Project Manager

• Ensure successful initiation, planning, execution, monitoring, controlling and closure of assigned clinical research projects
• Ensure compliance with study budget, project scope, timelines, SOPs, good clinical practices, regulatory and study-specific requirements
• Serve as primary contact for sponsors, vendors and internal teams throughout the study
• Coordinate tasks and deadlines between departments involved in the project
• 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
• Ensure team members are adequately trained on the project
• Plan project activities and resources
• Manage quality of assigned work and deliverables
• Provide project status updates to stakeholders
• Reconcile study trackers and analyze planned versus actual results
• Participate in corrective actions, change control and risk management
• Review and assist with drafting project operational plans, processes and manuals
• Ensure study documents and deliverables meet applicable country requirements
• Oversee site selection and qualification activities
• Monitor patient recruitment and subject status
• Participate in Investigator’s Meetings
• Oversee central ethics and regulatory submissions with Regulatory Affairs
• Ensure collection and maintenance of essential site documents
• Assist with Trial Master File quality reviews and audits
• Support clinical monitoring activities and escalated site issues
• Track site visits, training, monitoring reports, follow-up letters and compliance
• Maintain project-specific training matrix
• Ensure sites have required study materials and supplies
• Support CRF compliance, query resolution and data review through database lock
• 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 experience coordinating activities related 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
• Must be legally able to work in the EU

• Permanent full-time position
• Flexible schedule
• Vacation
• Home-based position
• Ongoing learning and development
• Attractive advancement opportunities
• Equitable treatment and equal opportunity
• Accommodations throughout the recruitment and selection process for applicants with disabilities, upon request