Project Manager, Clinical Operations (Phase I–IIIB)

About Stiris Research

Stiris Research is an entrepreneurial Clinical Trial Management Company providing Phase I through IIIB full-service support to Biotechnology and Biopharmaceutical companies. We make a difference by collaborating in the life sciences to improve others' lives.

Project Manager, Clinical Operations (Phase I–IIIB)

Work model: Remote (Canada preferred, U.S. considered)

Employment type: Full-time

Position Summary

Stiris Research is seeking an experienced Project Manager, Clinical Operations, with 5+ years of Project Manager experience to lead the operational planning and delivery of clinical trials across the study lifecycle. You will manage study timelines, quality expectations, budget oversight, and cross-functional coordination across internal teams, sites, sponsors, and service providers.

Key Responsibilities

• Own the quality and timeliness of study deliverables across feasibility, start-up, site activation, recruitment, conduct, database cleaning, and close-out.
• Lead and coordinate cross-functional teams to deliver study milestones with clear expectations, communication, and accountability.
• Build and maintain strong relationships with sponsors, sites, service providers, and internal stakeholders.
• Track and proactively manage study timelines, KPIs, metrics, and projections, maintain risk and issue logs, and escalate risks with clear mitigation plans.
• Establish and run appropriate study governance (e.g., sponsor updates, internal project reviews), including clear documentation of decisions and action items.
• Manage resourcing needs and support team performance, onboarding, and study-specific training throughout trial delivery.
• Maintain oversight of study budget health, including forecasting, and proactively escalate risks or variances to support timely, informed decisions.
• Oversee service provider performance and deliverables, ensuring expectations, quality standards, and timelines are met, address issues promptly and document outcomes.
• Assess operational performance and develop corrective and preventive action plans for site, service providers, and administrative issues.
• Support sponsor-specific processes, including SOP mapping and alignment activities.
• Support quality oversight and inspection readiness, including oversight of trial essential records (TMF/ISF) completeness and compliance with ICH-GCP and applicable requirements.
• Contribute to continuous improvement through lessons learned, process enhancements, and knowledge sharing with project team members.

Key Deliverables

• Study execution: Successful delivery of assigned clinical trials in accordance with approved protocols, timelines, budgets, quality standards, and applicable regulations.
• Study plans and timelines: Development and ongoing maintenance of integrated study plans, timelines, milestones, and critical path activities.
• Study governance: Timely and effective sponsor and internal governance meetings, status reporting, decision tracking, and follow-up of action items.
• Risk and issue management: Proactive identification, documentation, escalation, and mitigation of study risks and issues, with clear ownership and follow-through.
• Study metrics and reporting: Accurate and timely reporting of study KPIs, recruitment progress, site performance, milestones, projections, and other key operational metrics.
• Budget oversight: Ongoing monitoring, forecasting, and reporting of study financial performance, including timely identification and escalation of variances.
• Vendor and service provider oversight: Effective oversight of CROs, vendors, and other service providers to ensure contracted deliverables meet quality, timeline, and performance expectations.
• Site performance: Proactive management of site activation, recruitment, performance, and issue resolution to support study objectives.
• Quality and inspection readiness: Maintenance of appropriate oversight of essential study documentation, TMF/ISF completeness, and compliance with ICH-GCP and applicable regulatory requirements.
• Study close-out: Timely completion of study close-out activities, outstanding action items, documentation, financial reconciliation, and lessons learned.
• Continuous improvement: Identification and implementation of practical process improvements and lessons learned that strengthen future study delivery.

Required Qualifications

• 5+ years of experience as a Clinical Project Manager role, leading end-to-end trial execution.
• Experience managing studies at a CRO preferred.
• Experience in Oncology.
• Strong working knowledge of ICH-GCP and applicable regulatory/quality requirements.
• Demonstrated experience managing sites, timelines, study metrics, service providers, and budgets.
• Strong leadership and stakeholder management skills; able to influence, align, and drive accountability across diverse teams.
• Excellent organizational, analytical, and communication skills; comfortable operating under pressure and shifting priorities.
• Strong computer literacy, including MS Word, Excel, Outlook, SharePoint, and clinical systems such as CTMS and TMF.

Preferred Qualifications (Optional)

• Experience working with both Canadian and U.S. sites/sponsors.
• PMP certification and/or relevant life sciences degree.

Compensation

Salary range: CAD $100,000 – $130,000