FSP Clinical Operation Manager- Finance Hybrid, Montreal

Fortreas FSP team is hiring a Clinical Operation Manager- Finance - Hybrid in Montreal Canada. Must be bilingual in French & English.

Job Overview:

This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations policies and procedures quality standards and adverse event reporting requirements internally and externally.

Under the oversight of the Line Manager the person is responsible for budget/finance aspects for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.

Summary of Responsibilities:

Development negotiation and completion of Clinical Trial Research Agreements (CTRA).

Oversees FCPA DPS/OFAC and maintenance of financial systems. Financial forecasting in conjunction with / other roles.

Executes and oversees clinical trial country submissions and approvals for assigned protocols.

Manages country deliverables timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country.

Contributes to the development of local SOPs. Oversees CTCs as applicable.

Coordinates and liaises with CRM CTC CRA (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions budgets CTRAs and local milestones.

Collaborates closely with Headquarter to align country timelines for assigned protocols.

Oversees and coordinates local processes 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 and finance systems.

Ownership of local regulatory and financial compliance. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up.

Required to in/directly influence investigators external partners and country operations to adheres to budget targets and agreed payment timelines.

Works in partnership internally with GCTO country operations finance regulatory affairs pharmacovigilance legal and regional operations HQ functional areas and externally with vendors and sites IRB/IECs and Regulatory Authorities in submission and approval related- interactions. Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.

Contribute or lead initiatives and projects adding value to the business

Contributes strongly to COM team and other Country Operations roles knowledge by acting as process Subject Matter Expert (SME) sharing best practices making recommendations for continuous improvement and providing training as appropriate/required.

Contributes to COM team knowledge by acting as buddy/mentor and sharing best practices as appropriate/required

• And all other duties as needed or assigned.

Qualifications (Minimum Required):

• Bachelors Degree in Business Finance/Administration/Life Science or equivalent Health Care related experience.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• 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 French and English both written and verbal
• Hybrid role (2-3 days/week at the office)

Experience (Minimum Required):

• Good organizational and time management skills.
• Working knowledge of ICH 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.
• High sense of accountability and urgency in order to properly prioritize deliverables
• Strong leadership and negotiation skills
• 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.

Learn more about our EEO & Accommodations request here.