Canada

Project Manager, Clinical Operations - Stiris Research Inc. …, Langley

Project Manager, Clinical Operations - Stiris Research Inc. …, Langley
Description
Here we grow again! 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 explicit 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. - 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 in Oncology and/or Rare Diseases - 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. Apply on Kit Job: kitjob.ca/job/2oyxnh
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