Description:
Stiris Research is seeking a Project Manager, Clinical Operations, with at least 5 years of clinical trial Project Management experience in oncology to lead the operational planning and delivery of clinical trials across the study lifecycle.
In this role, you will manage study timelines, quality expectations, budget oversight, and cross-functional coordination across internal teams, sites, sponsors, and service providers ensuring studies are delivered in alignment with protocol requirements, ICH-GCP, sponsor expectations and operational best practices.
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.