Senior Clinical Operations Manager, Canada/USA, remote
Core
Line management and performance oversight of Clinical Operations personnel (CRAs, CTMs) to ensure high-quality, compliant, and efficient clinical monitoring and trial management services.
Role type
Senior Clinical Operations Manager (IC)
Builds
Clinical monitoring and trial management services for sponsors in dermatology and rheumatology
Domain
Biotechnology / Pharmaceutical / CRO / Clinical Research
Required skills
Line management, performance oversight, resource planning, budget monitoring, quality governance, risk management, change management, regulatory knowledge (GCP, FDA, Health Canada, EMA), AI tool proficiency
Preferred skills
Experience in CRO, innovation in clinical operations, digital transformation
Technologies
Microsoft Office suite, AI-powered tools (ChatGPT, Microsoft Copilot, Gemini)
Responsibilities
Provide line management and performance oversight for Clinical Operations personnel; Ensure clinical monitoring and trial management activities meet Sponsor's satisfaction and regulatory requirements; Support hiring, onboarding, training, and succession planning; Oversee resource planning and allocation; Track Clinical Operations metrics and monitor adherence to targets; Ensure activities are executed within approved study budgets; Partner with Project Management and Finance to identify risks; Perform or oversee Quality Assessment Visits (QAVs); Drive innovation and adoption of technology and AI-enabled solutions
Seniority
Senior, hands-on IC