This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Clinical Operations Manager-FSP based in Canada.
This is a highly impactful clinical operations role focused on driving the successful execution of clinical trials at the country level, with a strong emphasis on study start-up, regulatory compliance, and financial oversight. You will coordinate cross-functional clinical activities to ensure trials are delivered on time, within budget, and in full compliance with ICH-GCP and local regulatory requirements. The role blends operational leadership with financial and regulatory responsibility, requiring close collaboration with internal teams, investigators, vendors, and ethics committees. You will play a key role in ensuring site readiness, managing contracts and budgets, and supporting high-quality study execution across multiple protocols. With significant autonomy, you will influence stakeholders across the clinical ecosystem while maintaining strict compliance and quality standards. This position is ideal for a detail-oriented clinical operations professional who thrives in a fast-paced, matrixed, and remote-first environment.
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 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.
Benefits:
- Competitive compensation aligned with clinical operations leadership roles
- Remote-first work environment within Canada, with flexible collaboration
- Opportunity to contribute to global clinical trials improving patient access to therapies
- Exposure to complex, multi-stakeholder clinical research programs
- Career development within a leading global clinical research organization
- Collaborative, mission-driven culture focused on innovation and patient impact
- Comprehensive benefits package including healthcare and retirement support (where applicable).
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
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