Project Manager II, Early Phase

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Project Manager II, Early Phase based in Canada.

This role offers the opportunity to lead complex early-phase clinical research programs from initiation through completion.
You will act as a key connection point between sponsors, clinical teams, vendors, and internal stakeholders.
The position requires strong project leadership, operational expertise, and the ability to deliver high-quality clinical trials on time and within budget.
You will oversee study execution, risk management, regulatory compliance, and cross-functional collaboration in a dynamic research environment.
The role provides meaningful ownership over clinical programs that contribute to advancing innovative treatments.
You will work alongside experienced professionals while contributing to process improvements and operational excellence.
This is an ideal opportunity for a clinical research project manager seeking impact, autonomy, and long-term growth.

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.

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…