Project Manager II, Early Phase

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.

• 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.