Global Clinical Study Manager

AbCellera•Montreal, QC

2d•Hybrid

About The Position

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.

Requirements

8+ years of demonstrated work experience in clinical study management
Bachelor’s degree in a related field
Strong working knowledge of Good Clinical Practice (GCP), regulatory requirements, and clinical trial management
Proficient in clinical trial management systems (CTMS), electronic data capture (EDC) systems, and other relevant software
Bilingual with excellent communication skills, both written and verbal
Ability to collaborate effectively with internal teams, external vendors, and clinical investigators
Strong organizational and project management skills, with the ability to prioritize and manage competing deadlines

Nice To Haves

Previous experience as a CRA, or experience working at clinical sites
Certified in Clinical Research, such as ACRP, SOCRA

Responsibilities

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