Clinical Operations Manager
Permanent full-time remote position across CanadaFull-TimeManager
Salary not disclosed
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Job Details
- Languages
- English, French
- Experience
- Minimum of 6 years
- Required Skills
- Project ManagementGCP
Requirements
- Bachelor’s degree in a scientific, healthcare, or clinical research-related field.
- Minimum of 6 years of experience in clinical research within pharmaceutical, biotechnology, or CRO environments.
- At least 4 years of experience as a Senior CRA or 2+ years in a Clinical Trial Manager, Project Manager, or equivalent leadership role.
- Strong hands-on experience in clinical monitoring and site management activities.
- Solid knowledge of Good Clinical Practice (GCP), Health Canada, FDA, and EMA regulatory frameworks.
- Proven leadership experience managing teams, performance, and cross-functional collaboration.
- Strong organizational, problem-solving, and communication skills in fast-paced environments.
- Experience with digital tools, process optimization, and familiarity with AI-enabled productivity solutions.
- Ability to manage multiple priorities and travel up to 20% as required.
- Adaptability, curiosity, and a strong commitment to innovation and continuous improvement.
Responsibilities
- Lead and manage a team of Clinical Research Associates and clinical operations staff, overseeing performance, training, and professional development.
- Ensure clinical monitoring activities are delivered according to protocols, regulatory requirements, SOPs, and sponsor expectations.
- Allocate resources across clinical projects to ensure optimal coverage, efficiency, and timely delivery of study milestones.
- Monitor key operational metrics and implement corrective actions to address gaps in performance or compliance.
- Conduct quality assessment visits and oversee audit readiness, ensuring continuous compliance with GCP and internal standards.
- Identify, document, and resolve operational quality issues, developing action plans and driving their execution.
- Serve as a key escalation point for clinical operations issues involving sites, sponsors, and internal teams.
- Contribute to recruitment, interviewing, and onboarding of new clinical operations talent.
- Support process optimization initiatives and foster continuous improvement across clinical workflows.
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