Clinical Study Manager

Clinical Study Manager Join to apply for the Clinical Study Manager role at AbCellera. AbCellera’s platform integrates biology, computation, and engineering to develop impactful antibody‑based medicines. We’re scientists, engineers, and business professionals working together to turn scientific insights into breakthrough medicines. We pursue truth and scientific rigor, think independently, act with conviction, and push the edge of the unknown. We offer opportunities to stretch and explore, and to work on meaningful science. We are seeking a highly motivated and detail‑oriented Clinical Study Manager (CSM) to join our growing clinical operations team based in Montreal, Quebec. The CSM will plan, lead, and oversee clinical trials from start‑up through to completion, ensuring efficient and timely execution of clinical studies in compliance with regulatory requirements, protocols, and SOPs. In this role, you will collaborate with cross‑functional teams—including CRAs, data managers, clinical monitors, and regulatory personnel—to deliver high‑quality clinical data while staying within budget and timelines. How you might spend your days Overseeing all aspects of clinical trials, including study planning, execution, monitoring, and close‑out, ensuring that clinical studies are conducted in accordance with the approved protocol, GCP, and applicable regulations Serving as a liaison between the clinical team and external stakeholders such as vendors, CROs, and investigators Managing relationships with external vendors and service providers, ensuring quality standards are met and timelines for deliverables such as recruitment, data management, and site monitoring are met or exceeded 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 to address challenges, and resolving issues proactively Overseeing the collection, analysis, and reporting of clinical trial data, ensuring data integrity and quality, accurate data handling, and compliance with data protection regulations 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 minimum of 8 years of demonstrated work experience as a Clinical Project Manager or Clinical Study Manager, in addition to a Bachelor’s degree You have strong working knowledge of GCP, regulatory requirements, and clinical trial management 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 have early phase clinical trial experience across multiple therapeutic areas (desirable) You have the ability to manage CROs, external vendors, and engage in contract negotiations Effective communication, organizational and project management skills are a real strength You think strategically and collaborate effectively across teams You are proficient in CTMS, EDC systems, and other relevant software You are comfortable traveling to sites, CROs, and our Vancouver headquarters as needed What we offer In addition to base salary, we offer equity, annual bonus dependent on team and company performance, and a 6% (non‑match) RRSP contribution. You will have a CAD $1,500 annual Active Lifestyle Allowance, annual vacation, flexible work arrangements, professional development opportunities, and comprehensive health benefits. Scientific and technical mentorship is a priority. We prioritize teams and social groups to build community and connections across AbCellera. About AbCellera AbCellera is a global company that discovers and develops antibody‑based medicines that help people live longer, happier, and more productive lives. We focus on bringing innovative medicines to patients by advancing our internal pipeline and partnering with companies with novel science or technology. We build a place where people feel part of something bigger, pushing limits of science and technology to bring better therapies. To apply Please submit your application through our website and refer to Job ID 23321 in your cover letter. We apologize in advance, but we receive a large volume of applications and can only contact those selected for an interview. Seniority level Mid‑Senior level Employment type Full‑time Job function Research, Analyst, and Information Technology #J-18808-Ljbffr