Description
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a Clinical Operations Manager - Regulatory, you will be accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, sponsor policies and procedures, quality standards and adverse event reporting requirements internally and externally.
Responsibilities:
- Ownership of country and site budgets, development, negotiation and completion of Clinical Trial Research Agreements (CTRA)
- Oversee and track clinical research-related payments, payment reconciliation at study closeout, and financial forecasting
- Execute and oversee clinical trial country submissions and approvals for assigned protocols
- Develop local language materials, including local language Informed Consents and translations
- Manage country deliverables, timelines and results for assigned protocols to meet country commitments
- Contribute to the development of local SOPs and oversee CTCs as applicable
- Coordinate and liaise with CRM, CTC, CRA, Finance and Legal to ensure country deliverables are obtained
- Collaborate closely with Headquarters to align country timelines for assigned protocols
- Provide support and oversight to local vendors as applicable
- Oversee and coordinate local processes, clinical and ancillary supplies management, importing and exporting requirements, and insurance process management
- Ownership of local regulatory and financial compliance
Requirements:
- 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 indirectly influence investigators, vendors, external partners and country managers to address and resolve issues
- Ability to make decisions independently with limited oversight
- Requires strong understanding of local regulatory environment
- Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally
- Eligible to work in Canada without visa sponsorship
Rewards & Benefits:
- Competitive base salary and performance-related incentives
- Health and wellbeing programmes, including medical, dental, and vision coverage
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways