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Arbor Biotechnologies is a next-generation gene editing company advancing a pipeline of novel gene editing therapeutics for genetic conditions, from ultra-rare to common diseases. The company's optimized gene editors unlock access to new gene targets, with a robust pipeline of first-in-class assets focused on diseases of high unmet need. The lead program, ABO-101, is progressing into clinical trials for primary hyperoxaluria type 1, with research and development focused on genomic diseases of the liver and CNS.
The Senior Clinical Trial Manager will be at the forefront of early-phase studies, reporting to the Senior Director of Clinical Operations. This is a highly visible role for a novel class of gene editing therapeutics in rare genetic diseases. The role is a key contributor to implementing and executing clinical trials from start-up to close-out, with accountability for clinical trial management, trial master file, site monitoring, study start-up activities, and CRO management.
Responsibilities include overall management of clinical study sites and external vendors while adhering to budget, scope, and schedule requirements in accordance with GCP and ICH guidelines. The role will develop and effectively manage budgets and timelines for assigned clinical studies, participate in the development of clinical operations study plans, study templates, and SOP/WI documentation. The manager will participate in creation and review of study protocols, Informed Consent Forms (ICFs), Case Report Forms (CRFs), Statistical Analysis Plans (SAPs), Clinical Study Reports (CSRs), and other clinical documents to ensure seamless integration between clinical objectives and study performance.
Additional responsibilities include assisting in management of cross-functional study teams and establishing/maintaining key internal and external stakeholder relationships to ensure study milestones are met, as well as tracking and overseeing lab sample transfers from patients to sites to clinical lab vendors. The ideal candidate is driven by purpose and fueled by curiosity, takes ownership, thinks boldly, and stays resilient through challenge. They lead with humility, value diverse perspectives, and put the success of the team above personal recognition.
