• Designs and implements patient engagement assessments for awarded studies, focused on impact measurement, analysis, and mitigation planning
• Participates in scientific conferences, meetings, symposia, etc. to collect information on patient access and diversity
• Assesses patient enrollment challenges and opportunities in ongoing and completed studies to improve patient recruitment and retention strategies
• Liaises with other PSI departments to collate operational feedback and support patient engagement strategy
• Liaises with Project Management to evaluate the impact of recruitment services on patient enrollment metrics for awarded studies
• Collaborates with Business Development and Feasibility to identify and illustrate the value-add of prioritized recruitment services
• Develops and facilitates training programs to department staff and across key functional areas based on area of expertise

Site Relations Manager

Full-stack Engineer

• Full-stack development of in-house Data Management department applications (including desktop and simple web applications)
• Perform all development-related activities, including architecting, developing, testing and maintenance
• Prepare documentation related to development and maintenance of applications
• Use the internal development standards
• Follow the progress of development technologies and advances professional skills as deemed necessary
• Track the development, maintenance and related tasks in the internal tracking system
• Prepare software development plans, including scoping, scheduling, testing and implementation

Full-Stack Programmer

• Full-stack development of in-house Data Management department applications (including desktop and simple web applications)
• Perform all development-related activities, including architecting, developing, testing and maintenance
• Prepare of documentation related to development and maintenance of applications
• Use the internal development standards
• Follow the progress of development technologies and advances professional skills as deemed necessary
• Track the development, maintenance and related tasks in the internal tracking system
• Prepare software development plans, including scoping, scheduling, testing and implementation

Full Stack Programmer

Recruitment

• Operations Develops global enrollment and retention solutions to increase patient screening, randomization, and compliance
• Builds and manages patient engagement service offerings and associated costs for global bids, including vendor and in-house resource allocation
• Designs and implements patient engagement assessments for awarded studies, focused on impact measurement, analysis, and mitigation planning
• Participates in scientific conferences, meetings, symposia, etc. to collect information on patient access and diversity
• Assesses patient enrollment challenges and opportunities in ongoing and completed studies to improve patient recruitment and retention strategies
• Communication Liaises with other PSI departments to collate operational feedback and support patient engagement strategy
• Liaises with Project Management to evaluate the impact of recruitment services on patient enrollment metrics for awarded studies
• Collaborates with Business Development and Feasibility to identify and illustrate the value-add of prioritized recruitment services
• Focus on recruitment project delivery, productivity, and quality to ensure strong customer and patient satisfaction for outreach and retention campaigns.
• Communication with sponsors and project teams to implement and monitor impact of PRR programs and tactical plans based on study performance

Manager, Patient Recruitment and Retention Strategy

• 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

Clinical Research Associate II

Graphics Designer

• The Lead Digital Designer is responsible for the production of designs & layouts for standalone use or in support of larger print, video and interactive web works and reports directly to the Web Manager.
• Responsibilities Communicate with internal & external clients to gather requirements and guide clients through the design process.
• Organise and translate design and layout scope and requirements into final deliverable items for project plans.
• Create and revise designs and layouts following iterative design processes and project plans.
• Plan processes and recommend creative approaches to designing materials for internal & external use.
• Develop and maintain a library of designs and layouts.
• Manage and organise design projects.
• Oversee art and tool budgets.
• Primarily responsible for the PSI Style Guide.
• Stay abreast with emerging design & layout trends and best practices.