# Clinical Operations Manager

**Company**: Fortrea
**Location**: Montreal, QC
**Work arrangement**: hybrid
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Montreal/Clinical-Operations-Manager--COM-_264999?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_34e49651-a3c

## Description

Fortrea's FSP team is seeking a Clinical Operations Manager in Montreal, Canada, to oversee local operational clinical trial activities, ensuring regulatory and financial compliance.

The successful candidate will have strong organisational skills, attention to detail, and the ability to manage financial processes effectively.

**Job Overview:** The Clinical Operations Manager will be accountable for the execution and oversight of local operational clinical trial activities, with ownership of local regulatory and financial compliance at a country operations level.

**Key Responsibilities:**

- Financial management: assistance with country and site budgets, delivering clinical and financial contracts, tracking payments, and reconciling payments at study close-out.

- Country submissions and local language materials: responsible for country submissions and approvals, development of local language materials, including informed consents and translations.

- Management and quality oversight: manages country deliverables, timelines, and results, contributes to local SOPs development.

- Collaboration: works closely with internal teams, vendors, sites, IRB/IECs, and regulatory authorities to ensure country deliverables are met.

- Local process oversight: responsible for clinical and ancillary supplies management, importing and exporting requirements, and insurance process management.

**Requirements:**

- University/college degree in life sciences or a related field, or certification in a related allied health profession.

- Minimum 4-6 years of clinical research experience in the pharmaceutical or CRO industry.

- Thorough knowledge of ICH guidelines and GCP, including regulatory requirements in other countries.

- Fluent in French and English, both written and verbal.

**Preferred Qualifications:**

- Good organisational and time management skills.

- Working knowledge of ICH, FDA, local regulatory requirements, and IRB/IEC regulations.

- Excellent communication skills, oral and written.

- Self-motivated with the ability to work under pressure to meet deadlines.

- Detail-oriented and process-oriented.

- Positive attitude and approach.

- Ability to interact with internal and external customers with a high degree of professionalism and discretion.

- Multi-tasking capability.

- Good computer skills with a range of computer packages.

- Ability to lead and develop junior staff.

- Flexible and adaptable to a developing work environment.

## Skills

### Required
- ICH guidelines
- GCP
- regulatory compliance
- financial management
- clinical trial operations
- French
- English

### Nice to have
- organisational skills
- time management
- communication skills
- leadership

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Source: [Apply at fortrea.wd1.myworkdayjobs.com](https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Montreal/Clinical-Operations-Manager--COM-_264999?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)