Clinical Study Start Up Manager

Job description

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. **How you might spend your days** - 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 **We'd love to hear from you if** - 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 have direct, hands-on experience managing clinical study start-up and site activation activities (strongly preferred) - 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, 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 is 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 23385** 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.