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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.
Required Qualifications
- 5+ years of experience as a Clinical Project Manager role , leading end-to-end trial execution.
- 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
How to Apply:
Please submit your CV to Allyson MacLean () with the subject line: Project Manager, Clinical Operations.
