Clinical Operations Manager-FSP
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.
- 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.
- 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).