PSI CRO AG is a global, full-service Contract Research Organization renowned for its reliable patient enrollment and on-time project delivery across diverse therapeutic areas.
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PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas. PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines. PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world. PSI’s reputation is that of a 'no-nonsense' CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees. http://www.psi-cro.com
Hybrid · Mississauga
The role involves managing the exchange of documentation and clinical supplies between sites and vendors while ensuring regulatory compliance. It also includes maintaining tracking systems, coordinating audits, and providing training to site teams.
Hybrid · Mississauga
The Site Management Associate ensures the proper exchange of information, documentation, and clinical supplies between sites and vendors. They also manage regulatory submissions, maintain study-specific tracking systems, and provide training to site teams on project-specific systems.
Hybrid · Mississauga
The role focuses on coordinating communication and documentation between clinical sites and vendors, ensuring regulatory compliance and supply management. It also involves managing the Trial Master File (TMF), updating CTMS, and supporting site training and audits.
Remote · Canada
The role involves streamlining project team activities and ensuring consistency of clinical operations processes across the Asia Pacific region. Key duties include managing study milestones, reporting progress to stakeholders, and overseeing site selection and monitoring activities.
On-site · Toronto
The Clinical Regional Project Lead will streamline project team activities and ensure consistency in Clinical Operations processes across the Asia Pacific region. Responsibilities include managing project timelines, overseeing site selection and startup, and ensuring team compliance with monitoring and reporting standards.
On-site · Toronto
Lead biostatistics activities for clinical trials, including developing statistical analysis plans and protocols. Perform statistical analysis, validate SAS programs, and consult on experimental designs to assess drug safety and efficacy.
On-site · Toronto
Lead all biostatistics activities for clinical trials, including protocol development, statistical analysis plans, and database structure documentation. Communicate with project teams and clients while ensuring the quality and regulatory compliance of all statistical deliverables.
Remote · Mississauga, Ontario, Canada
Lead the study activation process on a country level, ensuring that clinical research projects start smoothly and on time. Collaborate with project teams for site activation, facilitate agreements, and coordinate necessary documentation.
On-site · Mississauga
Lead the study activation process at a country level to ensure clinical research projects start smoothly and on time. This includes managing site agreements, contract negotiations, and the submission of study dossiers to competent authorities and IRBs.
On-site · Mississauga
Lead the study activation process at a country level to ensure clinical research projects start smoothly and on time. This includes managing site agreements, contract negotiations, and the submission of study dossiers to regulatory authorities.
Remote · Canada
Medical Monitors provide medical input to global clinical studies and ensure patient safety and well-being. They act as the primary contact for medical and safety-related questions and participate in various trial-related activities.
Remote · Canada
Provide medical input and safety oversight for global clinical studies to ensure patient well-being. Act as the primary medical contact for regulatory authorities, IRBs, and trial teams while managing medical risks and reviewing clinical data.
On-site · Mississauga
Prepare and manage clinical trial submission dossiers for Regulatory and Ethics Authorities, specifically for the US and Canadian markets. Coordinate with authorities, project teams, and vendors while managing safety reporting and regulatory training.
Remote · Canada
PSI Medical Monitors provide medical input to global clinical studies and advise teams on patient safety and well-being. They act as the primary contact for trial-specific medical and safety-related questions and participate in various trial-related activities.
Remote · United States
Provide medical input and safety oversight for global clinical studies, acting as the primary contact for medical and safety-related queries. Responsibilities include monitoring participant safety, reviewing clinical study reports, and training trial teams on therapeutic protocols.
Remote · Canada
Provide medical input and safety oversight for global clinical studies, acting as the primary contact for medical and safety-related queries. Responsibilities include monitoring participant safety, reviewing clinical study reports, and training trial teams on therapeutic protocols.
Remote · Canada
Provide medical input and safety oversight for global clinical studies, acting as the primary contact for medical and safety-related queries. Responsibilities include monitoring participant safety, reviewing clinical study reports, and training trial teams on therapeutic protocols.
Remote · United States
Provide medical input and safety oversight for global clinical studies, acting as the primary contact for medical and safety-related queries. Responsibilities include monitoring participant safety, reviewing safety reports, and training trial teams on therapeutic protocols.
On-site · Toronto
The Senior CRA is responsible for conducting onsite monitoring visits, including SIV, RMV, and COV, while managing site communications and CRF reviews. They also support regulatory submissions, participate in feasibility research, and prepare for audits and inspections.
Remote · Mississauga, Ontario, Canada
The Proposal Manager coordinates all phases of the proposal process, from RFP strategy to bid defense slide decks. This includes developing competitive budgets, writing strategic proposals, and collaborating with global subject matter experts to maintain a high win rate.
