Clinical Operations Manager (COM) - Montreal, Canada - Hybrid
- Montreal, QC, Canada
Full-time
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Job details
- Job type
- Full-time
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- Posting language
- English
- Posted
Original job description
Fortrea's FSP team is hiring a Clinical Operations Manager in Montreal, Canada
Must be bilingual in French & English
Candidates with strong organizational skills, attention to details, and the ability to manage financial processes effectively will be particularly well suited for the role
Hybrid role in Montreal office 2-3 days per week
Job Overview
Accountable for execution and oversight of local operational clinical trial activities and has ownership, oversight, and impact on local regulatory and financial compliance, at a country operations level at the client. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up. The ability to indirectly influence investigators, vendors, external partners, and country managers to deliver these commitments is a must. This includes adhering to budget targets and agreed payment timelines, addressing and resolving issues, maintaining expertise in country-based regulations, laws and procedures with minimal support from the client management. Requires skilled knowledge of budget and contract negotiations, the local ethics, legislation and regulatory environment, submission and approval processes, development of local Informed Consent as well as other site ready and ongoing study deliverables. Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.
Summary Of Responsibilities
Must be bilingual in French & English
Candidates with strong organizational skills, attention to details, and the ability to manage financial processes effectively will be particularly well suited for the role
Hybrid role in Montreal office 2-3 days per week
Job Overview
Accountable for execution and oversight of local operational clinical trial activities and has ownership, oversight, and impact on local regulatory and financial compliance, at a country operations level at the client. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up. The ability to indirectly influence investigators, vendors, external partners, and country managers to deliver these commitments is a must. This includes adhering to budget targets and agreed payment timelines, addressing and resolving issues, maintaining expertise in country-based regulations, laws and procedures with minimal support from the client management. Requires skilled knowledge of budget and contract negotiations, the local ethics, legislation and regulatory environment, submission and approval processes, development of local Informed Consent as well as other site ready and ongoing study deliverables. Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.
Summary Of Responsibilities
- FINANCIAL (as applicable):
- Assistance with the ownership of country and site budgets.
- Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.
- Oversight and tracking of clinical research-related payments.
- Payment reconciliation at study close-out.
- COUNTRY SUBMISSIONS and LOCAL LANGUAGE MATERIALS (as applicable):
- Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols.
- Development of local language materials including local language Informed Consents and translations.
- Works in partnership with IRB/IEC and Regulatory Authority in submission and approval related interactions for assigned protocols.
- MANAGEMENT and QUALITY OVERSIGHT:
- Responsible for managing country deliverables, timelines, and results for assigned protocols to meet country commitments.
- Contributes to the development of local SOPs.
- COLLABORATION:
- Works in close collaboration internally with Clinical country operations (CRD, CRM, CTC, CRA), Country Quality Manager (CQM), Finance, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Business Compliance, Legal and regional operations, Head Quarter functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.
- Collaborates closely with Regional Operations to align country timelines for assigned protocols. Provides support and oversight to local vendors as applicable.
- LOCAL PROCESS OVERSIGHT: (as applicable):
- Responsible for clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management.
- Enters and updates country information in clinical, regulatory, safety and finance systems.
- And all other duties as needed or assigned.
- 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.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
- In lieu of the above requirement, candidates with a minimum of four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries or experience in a health care setting will be considered.
- Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries
- Thorough understanding of the drug development process
- Fluent in local office language and in 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 team and investigative sites preferred.
- Excellent communication skills, oral and written.
- Self-motivation with the ability to work under pressure to meet deadlines. Works well independently and in a team environment.
- Detail and process oriented.
- Positive attitude and approach.
- Interact with internal and external customers with a high degree of professionalism and discretion.
- Multi-tasking capability.
- Good computer skills with good working knowledge of a range of computer packages.
- Ability to lead and develop junior staff.
- Flexible and adaptable to a developing work environment.
- Minimum of four-six (4-6) years of clinical research experience.
More about this job
Responsibilities
Oversee country-level clinical trial operations, submissions, approvals, budgets, contracts, payments, timelines, and regulatory compliance. Coordinate with internal teams, sites, vendors, ethics committees, and regulatory authorities to deliver country commitments and manage local processes and risks.
Requirements
Requires a degree or relevant equivalent experience, at least 4–6 years of clinical research experience, and thorough knowledge of ICH, GCP, and applicable regulatory requirements. Candidates must be fluent in French and English and demonstrate strong organization, communication, time management, attention to detail, and the ability to work independently and lead junior staff.
Skills
- Clinical Trial Operations
- Country Submissions and Approvals
- Financial Oversight
- ICH Guidelines
- Good Clinical Practice
- Regulatory Compliance
- Informed Consent Development
- Risk Management
- Project and Timeline Management
- Vendor Oversight
- Payment Reconciliation
- Cross-Functional Collaboration
- Local Language Materials
- Staff Leadership
- Organizational Skills
Visa sponsorship
Not detected in the job text
Categories
- Healthcare
- Management & Leadership
- Science & Research
- Finance & Accounting
- Legal
Keywords
- Clinical Operations
- Clinical Research
- Clinical Trials
- ICH Guidelines
- Good Clinical Practice
- Regulatory Requirements
- Country Submissions
- Regulatory Approvals
- IRB/IEC
- Informed Consent
- Budget Management
- Contract Negotiation
- Fair Market Value
- Clinical Research Payments
- Payment Reconciliation
- Risk Management
- Standard Operating Procedures
- Study Start-Up
- Investigator Start-Up Documents
- Vendor Management
- Site Management
- Clinical Trial Agreements
- Local Language Translations
- Clinical Supplies Management
- Import and Export Requirements
- Archiving and Retention
- Regulatory Compliance
- Pharmaceutical Industry
- CRO
- French and English