Senior Clinical Operations Manager
New
J
JobgetherClinical research
Home-based role open to candidates across CanadaFull-TimeManager
Salary not disclosed
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Job Details
- Languages
- Excellent written and spoken English
- Experience
- At least 10 years of clinical research experience
- Required Skills
- Microsoft ExcelQuality AssurancePowerPoint
Requirements
- Bachelor’s degree in clinical research or a related field.
- At least 10 years of clinical research experience in the biotechnology, pharmaceutical, or CRO industry.
- Experience in clinical monitoring and senior operational oversight as a Clinical Operations Manager, Project Manager, Clinical Trial Manager, or equivalent.
- Strong practical clinical monitoring experience and understanding of study management, site oversight, quality assurance, and clinical trial delivery.
- Good understanding of GCP and applicable regulations and guidelines from Health Canada, FDA, EMA, and other relevant regulatory authorities.
- Demonstrated ability to manage, coach, and develop clinical operations professionals and establish performance expectations.
- Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint.
- Ability to use AI-powered tools such as ChatGPT, Microsoft Copilot, Gemini, or similar platforms to improve workflows and productivity.
- Strong organizational, planning, time-management, multitasking, problem-solving, and analytical skills, including the ability to monitor performance metrics and manage competing priorities.
- Excellent written and spoken English and ability to communicate effectively with sponsors, clinical project teams, colleagues, and cross-functional stakeholders.
- Willingness to travel up to 20% of the time.
Responsibilities
- Oversee clinical monitoring and trial management activities across assigned teams, ensuring quality deliverables and compliance with timelines, budgets, SOPs, GCP, and study requirements.
- Lead, coach, and evaluate CRAs, CTMs, and other clinical operations professionals; support recruitment, onboarding, training, retention, succession planning, and professional development.
- Coordinate staffing and resource allocation across studies, balance workloads, and anticipate capacity requirements.
- Monitor operational KPIs, performance trends, productivity, and resource utilization, and help keep study activities within approved budgets.
- Collaborate with Project Management and Finance to identify financial or operational risks and implement mitigation strategies.
- Conduct or oversee Quality Assessment Visits, review site visit reports, identify quality concerns, and ensure corrective and preventive actions are implemented.
- Act as an escalation point for teams, sponsors, and stakeholders, resolving operational challenges and issues affecting study quality or delivery.
- Develop and implement training programs and identify opportunities to streamline workflows and improve operational effectiveness.
- Champion technology, automation, and AI-enabled solutions to improve productivity, oversight, decision-making, and clinical trial delivery.
- Build working relationships across clinical project teams and departments to align priorities, share expertise, and manage change.
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