Global Clinical Study Manager

Job description

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 8+ years of demonstrated work experience in clinical study management, in addition to a Bachelor’s degree in a related field - 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 (asset) - 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) **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, opportunity for flexible work arrangements, professional development opportunities, and comprehensive health benefits. Scientific and technical mentorship is a priority. And you’ll find a strong sense of community and connections across AbCellera through our work, clubs, and socials. **About AbCellera** ***Creating medicines is the most important work we can do.*** We are a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology, women’s health, immunology, and oncology. We have built a platform for advancing antibody drug programs from target to clinic, and we are using it to build our internal pipeline. Today, our pipeline includes two drug candidates in clinical development, two preclinical development candidates (DCs) in Investigational New Drug (IND)-enabling activities, and more than 20 active discovery programs across multiple modalities and indications. We believe that when tenacious people share a vision and work together, they can truly have a positive impact. That’s why we hire for character and intelligence, not just for CVs or experience. We look for people with drive and energy. People we trust. People who need to know their days are being well spent. That their work really matters. In the end, our success will be measured by the impact of our medicines. **To apply** Please submit your application through our website and refer to **Job ID 23359** in your cover letter. We receive a large volume of applications and are only able to contact those who are selected for an interview. All communication from our Talent Discovery team will come from an @abcellera.com email address.