This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Clinical Trial Manager I based in Canada.
This is an opportunity to contribute to the successful delivery of clinical trials in a fully remote environment.
You will oversee site management, clinical monitoring, and operational deliverables with a strong focus on patient safety, compliance, and data integrity.
The role combines clinical expertise, risk management, stakeholder coordination, and team leadership.
You will work closely with CRAs, Central Monitors, project managers, clients, investigators, and cross-functional teams.
Your work will help keep studies on track across milestones such as site activation, patient enrollment, data cut, and database lock.
The environment is international, collaborative, fast-paced, and focused on improving the development of therapies for patients worldwide.
Moderate travel may be required, with the position offering a remote-first setup within Canada.
Accountabilities:
- Oversee clinical monitoring, site management, and central monitoring activities from site activation through closeout, ensuring patient safety, protocol adherence, GCP/regulatory compliance, and data integrity.
- Monitor study progress, operational data, dashboards, and clinical trial systems to identify risks affecting timelines, quality, budget, site performance, or study deliverables.
- Develop and implement appropriate risk mitigation strategies, including supporting risk assessments, corrective action plans, and risk-based monitoring activities.
- Review study scope, protocols, budgets, monitoring strategies, and contractual requirements, ensuring clinical teams understand their responsibilities and delivery expectations.
- Serve as an escalation point for investigator sites and study teams, addressing operational challenges, communication issues, and protocol execution obstacles.
- Coordinate closely with Study Start-Up, Patient Recruitment, Data Management, Medical Monitoring, Pharmacovigilance, Quality Assurance, and other functions to ensure smooth handoffs and achievement of study milestones.
- Develop and maintain clinical study tools, templates, monitoring plans, dashboards, and tracking systems, including supporting user acceptance testing and system access or audit-trail reviews.
- Coordinate protocol-specific and study-related training for CRAs, Central Monitors, and other clinical team members.
- Oversee resource allocation, site assignments, team conduct, monitoring quality, and compliance with study-specific plans and procedures.
- Review the quality and completeness of monitoring reports, site documentation, correspondence, and central monitoring deliverables, ensuring risks and required actions are appropriately documented.
- Provide regular status updates to clients, project management, and leadership regarding clinical deliverables, risks, milestones, and potential solutions.
- Support inspection readiness and ensure clinical trial activities align with applicable SOPs, ICH GCP, protocols, and country-specific regulations.
- Provide feedback to line managers on team-member performance, strengths, development opportunities, and emerging delivery risks.
- Participate in key study meetings, including project kick-offs, and contribute clinical expertise to strategic discussions and decision-making.
Requirements:
- Bachelor’s degree, RN qualification, or equivalent combination of education, training, and relevant experience in a related field.
- Previous experience in clinical trials and site management, with experience overseeing clinical teams and study deliverables.
- Experience with risk-based monitoring, clinical monitoring, or central monitoring is preferred.
- Knowledge of Good Clinical Practice (GCP), ICH guidelines, and applicable regulatory requirements.
- Ability to lead and align multidisciplinary teams toward study milestones and operational objectives.
- Strong understanding of clinical trial operations, including site activation, monitoring, enrollment, data management, and database lock activities.
- Familiarity with financial principles and clinical project budget-management practices.
- Strong analytical, critical-thinking, and problem-solving abilities, with the capacity to identify root causes and develop effective risk mitigation strategies.
- Good computer skills and the ability to work effectively with clinical trial systems, dashboards, and tracking tools.
- Strong written, verbal, presentation, and interpersonal communication skills, particularly when interacting with investigators, clients, project teams, and cross-functional stakeholders.
- Basic conflict-resolution skills and the ability to manage challenging site or project situations constructively.
- Ability to work effectively in an international, collaborative, and fast-changing environment.
- Strong organizational skills and the ability to manage multiple priorities while maintaining quality and meeting study timelines.
- Moderate travel may be required, approximately 20%.
Benefits:
- Fully remote position within Canada.
- Full-time employment.
- Opportunity to contribute to clinical research and the development of therapies that can improve patients’ lives worldwide.
- Career development and progression opportunities.
- Supportive and engaged line management.
- Technical and therapeutic-area training.
- Peer recognition and total rewards programs.
- Access to specialized teams and multidisciplinary collaboration.
- Exposure to international clinical research programs, emerging technologies, data, science, and knowledge-sharing initiatives.
- Opportunities to develop expertise across different therapeutic and functional areas.
- Inclusive and collaborative work environment where diverse perspectives are valued.
- Moderate travel of approximately 20%, depending on study requirements.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
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