Global Clinical Study Manager

Benefits

Additional Information

Each of us cares about someone who will need medicines. That's why our vision is to repeatedly beat the odds to deliver breakthrough medicines to patients that need them. We pursue truth and scientific rigour and have the courage to work at the edge of the unknown. We are seeking a highly motivated and experienced Clinical Study Manager (CSM) to lead and manage clinical trials from start-up through to completion. Based out of Montréal, Québec, the Clinical Study Manager will ensure the efficient and timely execution of clinical studies in compliance with regulatory requirements, protocols, and standard operating procedures (SOPs). In this role, you will collaborate with cross-functional teams, including clinical research associates (CRAs), data managers, and regulatory personnel, to deliver high-quality clinical data while maintaining adherence to the budget and timelines. How you might spend your days: Overseeing the global strategy of clinical trials, including study planning, execution, monitoring, and close-out Ensuring clinical studies are conducted in accordance with the approved protocol, Good Clinical Practice (GCP), and applicable regulations Acting as the primary Sponsor contact for Global CRO Project Directors and Global functional leads Partnering with Clinical Project Managers (CPMs) to translate global recruitment targets into country-specific execution plans Developing and reviewing study plans, protocols, and related documents, while overseeing site selection, feasibility assessments, and the development of study materials Ensuring studies adhere to regulatory requirements and ethical standards, handling regulatory inspections and audits, and implementing corrective actions when necessary Developing and managing project timelines, milestones, and budgets, ensuring all deliverables are met within the agreed-upon timeframe and budget Identifying potential risks to the study, developing mitigation strategies, and taking appropriate action to resolve issues as they arise during the course of the study Overseeing the collection, analysis, and reporting of clinical trial data, ensuring data integrity and quality, accurate data handling, and compliance with data protection regulations Monitoring and ensuring the safety and welfare of study participants by adhering to safety reporting guidelines and promptly addressing any safety concerns We'd love to hear from you if: You have a Master's degree in a relevant field, and 6+ years of demonstrated work experience as a Regional Clinical Project Manager or Clinical Study Manager; candidates with a Bachelor's degree and 8+ years of related experience will also be considered You have strong working knowledge of Good Clinical Practice (GCP), regulatory requirements, and clinical trial management You have previous experience as a CRA, or experience working at clinical sites You have strong organizational and project management skills, with the ability to prioritize and manage competing deadlines You are bilingual with excellent communication skills, both written and verbal, and have the ability to collaborate effectively with internal teams, external vendors, and clinical investigators You are proficient in clinical trial management systems (CTMS), electronic data capture (EDC) systems, and other relevant software You are certified in Clinical Research, such as ACRP, SOCRA (desirable)

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Company Intel

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