Project Manager II, Early Phase

Accountabilities:
The Project Manager II, Early Phase and Translational Research will oversee the successful delivery of assigned clinical trials by managing timelines, budgets, resources, quality standards, and stakeholder communication. The role requires strong coordination across sponsors, vendors, study teams, and clinical sites while ensuring compliance with regulatory requirements and clinical research best practices. Serve as the primary point of contact for sponsors, vendors, internal teams, and study stakeholders throughout the full clinical trial lifecycle. Lead study planning, initiation, execution, monitoring, and close-out activities while ensuring alignment with timelines, budgets, scope, and quality expectations. Coordinate operational activities including site selection and activation, vendor management, study documentation, training, and clinical operations deliverables. Manage project budgets by monitoring resource allocation, reviewing costs, identifying out-of-scope activities, and supporting change management processes. Provide regular project updates, dashboards, risk assessments, and status reports to internal and external stakeholders. Identify potential risks, implement mitigation strategies, and escalate issues when necessary to maintain study progress. Oversee Trial Master File (TMF) completeness, essential documentation, and inspection readiness in accordance with SOPs and regulatory requirements. Ensure study teams and service providers receive appropriate training and maintain accurate training records. Support clinical monitoring activities, site management, data review processes, and collaboration with regulatory and clinical operations teams. Contribute to the development of monitoring plans, operational tools, process improvements, and departmental initiatives. Mentor junior team members and support knowledge sharing, onboarding, and continuous improvement efforts. Participate in business development activities, including client meetings, proposals, and strategic discussions when required. Requirements: The ideal candidate has strong clinical research expertise combined with proven project management experience in early-phase trials. They are organized, detail-oriented, and comfortable managing multiple priorities while collaborating with diverse stakeholders in a regulated environment. Bachelor’s degree in clinical research, life sciences, or a related field; a Master’s degree or Ph.D. is considered an asset. Minimum of 5 years of experience in the clinical research industry, including at least 3 years managing Phase I and Phase II clinical trials. Experience managing multiple clinical studies simultaneously across different sites and stakeholders. Strong understanding of Good Clinical Practice (GCP), ICH guidelines, FDA requirements, Health Canada regulations, and applicable clinical research standards. Experience with clinical trial operations, study start-up activities, vendor management, budgets, and regulatory documentation. Previous experience with dermatology clinical trials is strongly preferred. Excellent written and verbal communication skills in English; bilingual English/French skills are highly desirable. Strong problem-solving, critical-thinking, organization, and decision-making abilities. Ability to manage competing priorities, meet deadlines, and perform effectively in a fast-paced environment. Proficiency with Microsoft Office Suite and clinical research documentation systems. Ability to build strong relationships with sponsors, colleagues, vendors, and clinical partners. Benefits: Permanent full-time position with the flexibility to work remotely anywhere in Canada. Flexible work schedule supporting work-life balance. Comprehensive benefits package including medical, dental, and vision coverage. Retirement savings program (RRSP), vacation time, and personal days. Access to a virtual medical clinic and additional employee support programs. Opportunities for ongoing learning, professional development, and career advancement. Collaborative environment focused on innovation, reliability, and teamwork. Opportunity to contribute to impactful clinical research programs advancing healthcare solutions. Occasional opportunities to connect with colleagues through office visits and team activities.

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