Senior Project Manager, Early Phase and Translational Research

This is a fully remote position, open to applicants in Canada.

📋 Description

• Supervise and oversee clinical research projects on a domestic, regional, and/or international scale.

• Develop and lead project teams while managing communications, risks, scope, schedules, costs, quality, and stakeholders.

• Act as the main point of contact for sponsors, sites, CRAs, vendors, and internal teams.

• Direct the clinical trial process from initiation to planning, execution, monitoring, control, and closure.

• Contribute to feasibility assessments, study design, budget formulation, and progress reporting.

• Ensure that assigned studies are consistently audit-ready.

• Serve as the escalation point for project-related issues and proactively address conflicts.

• Oversee trial timelines, budgets, resources, vendors, and cross-functional tasks and deliverables.

• Manage project budgets, review billed hours, and identify activities that are out-of-scope for change orders.

• Provide updates on trial progress and manage KPIs, resources, and succession plans.

• Lead study start-up activities, including kick-off meetings, TMF setup, site selection and activation, vendor setup, contracting, and budgeting.

• Manage risks and quality control measures; escalate issues to management, quality assurance, and sponsors as necessary.

• Facilitate client, internal work group, and vendor meetings; distribute and archive meeting minutes.

• Monitor study deliverables and implement corrective actions and quality enhancements.

• Maintain training matrices specific to projects and review training documentation.

• Review and approve responses to quality assurance audits.

• Ensure that study documents and project deliverables are submitted in a timely and compliant manner.

• Oversee TMF filing, maintenance, and archiving processes.

• Manage and report on recruitment status and mitigation strategies.

• Participate in Investigator Meetings.

• Collaborate with Regulatory Affairs on submissions and essential documentation.

• Supervise clinical monitoring activities and contribute to the Clinical Monitoring Plan.

• Train CRAs and potentially conduct study initiation visits.

• Create site visit reports and monitoring tools.

• Provide support to sites with investigational products, supplies, equipment, and safety lab kits.

• Collaborate with Data Management on CRF compliance, query resolution, data review, and database lock procedures.

• Mentor team members and contribute to training, process improvement initiatives, and business development presentations.

⛳️ Requirements

• Bachelor’s degree in a field related to clinical research.

• Minimum of 7 years of industry experience.

• At least 5 years in Phase I-III clinical trial project management with financial accountability.

• Proven experience leading concurrent multi-centered, multinational clinical trials with budgets exceeding $25M USD.

• PMP certification is preferred.

• Experience in cost management, study start-up, regulatory submissions, resource management, supervisory roles, CRA, data management, medical writing, or vendor management is considered advantageous.

• Therapeutic experience in managing dermatology trials is a plus.

• Strong understanding of GCP and ICH standards, as well as FDA and local regulations.

• Proficient in Microsoft Office Suite.

• Fluency in English with excellent oral and written communication skills is essential.

• Bilingualism (English and the local language) is an asset.

• Ability to thrive in a team environment and build strong relationships with colleagues and sponsors.

• Strong problem-solving skills.

• Exceptional ability to multitask and manage various projects under pressure while meeting deadlines.

• Good knowledge of relevant Health Canada and FDA regulations/guidelines.

• Must have legal authorization to work in Canada.

🏝️ Benefits

• Engaging work environment.

• Competitive advancement opportunities.

• Remote position based in Canada.

• Equal opportunity and disability accommodations available throughout recruitment and selection upon request.