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AbCellera Verified
Biotechnology, Pharmaceutical, Artificial Intelligence, Drug Discovery

Clinical Systems Analyst

Montreal, QCOnsiteFull TimePosted 16 days ago

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Required skills

  • Clinical Systems Analyst
  • Business Operations
  • clinical trial system implementations
  • test scripts
  • user support
  • Clinical Operations
  • Digital Quality
  • IT
  • GxP
  • ICH-GCP

Nice to have

  • Life Sciences
  • pharmaceutical
  • biotech
  • CRO
  • bilingualism
  • English

Role summary

AbCellera is seeking a motivated Clinical Systems Analyst to join their Business Operations team. This role will provide hands-on support for clinical trial system implementations and sustainment, including design sessions, test script execution, and user support. The analyst will act as a liaison between Clinical Operations, Digital Quality, and IT, offering user training, troubleshooting, and coordinating with vendors. Responsibilities include creating validation test scripts, managing system changes, and analyzing issues to determine action plans. A Bachelor's degree in a Life Sciences field with 5+ years of experience in pharma, biotech, or CRO is preferred, along with knowledge of GxP, ICH-GCP, and Canadian regulations.

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 who need them. We pursue truth and scientific rigour and have the courage to work at the edge of the unknown.

We are looking for a motivated Clinical Systems Analyst to join our Business Operations team. You’ll provide hands-on support for our clinical trial system implementations and sustainment. This will include participating in design sessions, executing test scripts, and supporting users. As AbCellera's clinical pipeline grows, you'll build your expertise across these systems while becoming an invaluable liaison between Clinical Operations, Digital Quality, and IT.

How you might spend your days

  • Providing day-to-day user training, support, and troubleshooting issues for clinical systems users
  • Creating and executing validation test scripts to confirm system changes meet GxP and business requirements
  • Coordinating and collaborating with vendors on configuration changes, upgrades, and routine issues
  • Supporting change and release activities tied to protocol amendments and vendor system releases
  • Identifying and analyzing issues and trends related to systems and determining action plans (training, configuration changes, etc.)
  • Working with stakeholders to understand roadblocks and translate those into actionable configuration changes and system improvements

    • We’d love to hear from you if

  • You have a Bachelor’s degree (BSc) in a Life Sciences related field, combined with 5+ years of experience, preferably within a pharmaceutical, biotech, or CRO environment
  • You have a working knowledge of ICH-GCP guidelines and Health Canada regulations, and you are familiar with the Canadian clinical trial regulatory landscape (a significant asset)
  • You have experience with clinical trial systems (RTSM, EDC, eCOA, or similar)
  • You have solid documentation habits and a keen attention to detail
  • You are highly organized with a proactive, problem-solving mindset, and the ability to manage multiple competing priorities effectively
  • You have exceptional written and verbal communication skills, with bilingualism (English and French) being highly preferred for this role

    • 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, professional development opportunities, and comprehensive health benefits. Scientific and technical mentorship are 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 23420 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.

    Ready to apply?
    You'll be redirected to AbCellera's application page.

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