Project Manager
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Location: Toronto / hybrid 4 days a week
"• Assisted in project planning activities, including developing timelines, allocating resources, tracking budgets, and ensuring deliverables were completed on time and within financial targets.
• Coordinated with Project Managers, Investigators, and Sponsors.
• Maintained Trial Master File and ensured regulatory compliance.
• Submitted expedited reports to regulatory authorities and sponsors.
• Assisted in developing project timelines and resource allocation plans for PV activities (case processing, SAE reconciliation, regulatory submissions).
• Experience in data processing, reconciliation, quality control, and regulatory/compliance reporting across multiple projects and stakeholders.
• Maintained dashboards, status reports for senior management.
• Prepared status reports, SOPs, and supported audits
• Coordinated with cross-functional teams (Data Management, QA & Regulatory) to ensure deliverables are on schedule.
• Tracked risks, escalated critical issues, and assisted in implementing CAPA and risk management plans to ensure patient safety compliance.
• Maintained governance by following established processes, documenting activities, monitoring compliance, and ensuring accountability for project outcomes.
• Assisted in preparation for internal audits and inspections."
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