What are the responsibilities and job description for the Clinical Trial Manager position at Arbor Biotechnologies?
Who are we?Arbor Biotechnologies™, a next-generation gene editing company based in Cambridge, MA, is advancing a pipeline of novel gene editing therapeutics to address a wide range of genetic conditions - from the ultra-rare to the most common genetic diseases. The company's unique suite of optimized gene editors goes beyond the limitations of early editing technologies to unlock access to new gene targets and has fueled a robust pipeline of first-in-class assets focused on diseases of high unmet need. With Arbor's lead program, ABO-101 for the treatment of primary hyperoxaluria type 1, progressing into clinical trials, the company continues to focus their research and development efforts on genomic diseases of the liver and CNS for which there are no existing functional cures. For more information, please visit : arbor.bio.Who are you?Passionate, determined, and accountable. Curious, resourceful, innovative, forward thinking, and resilient. Authentic, humble, open-minded and puts team above self. At Arbor, our people embrace these qualities, so if this sounds like you then please read on!About the Role : The Clinical Trial Manager will be at the forefront of our early phase studies. The role will report into the Director of Clinical Operations and will be in a highly visible role for a novel class of gene editing therapeutics in Rare 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 You Can Expect : Management of clinical study sites and external vendors while adhering to budget, scope and schedule requirements in accordance with GCP and ICH guidelinesParticipate in the development of clinical operations study plans, study templates and SOP / WIParticipate 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 performanceEffectively communicate with cross functional study teams and establish / maintain key internal and external stakeholder relationships to ensure study milestones are metTrack and oversee lab sample transfers from patients to sites to clinical lab vendorsProactively identify and resolve issues and manage escalation as appropriateManage timelines for Safety Review Boards, Data Monitoring Committee and Data CutsOversee maintenance of trial documentation and master file, data validation, and completion guidelinesParticipate in vendor review, selection, and negotiationsAssist with the planning and execution of investigator Meetings as required.Represent the company externally and travel to investigative sites as neededWhat You Bring : NOTE : this is not a remote position and on-site presence is required in our Cambridge office (typically 2-3 days per week)Bachelor's degree and 4 years or relevant and progressive clinical operations experience working in the pharmaceutical and / or biotech industry, preferably a mix of bothExperience managing early-phase clinical studiesRare disease and gene editing study management is a plusExperience in setup and execution of US and global clinical trials (delivered on time, within budget, and with high quality)Knowledge of GCP / ICH, drug development process, and other relevant guidelines for clinical research activitiesProven track record of experience working with CROs, functional service providers and third-party vendorsScientifically adept with knowledge of mRNA, RNAi, LNP, AAV or gene therapy drug development Ability to work independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team membersExcellent planning, organization, and time management skills Effective communication and interpersonal skills Motivated to roll up your sleeves and apply drug development knowledge and experience to develop gene-editing therapies in a startup environmentFlexibility to travel domestically and internationally as requiredOur Values : Our values govern the work we do at Arbor, and we're hoping that they resonate as strongly with you as they do with us!
- Purposeful Action : Start with The Why
- Bold Resilience : Adopt a Growth Mindset
- Humble Authenticity : Start in the HeartWe promote diversity and inclusion not just in our recruitment processes, but in everything we do. We're an equal opportunity employer and we will continue to ensure our recruitment process is free of bias and our workplace is inclusive, positive, and free of discrimination and respecting of all backgrounds and beliefs.
