This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Clinical Operations Manager, Gestionnaire des opérations cliniques in Canada.
This role is central to ensuring the successful execution of clinical trials through strong operational leadership, team management, and quality oversight. You will lead and support a team of Clinical Research Associates and clinical operations personnel, ensuring high-quality monitoring activities are delivered on time, within budget, and in full compliance with GCP, SOPs, and regulatory standards. Acting as both a people leader and operational expert, you will drive performance, coaching, and continuous improvement across your team. You will also play a key role in resource allocation, issue resolution, and stakeholder coordination across clinical projects. In a fast-paced CRO environment, you will help ensure operational excellence while fostering innovation and the adoption of modern tools, including AI-enabled solutions. This is a highly collaborative role with direct impact on study quality, site relationships, and overall trial success.
Accountabilities:
- 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.
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.
Benefits:
- Permanent full-time remote position across Canada
- Flexible work arrangements (home-based or hybrid depending on preference)
- Comprehensive benefits package including health, dental, and vision coverage
- Paid vacation and personal days
- Retirement savings plan and additional insurance coverage options
- Continuous learning and professional development opportunities
- Access to wellness programs and employee support initiatives
- Public transit and commuting discounts where applicable
- Social and team engagement activities