Clinical Operations Manager

Fortrea

. Execute and oversee local operational clinical trial activities at the country level .

Posted 9/28/2026full-timeMontreal • CanadaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing local operational clinical trial activities, ensuring regulatory compliance, and delivering on country-specific trial commitments. Proficient in budget management, contract negotiations, and collaboration with various stakeholders in the clinical research environment.

Highest-signal resume keywords

Clinical Research ExperienceRegulatory ComplianceBudget ManagementFluent in French and EnglishICH Guidelines Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ManagementRegulatory Submission ProcessesRisk ManagementBudget NegotiationGCP KnowledgeDrug Development ProcessLocal Regulatory RequirementsInvestigator Start-Up DocumentsClinical Research Payments ManagementSOP Development

Soft Skills

Excellent Communication SkillsOrganizational SkillsTime ManagementDetail-OrientedMultitasking Capability

Tools & Technologies

Clinical SystemsRegulatory SystemsSafety SystemsFinance SystemsComputer Packages

Certifications & Qualifications

University/College Degree in Life ScienceNursing CertificationMedical Technology Certification

Industry Keywords

Pharmaceutical IndustryCRO IndustryIRB/IECICHFDAClinical OperationsCompliancePharmacovigilanceHealth Care SettingLocal Ethics

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Execute and oversee local operational clinical trial activities at the country level
Own and oversee local regulatory and financial compliance
Deliver country-specific trial commitments and objectives, especially during study start-up
Influence investigators, vendors, external partners, and country managers to meet commitments
Adhere to budget targets and payment timelines
Address and resolve issues locally
Maintain expertise in country-based regulations, laws, and procedures
Support budget and contract negotiations
Manage local ethics, legislation, regulatory environment, submission and approval processes
Develop local-language informed consents and other site-ready and ongoing study deliverables
Develop risk management and mitigation plans
Assist with country and site budgets and deliver clinical and financial contracts
Oversee and track clinical research-related payments and reconcile payments at study close-out
Execute and oversee country submissions and approvals for assigned protocols
Work with IRB/IEC and Regulatory Authorities on submission and approval interactions
Manage country deliverables, timelines, and results for assigned protocols
Contribute to local SOP development
Collaborate with clinical operations, quality, finance, medical, regulatory, pharmacovigilance, compliance, legal, regional, vendor, site, IRB/IEC, and regulatory teams
Align country timelines with Regional Operations and oversee local vendors
Manage clinical and ancillary supplies, import/export requirements, supplies destruction, filing, archiving, retention, and insurance processes
Enter and update country information in clinical, regulatory, safety, and finance systems
Perform other assigned duties

Requirements

What you’ll need

University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology
Relevant and equivalent experience may be considered in lieu of educational requirements
Minimum of four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries or experience in a health care setting may substitute for the educational requirement
Thorough knowledge of ICH Guidelines and GCP
Basic understanding of regulatory requirements in other countries
Thorough understanding of the drug development process
Fluent in French and English, both written and verbal
Good organizational and time management skills
Working knowledge of ICH, FDA, local regulatory requirements, IRB/IEC and other applicable regulations/guidelines
Familiarity with investigator start-up documents
Previous interaction with operational project teams and investigative sites preferred
Excellent oral and written communication skills
Ability to work under pressure and meet deadlines
Ability to work independently and in a team environment
Detail- and process-oriented
Ability to interact professionally and discreetly with internal and external customers
Multitasking capability
Good computer skills and working knowledge of a range of computer packages
Ability to lead and develop junior staff
Flexibility and adaptability to a developing work environment
Minimum of four-six (4–6) years of clinical research experience

Benefits

Comp & perks

Hybrid work arrangement in the Montreal office 2–3 days per week
Equal employment opportunity and accommodations support