Gestionnaire des études cliniques internationales

Gestionnaire des études cliniques internationales at AbCellera

About the role At AbCellera, our mission is to break down barriers in the development of innovative therapies for patients in need. We are currently looking for a seasoned Clinical Study Manager to join our dynamic clinical operations team located in Montreal, Quebec. This position involves the comprehensive management of clinical studies from their initial planning stages through to completion, ensuring that all activities adhere to regulatory standards, protocols, and established operating procedures.

Key facts

Location: Montreal, Quebec

Engagement: Full-time

Team: Clinical Operations

What you'll do

• Lead the overall strategy for clinical studies, encompassing planning, execution, monitoring, and finalization phases.
• Ensure that clinical trials are executed in alignment with approved protocols, Good Clinical Practice (GCP), and relevant regulatory guidelines.
• Act as the main liaison for the Sponsor, coordinating with International Project Directors from contract research organizations and global functional leads.
• Partner with clinical project managers to convert global recruitment goals into actionable plans tailored for specific countries.
• Draft and evaluate study plans, protocols, and associated documentation while overseeing site selection, feasibility studies, and the creation of study materials.
• Guarantee adherence to regulatory standards and ethical practices, manage inspections and audits, and implement corrective measures as necessary.
• Create and oversee project timelines, milestones, and budgets, ensuring that deliverables are achieved within the established parameters.
• Identify potential risks associated with studies, develop strategies for risk mitigation, and proactively resolve issues as they arise.
• Supervise the collection, analysis, and presentation of data for clinical studies, ensuring data integrity, quality, and compliance with data protection laws.
• Prioritize the safety and well-being of participants by following adverse event reporting protocols and addressing safety concerns promptly.

Requirements

• A master's degree in a relevant discipline, with at least 6 years of proven experience as a regional project manager or clinical study manager. Candidates with a bachelor's degree and over 8 years of relevant experience will also be considered.
• In-depth understanding of Good Clinical Practice (GCP), regulatory frameworks, and clinical study management processes.
• Previous experience as a clinical research associate or within a research center is advantageous.
• Exceptional organizational and project management abilities, with a demonstrated capacity to prioritize tasks and meet tight deadlines.
• Bilingual proficiency with strong written and verbal communication skills, enabling effective collaboration with internal teams, external partners, and clinical researchers.
• Familiarity with clinical study management systems, electronic data capture systems, and other pertinent software tools.
• Certification in clinical research, such as ACRP or SOCRA, is an added benefit.

Nice to have

• Experience in managing international clinical trials.
• Knowledge of data analysis tools and methodologies.

Skills & tools

• Proficient in clinical study management systems
• Familiar with electronic data capture systems
• Experienced with project management software

Practical notes

Alongside a competitive base salary, we provide stock options, an annual performance-based bonus, and a 6% contribution to a retirement savings plan without requiring matching contributions. Additionally, you will receive an annual allowance of CAD 1,500 to support an active lifestyle, vacation time, flexible working hours, opportunities for professional development, and a comprehensive health care package. We prioritize scientific and technical mentorship, and our various initiatives, clubs, and social activities cultivate a strong sense of community among AbCellera employees.

Benefits and Perks

• a competitive base salary
• stock options
• an annual performance-based bonus
• a 6% contribution to a retirement savings plan without requiring matching contributions
• an annual allowance of CAD 1,500 to support an active lifestyle
• vacation time

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