Clinical Study Start Up Manager

AbCellera • Montreal, QC

2d

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 an experienced Clinical Study Start-Up Manager to join our growing Clinical Operations team. You will play a foundational role in the execution of all start-up activities for assigned clinical trials, working hands-on to ensure that clinical sites are selected, qualified, and activated efficiently. Your primary goal will be to accelerate study timelines by managing the collection of essential documents, preparing regulatory and ethics submissions, and facilitating the execution of site contracts, all while ensuring strict adherence to GCP and regulatory standards.

Requirements

• You possess deep, specialized knowledge of study start-up milestones, including local/global regulatory pathways, ethics submissions, and contract/budget frameworks
• You have a Bachelor’s degree (BSc) in Life Sciences, Nursing, or a related field, combined with 8+ years of clinical research experience, preferably within a pharmaceutical, biotech, or CRO environment
• You possess a strong working knowledge of ICH-GCP guidelines and Health Canada regulations, and you are highly familiar with the Canadian clinical trial regulatory landscape (a significant asset)
• You are highly organized with a keen attention to detail, bringing a proactive, problem-solving mindset, and the ability to manage multiple competing priorities effectively
• You have exceptional written and verbal communication skills

Nice To Haves

• You have direct, hands-on experience managing clinical study start-up and site activation activities (strongly preferred)
• bilingualism (English and French) being highly preferred for this role.

Responsibilities

• Overseeing the collection, rigorous review, and tracking of all essential site documents required for study activation, including Investigator CVs, medical licenses, financial disclosures, and FDA1572/QIU Forms
• Ensuring all start-up documentation is high-quality, filed correctly, and maintained in an inspection-ready state within the Trial Master File (TMF)
• Collaborating with the Regulatory team in preparing and reviewing comprehensive submission packages for Health Authorities, Research Ethics Boards (REBs), and/or Institutional Review Boards (IRBs) to support rapid trial clearance
• Adapting site-specific Informed Consent Forms (ICFs) and other patient-facing materials to align with local requirements, while maintaining regulatory and ethical standards
• Tracking regulatory submission and approval statuses globally, while promptly addressing and resolving queries from health authorities and ethics committees
• Supporting site identification, feasibility assessment, and qualification to ensure the selection of high-performing clinical research sites
• Serving as the primary Sponsor point of contact for clinical site staff, investigators, and external CRO start-up leads throughout the critical activation phase
• Facilitating and accelerating the negotiation of Clinical Trial Agreements (CTAs) and site budgets by partnering closely with legal, finance, and management teams to resolve bottlenecks
• Collaborating closely with Clinical Research Associates (CRAs), Clinical Project Managers (CPMs), and other internal stakeholders to provide start-up updates, mitigate risk, and transition sites seamlessly from activation to study conduct

Benefits

• equity
• annual bonus dependent on team and company performance
• a 6% (non-match) RRSP contribution
• a CAD $1,500 annual Active Lifestyle Allowance
• annual vacation
• professional development opportunities
• comprehensive health benefits
• Scientific and technical mentorship
• a strong sense of community and connections across AbCellera through our work, clubs, and socials

What This Job Offers

• Job Type: Full-time
• Career Level: Senior