ClinicalOperationsManager-FSP

## Accountabilities 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. 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 s