Clinical Trial Manager – I

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

📋 Description

• Provide oversight for site management, clinical monitoring, and central monitoring deliverables, prioritizing patient safety, compliance with protocols/GCP/regulations, and data integrity.

• Manage site interactions from post-activation to site closeout, including patient recruitment and investigator compensation.

• Identify critical risks related to data, processes, and protocol execution, and develop strategies for risk mitigation.

• Review the study scope of work, budget, and protocol content; ensure that clinical project teams are aware of contractual obligations and limits.

• Recognize and escalate risks that may impact timelines, quality, budget, and contractual scope.

• Participate in key meetings, including Kick Off Meetings, and present relevant updates.

• Act as a point of escalation for communications with investigator sites, interacting with principal investigators and site personnel.

• Collaborate with Study Start Up, Patient Recruitment, and Data Management teams to ensure study milestones are achieved.

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

• Ensure that systems such as CTMS, dashboards, and others are configured and functional, overseeing User Acceptance Testing (UAT) and access/audit trail reviews.

• Coordinate initial and ongoing training for the study team.

• Oversee the allocation and conduct of CRAs and Central Monitors, as well as site assignments.

• Ensure the quality and visibility of deliverables related to clinical monitoring, central monitoring, and site management.

• Review oversight dashboards and clinical trial systems, including CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS, and central monitoring dashboards.

• Ensure compliance with monitoring strategies, CMP/SMP, and risk management plans.

• Review documentation from site and central monitoring, ensuring timely delivery according to company or sponsor specifications.

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

• Support readiness for inspections within the clinical trial management scope.

• Supervise CRAs and Central Monitors, evaluate compliance, and identify emerging risks.

• Develop and implement corrective action plans and activities to meet data cut and lock deadlines.

• Offer performance feedback to line managers.

⛳️ Requirements

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

• Proven ability to lead and align teams to achieve project milestones.

• Demonstrated experience working in an international environment.

• Expertise in site management and monitoring, whether clinical or central.

• Preferred experience with risk-based monitoring methodologies.

• Understanding of financial principles related to clinical trial management and budget oversight.

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

• Proficient computer skills.

• Strong communication, presentation, and interpersonal abilities.

• Exceptional conflict resolution skills.

• Capacity to apply problem-solving techniques to address complex issues and utilize a risk management approach.

• Critical thinking skills to identify causes and appropriate solutions.

• Moderate travel may be necessary, approximately 20%.

• Equivalent experience, skills, and/or education will also be taken into account.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management.

• Technical and therapeutic area training provided.

• Recognition from peers.

• Comprehensive total rewards program.

• An inclusive workplace culture.

• Reasonable accommodations for employees or applicants with disabilities, when appropriate.