Clinical Trial Manager I

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

📋 Description

• Manage site operations, clinical monitoring, and central monitoring deliverables, prioritizing patient safety, adherence to protocols/GCP/regulatory standards, and data integrity.

• Oversee site engagement from activation to closeout, including patient recruitment and investigator payments as needed.

• Identify risks associated with clinical trial management and create or execute risk mitigation strategies.

• Analyze the study's scope of work, budget, and protocol content; ensure the clinical project team comprehends contractual responsibilities and parameters.

• Raise concerns regarding risks to timelines, quality, budget, and activities that fall outside the agreed scope to the project manager.

• Engage in and present at essential meetings, including Kick-Off Meetings.

• Act as a point of escalation for communications with investigator site staff and collaborate with principal investigators and site personnel.

• Work together with Study Start Up, Patient Recruitment, Data Management, and other functional leaders to achieve study milestones.

• Create and maintain tools and templates for clinical studies, including the Clinical Monitoring Plan.

• Ensure CTMS, dashboards, and other systems are properly configured and accessible, including managing UAT when necessary.

• Organize initial and ongoing training for the study team.

• Supervise CRA and Central Monitor resources, site assignments, and assess delivery risks.

• Evaluate the quality and visibility of clinical monitoring, central monitoring, and site management deliverables using established systems and tracking tools.

• Review CTMS, EDC, eDiary, ePRO, TMF, IVRS/IWRS, and central-monitoring dashboards to manage site and patient activities.

• Ensure adherence to the monitoring strategy, CMP/SMP, and risk management plans.

• Examine site and central monitoring documentation for quality, completeness, and potential risks to compliance, patient safety, and data integrity.

• Collaborate with clients and functional departments regarding clinical monitoring and site management deliverables.

• Provide updates on clinical deliverables and associated risks to clients, project management, and leadership.

• Support readiness for inspections, corrective action plans, data cuts, and database lock activities.

• Supervise assigned CRAs and Central Monitors, evaluating processes, training, and compliance with the CMP.

• Offer performance feedback to line managers.

⛳️ Requirements

• Bachelor’s degree or RN in a relevant field, or an equivalent combination of education, training, and experience.

• Capability to lead and align teams to meet project milestones.

• Ability to work effectively in an international setting.

• Prior experience in clinical trial site management.

• Preferred background in risk-based monitoring and clinical or central monitoring.

• Understanding of financial principles and budget management practices.

• Knowledge of Good Clinical Practice/ICH Guidelines and relevant regulatory requirements.

• Proficient computer skills.

• Strong communication, presentation, and interpersonal skills.

• Basic skills in conflict resolution.

• Problem-solving and risk management capabilities for complex clinical research challenges.

• Analytical thinking skills to identify root causes and appropriate solutions.

• Willingness to travel moderately, approximately 20%.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and involved line management.

• Training in technical and therapeutic areas.

• Recognition among peers and a comprehensive rewards program.

• An inclusive organizational culture.

• Access to extensive resources, including emerging technologies, data, science, and knowledge sharing.

• Collaboration with specialized teams aligned therapeutically or functionally.

• A range of diverse career paths and employment opportunities.

• Reasonable accommodations provided when appropriate.