# Clinical Operations Manager - Regulatory

**Company**: ICON
**Location**: Montreal, QC
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/Canada-Montreal/Clinical-Trial-Manager_JR159477?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_d3deeec1-f00

## 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

## Skills

### Required
- clinical research
- regulatory compliance
- budgeting
- contract negotiation
- French
- English

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Source: [Apply at icon.wd3.myworkdayjobs.com](https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/Canada-Montreal/Clinical-Trial-Manager_JR159477?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)