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Canada
Remote only
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Education: A bachelor's degree in a field related to clinical research is required. A master's degree or PhD is considered an asset.
Clinical Research Experience: At least five years of experience in the clinical research industry, including a minimum of three years managing Phase I and Phase II clinical trials.
Project Management Expertise: Demonstrated experience managing multiple clinical trials simultaneously across several sites, with strong capabilities in planning, budgeting, resource allocation, risk management, and stakeholder coordination.
Therapeutic Experience: Previous experience in dermatology clinical trials is strongly preferred.
Regulatory Knowledge: Strong understanding of Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, applicable Health Canada and FDA regulations, and other relevant local regulatory requirements.
Technical Proficiency: Proficiency in Microsoft Office applications and familiarity with clinical research documentation, trial management processes, monitoring activities, and TMF requirements.
Communication Skills: Excellent written and verbal communication skills in English. Bilingual proficiency in English and French is highly desirable.
Scientific and Operational Knowledge: Solid scientific understanding of clinical research and broad knowledge of cross-functional clinical trial operations, including site management, data review, regulatory submissions, and quality assurance.
Leadership and Collaboration: Ability to build productive relationships with sponsors, colleagues, vendors, and clinical sites while fostering collaboration across multidisciplinary teams.
Organization and Problem-Solving: Strong critical-thinking, analytical, and creative problem-solving skills, with the ability to manage competing priorities, work effectively under pressure, and consistently meet deadlines.
Adaptability and Initiative: A proactive, detail-oriented approach, with the flexibility to respond to changing project needs and contribute to process improvements and operational excellence.
Employment Type: Permanent, full-time position.
Work Flexibility: Flexible working hours and the option to work remotely from anywhere in Canada or from the organization's Montreal headquarters, subject to company policies.
Comprehensive Benefits: Medical, dental, and vision coverage.
Retirement Savings: Registered Retirement Savings Plan (RRSP).
Time Off: Vacation allowance and personal days.
Additional Perks: Access to a virtual medical clinic, public transportation rebates, and social activities.
Professional Development: Ongoing learning opportunities and support for career advancement.
Work Environment: A collaborative, innovative, and supportive team culture focused on research quality, responsiveness, and continuous improvement.
Office Access: Occasional visits to the Montreal office may be required or encouraged.
Accessibility and Inclusion: Accommodations are available upon request throughout the recruitment and selection process.
Eligibility: Applicants must be legally authorized to work in Canada.
