Project Manager

• Ensure successful initiation, planning, execution, monitoring, controlling and closure of assigned clinical research projects
• Ensure compliance with study budgets, project scope, timelines, SOPs, good clinical practices, regulatory and study-specific requirements
• Serve as a primary contact for sponsors, vendors and internal teams throughout the study
• Coordinate tasks and deadlines between departments
• Oversee project coordinators, SSU team members, RDA and RAC resources and prioritize site activation activities
• Coordinate vendor supplies and services with site activation timelines
• Escalate risks to site activation timelines to Project Manager II
• Manage sponsor and stakeholder needs and expectations
• Support team training and plan project activities and resources
• Manage work quality and deliverables and provide project status updates
• Reconcile study trackers and analyze discrepancies between planned and actual results
• Support corrective actions, change control and risk management
• Review and assist with project operational plans, processes and manuals
• Ensure study documents and deliverables meet applicable country requirements
• Oversee site selection and feasibility activities
• Monitor patient recruitment and subject status and follow up with sites
• Participate in Investigator’s Meetings
• Oversee central ethics and regulatory submissions with Regulatory Affairs
• Ensure collection and maintenance of essential site documents
• Assist with TMF quality reviews and audits for inspection readiness
• Support clinical monitoring activities, including CRA training, visit report review, site letters and escalated site issues
• Track site visits, training, monitoring reports, follow-up letters and site-related issues
• Maintain the project-specific training matrix
• Ensure sites have necessary study materials and supplies
• Support CRF compliance, query resolution and data review through database lock with Data Management
• Provide technical, therapeutic and project management expertise in training and process improvement

• B.Sc. in a related field of study to clinical research
• At least 3 years of experience in a similar role, including activities related to management of clinical studies in the pharmaceutical, biotechnology and/or CRO industry
• At least 2 years of experience coordinating activities related to clinical trial management
• Excellent knowledge of GCP and ICH standards, FDA and Canadian regulations
• Excellent knowledge of Microsoft Office suite
• Excellent oral and written skills in English
• French is an asset
• Excellent communication skills
• Ability to work in a team environment and establish good relationships with colleagues and sponsors
• Good problem-solving abilities
• Good organizational skills
• Strong ability to carry out different projects and work under pressure while meeting timelines
• Experience managing small to medium projects using a disciplined approach to project management
• Demonstrated ability to establish and deliver resource-based project plans
• Excellent people management skills; experience working with and managing teams in a matrix environment
• Legally able to work in the EU

• Permanent full-time position
• Flexible schedule
• Vacation
• Home-based position
• Ongoing learning and development
• Attractive advancement opportunities
• Equal opportunity and disability accommodations throughout recruitment and selection upon request