Who are we? Arbor Biotechnologies, a clinical stage, next-generation gene editing company based in Cambridge, MA, is advancing a portfolio of first-in-class genomic medicines addressing serious diseases for which there are no existing functional cures, with a... Backed by Accel.
About the role
The Senior Clinical Trial Manager will be at the forefront of our early phase studies. The role will report into the Senior Director of Clinical Operations and will be in a highly visible role for a novel class of gene editing therapeutics in rare genetic diseases. The role will be a key contributor to implementing and executing clinical trials from start-up to close-out. The role will be accountable for clinical trial management, trial master file, site monitoring, study start-up activities, and CRO management.
What they're looking for
- Bachelor’s degree and 6+ years or relevant and progressive clinical operations experience working in the pharmaceutical and/or biotech industry, preferably a mix of both
- Experience managing early-phase clinical studies in rare diseases
- Solid well-grounded experience in setup, execution and operational management of US and global clinical trials (delivered on time, within budget, and with high quality)
- Experience in ethics and regulatory dossier submissions (e.g., pre-IND, IND, Scientific Advice, CTA)
- Strong knowledge of GCP/ICH, drug development process, and other relevant guidelines for clinical research activities
- Proven track record of experience working with CROs, functional service providers and third-party vendors, strong contract negotiation abilities and thorough understanding of all financial aspects of contracts
More about this role
The Senior Clinical Trial Manager will be at the forefront of our early phase studies. The role will report into the Senior Director of Clinical Operations and will be in a highly visible role for a novel class of gene editing therapeutics in rare genetic diseases. The role will be a key contributor to implementing and executing clinical trials from start-up to close-out. The role will be accountable for clinical trial management, trial master file, site monitoring, study start-up activities, and CRO management.
- Overall responsibility for the management of clinical study sites and external vendors while adhering to budget, scope and schedule requirements in accordance with GCP and ICH guidelines
- Develop and effectively manage budgets and timelines for assigned clinical studies
- Participate in the development clinical operations study plans, study templates and SOP/WI
- 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
- Assist in management...
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