Clinical Operations Manager
CanadaFull-TimeManager
Salary not disclosed
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Job Details
- Languages
- English
- Required Skills
- Project ManagementStakeholder management
Requirements
- Experience in clinical operations, clinical trial management, or related roles within a CRO or pharmaceutical environment.
- Strong understanding of ICH-GCP guidelines, clinical trial lifecycle, and local regulatory requirements in Canada.
- Experience managing study start-up activities, including regulatory submissions, ethics approvals, and site activation.
- Proven experience with clinical trial budgeting, contract negotiation (CTRA), and financial tracking.
- Strong organizational, coordination, and stakeholder management skills in a matrixed environment.
- Ability to influence internal and external stakeholders including investigators, vendors, and regulatory bodies.
- Excellent communication skills in English (French proficiency is an asset for Quebec-based operations).
- Strong problem-solving skills with the ability to proactively identify risks and implement mitigation strategies.
- Ability to work independently in a remote environment while managing multiple studies simultaneously.
- A proactive, detail-oriented mindset with strong accountability and time management skills.
Responsibilities
- Oversee country-level execution of assigned clinical trial protocols, ensuring timelines, quality standards, and regulatory compliance are met.
- Coordinate cross-functional stakeholders including CRAs, CRMs, legal, finance, regulatory, and vendors to ensure successful study delivery.
- Manage study start-up activities including site readiness, submissions, approvals, and ethics committee interactions.
- Own and support clinical trial budgeting and contract processes, including development, negotiation, and tracking of CTRAs.
- Monitor and reconcile study-related payments and ensure financial compliance and accuracy throughout the trial lifecycle.
- Support regulatory submissions and ensure compliance with local regulatory requirements and ICH-GCP guidelines.
- Oversee operational processes such as clinical supply coordination, documentation, archiving, and vendor management.
- Identify, assess, and mitigate risks impacting study timelines, quality, or compliance, escalating when required.
- Contribute to process improvements, training, and mentoring within the clinical operations team.
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