Project Manager II, Early Phase
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Skills
About the role
This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Project Manager II, Early Phase based in Canada.
Are you an experienced clinical research professional ready to lead complex early-phase clinical trials from initiation through closeout? This role offers the opportunity to oversee Phase I and II studies, ensuring projects meet their objectives, timelines, budgets, and quality standards. You will serve as a key point of contact for sponsors, vendors, clinical sites, and cross-functional teams, driving effective collaboration throughout the trial lifecycle. Working in a dynamic clinical research environment, you will manage resources, mitigate risks, and uphold regulatory compliance and patient safety. You will also contribute to process improvement, team development, and operational excellence. This is an opportunity to make a meaningful impact on clinical trial delivery while collaborating with talented professionals in a growing, innovation-driven organization.
Accountabilities
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Clinical Trial Management: Lead the initiation, planning, execution, monitoring, and closeout of assigned Phase I and II clinical trials, ensuring delivery within agreed timelines, budgets, scope, and quality standards.
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Stakeholder and Client Relations: Serve as the primary contact for sponsors, vendors, clinical sites, internal study teams, and senior management, maintaining clear communication and providing regular project updates.
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Study Start-Up and Planning: Coordinate study kick-off meetings, site selection and activation, vendor onboarding, site contracting, budget negotiations, Trial Master File (TMF) setup, and essential document collection.
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Budget and Resource Management: Monitor study budgets, resource allocation, project hours, billed time, and out-of-scope activities. Support change order management and implement corrective actions when financial or operational targets are at risk.
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Risk Management and Quality Assurance: Identify and mitigate project risks, implement quality control measures, oversee deliverable quality, and escalate significant issues to the appropriate stakeholders. Review and approve responses to quality audits while ensuring compliance with internal procedures and regulatory requirements.
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Regulatory Compliance and Documentation: Ensure clinical trial activities comply with Good Clinical Practice (GCP), applicable regulations, study protocols, and standard operating procedures. Maintain complete, accurate, and inspection-ready TMF documentation throughout the study lifecycle.
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Cross-Functional Coordination: Work closely with Clinical Operations, Data Management, Regulatory Affairs, Quality Assurance, and other departments to ensure timely completion of protocols, informed consent forms, electronic case report forms, clinical study reports, and other essential deliverables.
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Site and Monitoring Oversight: Track recruitment progress, develop enrollment mitigation plans, support clinical sites, and oversee monitoring activities when required, including site qualification, initiation, routine monitoring, and closeout visits.
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Training and Team Development: Ensure study-specific training plans and records remain current, provide project-related training to Clinical Research Associates (CRAs), and contribute to onboarding, mentoring, and professional development initiatives.
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Continuous Improvement and Business Development: Evaluate project performance, recommend operational improvements, support the development of clinical monitoring plans and tools, and participate in client meetings, proposal presentations, and other business development activities as needed.
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Education: A bachelor's degree in a field related to clinical research is required. A master's degree or PhD is considered an asset.