Global Clinical Study Manager at AbCellera.About the role AbCellera is looking for a dedicated Clinical Study Manager to oversee the entire lifecycle of clinical trials, from initial planning and setup through to close-out and reporting. This role involves ensuring that all aspects of clinical studies are conducted in compliance with regulatory standards, Good Clinical Practice, and internal protocols. The Clinical Study Manager will coordinate closely with internal teams, external partners such as CROs, and clinical sites to ensure smooth execution of trials, high-quality data collection, and participant safety. The position requires a strategic thinker with strong project management skills, capable of managing multiple complex projects simultaneously. The role is based on-site in Montreal, Quebec, and offers an chance to work within a dynamic, innovative biotech environment committed to advancing therapeutic discoveries.Key factsLocation: Montreal, QuebecEngagement: Full-timeWhat you'll doLead the development and implementation of global clinical trial strategies, including planning, monitoring, and execution phases, ensuring alignment with company goals and regulatory requirements.Oversee the preparation and review of study protocols, case report forms, and other essential trial documentation.Manage the selection, qualification, and oversight of external vendors, including CROs, ensuring they meet project standards and timelines.Serve as the main point of contact for global CRO Project Directors, functional leads, and internal teams involved in clinical studies.Collaborate with Clinical Project Managers to translate global recruitment and enrollment goals into detailed site-level plans and activities.Coordinate with clinical sites to facilitate study initiation, conduct, and close-out activities, including site training and monitoring visits.Ensure all study activities adhere to Good Clinical Practice, local regulations, and internal quality standards.Manage regulatory submissions, including ethics committee submissions and regulatory authority filings, ensuring timely approvals.Prepare and review study-related documents such as protocols, amendments, informed consent forms, and monitoring plans.Oversee the conduct of regulatory audits and inspections, preparing documentation and implementing corrective actions when necessary.Track project budgets, timelines, and milestones,



proactively identifying potential delays or issues and implementing corrective measures.Monitor study progress through regular review of site reports, monitoring visit reports, and data quality metrics.Identify potential risks or issues in clinical trials early and develop mitigation strategies to address them.Oversee data collection, management, and reporting to ensure integrity, accuracy, and compliance with regulatory standards.Ensure participant safety by monitoring adverse events, reporting safety concerns according to guidelines, and addressing participant issues promptly.Facilitate communication among all stakeholders, including investigators, vendors, and internal teams, to ensure transparency and alignment.Contribute to continuous improvement initiatives in clinical trial processes, tools, and documentation practices.Support training and mentoring of junior staff or new team members as needed.Maintain up-to-date knowledge of industry trends, regulatory changes, and best practices in clinical trial management.RequirementsMaster's degree in a relevant scientific or healthcare field, such as life sciences, pharmacy, or related disciplines, plus at least 6 years of experience managing clinical trials or projects.Alternatively, a Bachelor's degree with a minimum of 8 years of relevant experience in clinical trial management.Proven experience managing global clinical trials, preferably in biotech or pharmaceutical settings.Deep understanding of clinical trial processes, regulatory requirements, and Good Clinical Practice guidelines.Experience working directly at clinical sites or as a Clinical Research Associate is highly desirable.Strong project management skills, with the ability to coordinate multiple projects, prioritize tasks, and meet deadlines.Excellent communication skills, with proficiency in English and bilingual capabilities to liaise effectively with investigators, vendors, and internal teams.Demonstrated ability to manage vendor relationships and oversee external CROs.Proficiency with Electronic Data Capture (EDC)



systems and Clinical Trial Management Systems (CTMS).Knowledge of regulatory submission processes, including ethics submissions and regulatory authority interactions.Ability to analyze data, identify issues, and develop solutions proactively.Strong organizational skills and attention to detail.Ability to adapt to changing priorities and work in a fast-paced environment.Experience with audit preparation and regulatory inspections.Knowledge of ICH-GCP guidelines and local regulatory requirements.Nice to haveCertification in Clinical Research, such as SOCRA or ACRP, which demonstrates additional expertise and commitment to professional development.Experience working in a biotech or innovative research environment.Familiarity with ITAR regulations or experience working with international regulatory standards.Knowledge of risk management strategies specific to clinical trials.Experience managing clinical trials involving complex or novel therapeutic modalities.Skills & toolsClinical Trial Management Systems (CTMS)Electronic Data Capture (EDC) systemsProject management skillsRegulatory compliance expertiseVendor managementData analysis and reportingCommunication and stakeholder managementDocumentation and protocol developmentPractical notesCompensation package includes a competitive base salary, equity options, and an annual performance-based bonus.Benefits include a 6% non-matching RRSP contribution, a CAD $1,500 annual Active Lifestyle Allowance, comprehensive health coverage, and paid annual vacation.The company promotes flexible work arrangements and supports professional development initiatives.The application process may involve multiple interview stages, including technical and behavioral assessments.Only candidates selected for interviews will be contacted; official communication will originate from an @abcellera.Com email address.The role requires on-site presence in Montreal, Quebec, with no remote work option specified.The company values diversity and encourages applications from qualified candidates regardless of background.Candidates should be prepared to demonstrate their experience with clinical trial management, regulatory compliance, and vendor oversight during the interview process.The role involves working in a fast-paced, innovative environment dedicated to advancing therapeutic research and development. #J-18808-Ljbffr

📌 Global Clinical Study Manager (Montreal)
🏢 AbCellera
📍 Montreal