Senior Clinical Project Manager
New
CanadaFull-TimeSenior
Salary$125,000 – $175,000
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Job Details
- Experience
- More than 10 years of experience in clinical research and development; Minimum of 7 years of clinical project management experience
- Required Skills
- Cross-functional Team LeadershipBudget management
Requirements
- Bachelor’s or Master’s degree in life sciences, health sciences, or a related field.
- More than 10 years of experience in clinical research and development within a pharmaceutical, biotechnology, healthcare, or CRO environment.
- Minimum of 7 years of clinical project management experience with demonstrated expertise in managing clinical trial activities.
- Experience overseeing Phase I–IV clinical studies from initiation through regulatory submission and completion.
- Strong knowledge of ICH guidelines and regulatory requirements, including FDA, Health Canada, EMA, and other applicable standards.
- Experience managing cross-functional clinical activities, including site selection, study start-up, data management, and vendor oversight.
- Demonstrated ability to lead teams, manage resources, and deliver projects within defined timelines and budgets.
- Strong financial management skills, including budget planning, forecasting, cost tracking, and change order management.
- Oncology clinical research experience is highly preferred.
- Previous clinical trial monitoring experience is an asset.
Responsibilities
- Lead the planning, execution, monitoring, and closure of Phase I–IV clinical trials while ensuring compliance with applicable regulations, guidelines, and quality standards.
- Manage cross-functional project teams across clinical operations, statistics, data management, regulatory submissions, medical writing, and vendor management.
- Develop and maintain detailed project plans, timelines, budgets, resource forecasts, and risk mitigation strategies.
- Track project progress, identify issues or deviations, and implement corrective actions to ensure successful delivery.
- Prepare and present project status reports to internal and external stakeholders regarding milestones, risks, and financial performance.
- Act as the primary project management contact for clients, supporting communication, scope alignment, and issue resolution.
- Manage project budgets, resource allocation, and financial reconciliation while identifying process improvements.
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