Akouos is building a leading gene therapy company focused on hearing disorders. We are a precision genetic medicine company focused on developing gene therapies with the potential to restore, improve, and preserve high-acuity physiologic hearing for individuals who live with disabling hearing loss worldwide.
Restoring, improving, and preserving high-acuity hearing is an area of high unmet need in medicine: 466 million people worldwide have disabling hearing loss, and there are no FDA-approved pharmacologic therapies to address its underlying causes.
Akouos was founded in 2016 by leaders in the fields of neurotology, genetics, inner ear drug delivery, and AAV gene therapy. Listening is in our DNA. We believe the only way to achieve our ambitious goals is to engage as one team, listen to each other, and trust in ourselves and our science.
The Senior/Clinical Project Manager, Clinical Operations, is responsible for clinical study planning and execution and includes, but is not limited to, participation in the preparation of study related materials, management of CROs and other study vendors, identification of project risks and contingency planning, as well as management of the project budget, study timelines, and study deliverables.
- Manage clinical study activities from study start-up through database lock and clinical study report, ensuring adherence to protocol, ICH/GCP, and relevant SOPs
- Actively participate in the selection of vendors, including CROs
- Prepare and review documents related to the clinical study, including Informed Consent Form(s), study plans, and site budget templates; participate in Case Report Form design and user acceptance testing
- Manage studies within agreed timelines and budget, and coordinates cross functional efforts to achieve study objectives and goals
- Establish and maintain effective relationships with investigator sites and study vendors
- Provide operational oversight of the CRO and study vendors as the primary point of contact; monitor progress and quality metrics, identify risks and issues, and implement appropriate mitigation activities and/or contingency plans
- Review monitoring reports, protocol deviations, and data listings to ensure reliable quality data are delivered; performs oversight monitoring visits as needed
- Provide oversight of the clinical trial master file to ensure compliance with quality standards and maintain inspection readiness
- Effectively communicate with the study sites
- Bachelor’s Degree is required; degree in health or biologic science is preferred
- 5+ years of clinical research experience with 3+ years as a clinical project manager; experience in rare diseases and/or difficult to recruit patient populations is preferred
- Strong project management and risk management skills, including management of study vendors
- Excellent listening and communication skills, as well as organizational skills
- Strong knowledge of ICH Good Clinical Practice principles
- Site monitoring experience is preferred
- Ability to travel up to 20% of the time