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 biopharma sponsors
Domain
Clinical Research / Biotechnology / Pharmaceutical / CRO
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
CRO experience, innovation adoption, digital transformation, coaching and mentorship
Technologies
Microsoft Office suite, AI-powered tools (ChatGPT, Microsoft Copilot, Gemini)
Responsibilities
Ensure clinical monitoring and trial management activities meet sponsor satisfaction and regulatory requirements; Provide line management and performance oversight for Clinical Operations personnel; Support hiring, onboarding, training, and succession planning; Oversee resource planning and allocation across studies; 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 continuous improvement including technology and AI adoption
Seniority
Senior, hands-on IC