Project Manager II, Early Phase
New
J
JobgetherClinical research
Work remotely from anywhere in Canada or from the organization's Montreal headquartersFull-TimeMiddle
Salary not disclosed
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Job Details
- Languages
- Excellent written and verbal communication skills in English. Bilingual proficiency in English and French is highly desirable.
- 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.
- Required Skills
- Microsoft Office
Requirements
- Bachelor's degree in a field related to clinical research.
- At least five years of experience in the clinical research industry.
- At least three years managing Phase I and Phase II clinical trials.
- Experience managing multiple clinical trials simultaneously across several sites.
- Capability in trial planning, budgeting, resource allocation, risk management, and stakeholder coordination.
- Strong understanding of GCP, ICH guidelines, applicable Health Canada and FDA regulations, and other relevant local regulatory requirements.
- Proficiency in Microsoft Office applications.
- Familiarity with clinical research documentation, trial management processes, monitoring activities, and TMF requirements.
- Solid scientific understanding of clinical research and knowledge of site management, data review, regulatory submissions, and quality assurance.
- Previous dermatology clinical trial experience is strongly preferred.
- A master's degree or PhD is considered an asset.
- Excellent written and verbal communication skills in English; English-French bilingual proficiency is highly desirable.
Responsibilities
- Lead assigned Phase I and II clinical trials from initiation and planning through execution, monitoring, and closeout.
- Serve as the primary contact for sponsors, vendors, clinical sites, internal study teams, and senior management.
- Coordinate study kick-off meetings, site selection and activation, vendor onboarding, contracting, budget negotiations, TMF setup, and essential document collection.
- Monitor study budgets, resource allocation, project hours, billed time, and out-of-scope activities; support change orders and corrective actions.
- Identify and mitigate project risks, implement quality controls, review audit responses, and escalate significant issues.
- Ensure trial activities comply with GCP, applicable regulations, protocols, and standard operating procedures, and maintain inspection-ready TMF documentation.
- Coordinate with cross-functional teams to complete protocols, informed consent forms, electronic case report forms, clinical study reports, and other deliverables.
- Track recruitment, develop enrollment mitigation plans, support sites, and oversee monitoring activities and visits when required.
- Maintain study-specific training plans and records, train CRAs, and contribute to onboarding, mentoring, and professional development.
- Evaluate project performance, recommend operational improvements, and support monitoring plans, client meetings, proposals, and business development activities.
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