About the role

Clinical Operations Manager overseeing regulatory submissions, budgets, and country start-up for Parexel’s clinical development services. Bilingual French-English role with two weekly days at Merck’s Montreal/Kirkland office.

Responsibilities

Ensure performance and compliance for assigned protocols with ICH/GCP, country regulations, client policies, quality standards, and adverse event reporting requirements
Oversee budget and finance aspects of country clinical trial submissions, approvals, and Site Ready activities
Manage country deliverables, timelines, and results for assigned protocols
Oversee Clinical Trial Coordinators as applicable
Coordinate with CRMs, CRAs, CTCs, Finance, Legal, headquarters, country operations, vendors, sites, IRB/IEC, and regulatory authorities
Support and oversee local vendors and local clinical processes
Coordinate clinical and ancillary supplies, import/export requirements, supplies destruction, filing, archiving, retention, and insurance processes
Enter and update country information in clinical and finance systems
Deliver clinical and financial contracts within fair market value
Execute and oversee clinical trial country submissions and approvals
Develop local-language materials, informed consents, and translations
Interact with IRB/IEC and regulatory authorities
Lead or contribute to business initiatives and projects
Act as a process SME, share best practices, make continuous-improvement recommendations, and provide training
Mentor team members and share best practices

Candidates must be bilingual (French and English)
Must be able to go to the Merck office in Montreal, Kirkland, 2 days per week
5-7 years clinical research or combined experience in Clinical Research and Business
Expertise of core clinical, regulatory, and financial systems, tools, and metrics
Bachelor's Degree in Business Finance/Administration/Life Science or equivalent Health Care related experience
Strong coordination and organizational skills
Knowledge of budget and contract negotiations, local regulatory environment, and submission and approval processes
Ability to influence investigators, vendors, external partners, country managers, and site staff
Ability to make decisions independently with limited oversight
Ability to develop risk management and mitigation plans and resolve issues locally
Ability to lead a team of Clinical Trial Coordinators as applicable
Problem-solving, root-cause analysis, and solution-proposal skills
Effective time management, organizational, interpersonal, and conflict management skills
Strong communication, leadership, negotiation, influencing, training, and mentoring skills
Ability to manage multiple deliverables and protocols simultaneously
Ability to work effectively in a remote virtual environment
Positive mindset, growth mindset, independence, and self-drive
Excellent verbal and written influencing and training/mentoring skills in French and English