Description:
ICON plc, a leading healthcare intelligence and clinical research organization, is seeking a Clinical Operations Manager - Finance in Montreal. The role involves ensuring performance and compliance for assigned protocols in a country, following ICH/GCP and country regulations, sponsor policies, and quality standards. Responsibilities include managing budget/finance aspects, overseeing clinical trial country submissions and approvals, and ensuring Site Ready.
Responsibilities include, but are not limited to:
Ownership of country and site budgets.
Development, negotiation, and completion of Clinical Trial Research Agreements (CTRA).
Overseeing and tracking clinical research-related payments.
Payment reconciliation at study closeout.
Overseeing FCPA, DPS/OFAC, and maintenance of financial systems.
Financial forecasting in conjunction with Sr.COM /other roles.
Executing and overseeing clinical trial country submissions and approvals.
Developing local language materials including local language Informed Consents and translations.
Interacting with IRB/IEC and Regulatory Authority for assigned protocols.
Managing country deliverables, timelines, and results for assigned protocols.
Contributing to the development of local SOPs.
Coordinating and liaising with various internal and external stakeholders.
Providing support and oversight to local vendors.
Overseeing and coordinating local processes, supplies management, and insurance process management.
Ownership of local regulatory and financial compliance.
Influencing investigators, external partners, and country operations.
Working in partnership with internal and external stakeholders.
Contributing to initiatives and projects adding value to the business.
Acting as process Subject Matter Expert (SME) and providing training.
Acting as buddy/mentor and sharing best practices.
What you need to have:
Bachelor's Degree in Business Finance/Administration/Life Science or equivalent Health Care related experience.
5 years of experience in clinical research or combined experience in Clinical Research and Finance/Business.
Expertise of core clinical systems, tools, and metrics.
Excellent verbal and written influencing and training/mentoring skills in French and English.
Strong coordination and organizational skills.
Skilled knowledge of budget and contract negotiations, local regulatory environment, and submission and approval processes.
Ability to make decisions independently with limited oversight.
Strong understanding of local regulatory environment.
Ability to proactively develop risk management and mitigation plans.
Eligible to work in Canada without visa sponsorship.
ICON offers competitive salary, various benefits, and a diverse culture that rewards high performance. Inclusion and belonging are fundamental to the company's values. If you require a reasonable accommodation for the application process, please let us know. Even if you don't meet all requirements, we encourage you to apply as you may be the perfect fit for the role.
