Within this sponsor, the Clinical Trial Leader (CTL) serves at the Senior Project Manager level and plays a pivotal leadership role within the Clinical Delivery Team. This position provides strategic global oversight, driving alignment, direction, and accountability across Phase II and III clinical trials conducted worldwide. The CTL ensures precise planning, efficient execution, and high-quality delivery of trials that bring speed and value to patients and investigative sites.

This role is hybrid, requiring approximately 50% onsite presence in Burlington, Ontario. Time in the office is highly collaborative and energizing — you’ll work alongside scientists, operational leaders, and cross-functional partners who depend on your leadership to keep global teams aligned. The onsite culture emphasizes real-time problem solving, strong relationships, and a shared commitment to operational excellence. If you enjoy being a visible leader who influences teams across continents, this environment is a true advantage.

Operating across multi-country, multi-regional trials, the CTL provides strong global project management leadership, ensuring milestones, KPIs, and strategic objectives are met. Therapeutic areas include Immunology, Metabolic, and Oncology. Candidates must have extensive Project Management experience leading Phase II & III trials globally, with proven ability to influence and guide diverse teams.

Global Trial Preparation

• Lead global planning activities and operational feasibility assessments, ensuring timelines and strategies are realistic and globally aligned.

• Strengthen cross-functional cohesion by working onsite with colleagues in Statistics, Data Management, Medical Writing, Site Monitoring, Quality, and Regulatory.

• Guide country allocation and feasibility processes, helping shape global site strategies with operational insight.

• Develop robust global engagement, recruitment, and risk mitigation plans informed by patient, site, and regional feedback.

• Lead vendor outsourcing strategy—identification, evaluation, and scope-of-work development—ensuring global operational readiness.

• Bring teams together onsite to harmonize trial processes across clinical quality, safety, investigational product management, and financial planning.

• Prepare or support responses to regulatory and ethics authorities across regions.

• Ensure global teams are trained, aligned, and equipped for execution.

Global Trial Conduct

• Maintain high-level oversight of worldwide trial operations, ensuring compliance with GCP, SOPs, and diverse regional regulations.

• Monitor global patient recruitment, risks, timelines, and budgets, driving issue resolution through clear leadership.

• Direct documentation changes, study amendments, and retraining across all regions and functions.

• Provide strong oversight of global vendors, central labs, and external partners, ensuring consistent performance.

• Serve as the connective tissue across global clinical delivery, fostering open communication and unity of purpose.

• Coordinate biomarker, genomic, and sub-study activities for applicable early-phase trials, often requiring cross-regional alignment.

Trial Closeout & Reporting

• Provide global leadership through data cleaning, database lock, and closeout activities.

• Support CTR development and ensure timely global registry disclosure.

• Ensure completeness and accuracy of the Trial Master File (TMF) across all participating regions.

• Support scientific publications and global communication of study outcomes.

Strategic Contributions

• Partner with portfolio leaders to provide operational and scientific insight that shapes global study strategy.

• Elevate risks, bottlenecks, and insights to the Evidence Team to drive swift, coordinated solutions.

• Lead or contribute to global feasibility assessments that influence trial design, operational models, and regional planning.

Required

• Bachelor’s degree (4-year undergraduate degree).

• Proven experience providing global leadership across Phase II & III clinical trials.

• Therapeutic area experience in Immunology, Metabolic, or Oncology.

• Deep understanding of global clinical trial planning, execution, and regulatory landscapes.

• Exceptional leadership, communication, and stakeholder management skills across complex, matrixed, multicultural environments.

• Ability to lead through influence, anticipate global challenges, and ensure patient-focused outcomes.

Core Competencies

• Global Leadership: Confidently guide teams across regions, cultures, and functions; set vision, instill accountability, and shape high-performing global execution.

• Strategic Mindset: Think several steps ahead, anticipate challenges, and align global strategies with portfolio needs.

• Project Management Excellence: Expert in global timelines, risk mitigation, cross-functional coordination, issue escalation, and solution delivery.

• Collaboration & Influence: Build trust across continents; unify teams through clear direction and inspiring presence onsite.

• High-Impact Communication: Transparent, diplomatic, and culturally attuned communicator who elevates team performance.

This is not a traditional project management role — it is a chance to be at the center of global clinical delivery. As a Senior Global Project Manager / Clinical Trial Leader, you will be a visible, influential leader driving the success of trials that span continents. The hybrid model gives you the best of both worlds: meaningful onsite collaboration that strengthens team cohesion, paired with the flexibility of remote work.

You will shape strategy, drive execution, and help deliver therapies that change lives. Your leadership will connect people, processes, and science — ensuring trials advance efficiently, ethically, and with global impact.