Senior Clinical Study Manager

AbCellera is breaking the barriers of conventional drug development to propel antibody-based medicines from target to clinic. We are a team of scientists, engineers, creatives, and business professionals who believe that advancing science enhances lives. We have developed technologies to unlock high-value drug targets, including antibody-drug conjugates and T-cell engagers for cancer, and complex transmembrane proteins for indications such as metabolic and endocrine conditions, pain, and autoimmunity.

We are seeking a highly experienced and detail-oriented Senior Clinical Study Manager (CSM) to join our growing clinical operations team. As the Senior CSM you will plan, lead and oversee clinical trials from start-up through to completion, ensuring 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 clinical monitor and regulatory personnel, to deliver high-quality clinical data while maintaining adherence to the budget and timelines. You are a leader who is adaptable to fast-paced environments, possesses strong project management skills, and has a deep understanding of the clinical trial process.

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, Good Clinical Practice (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.
• Monitoring and ensuring the safety and welfare of study participants by adhering to safety reporting guidelines and promptly addressing any safety concerns.
• Providing guidance and mentorship to other team members, fostering growth and development within the team.

We'd love to hear from you if :

• You have a Bachelor’s or Master’s degree in a relevant field, and a minimum of 8 years of demonstrated work experience as a Clinical Project Manager or Clinical Study Manager.
• You have strong working knowledge of Good Clinical Practice (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.
• Early phase clinical trial experience across multiple therapeutic areas is a real asset.
• You have the ability to manage CROs, external vendors, and engage in contract negotiations.
• Organizational and project management skills are a real strength.
• You think strategically and collaborate effectively across teams.
• You are proficient in clinical trial management systems (CTMS), electronic data capture (EDC) systems, and other relevant software.

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 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 are focused on bringing innovative medicines to patients, both by advancing our internal pipeline of programs and partnering with companies that have novel science or innovative technology.

And it all starts with our team. We’ve built a place where people feel they are part of something bigger than themselves. A place that exists to push the limits of science and technology, and aims to bring better therapies to patients.

We look for people with drive and energy. Idealists. People we love and people we trust. This may be unconventional, but it is the key to our success.

To apply :

Please submit your application through our website and refer to Job ID 23290 in your cover letter. We apologize in advance, but we receive a large volume of applications and are only able to contact those who are selected for an interview.