Global Clinical Study Manager

• 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

• 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
• strong working knowledge of Good Clinical Practice (GCP), regulatory requirements, and clinical trial management
• previous experience as a CRA, or experience working at clinical sites
• strong organizational and project management skills, with the ability to prioritize and manage competing deadlines
• bilingual with excellent communication skills, both written and verbal, and have the ability to collaborate effectively with internal teams, external vendors, and clinical investigators
• proficient in clinical trial management systems (CTMS), electronic data capture (EDC) systems, and other relevant software

certified in Clinical Research, such as ACRP, SOCRA (desirable)

• equity
• annual bonus dependent on team and company performance
• a 6% (non-match) RRSP contribution
• CAD $1,500 annual Active Lifestyle Allowance
• annual vacation
• opportunity for flexible work arrangements
• professional development opportunities
• comprehensive health benefits
• scientific and technical mentorship