At Aura Biosciences, we are developing a new class of therapies based on an expressed virus-like particle bioconjugate to target and destroy cancer cells selectively, while leaving surrounding tissue unharmed. By safely eliminating cancer locally, we can treat early and transform the lives of people with a wide range of cancers that are poorly managed today.
Our lead program in ocular melanoma is designed to remove cancer cells in the back of the eye as a first-line therapy potentially long before the disease progresses and metastasizes. Come help develop a first-in-class treatment to selectively destroy cancer cells!
Roles & Responsibilities:
This position will provide clinical trial management support for ongoing and future clinical trials in our lead program in ocular melanoma. Candidate will function as the Clinical Trial Lead on at least one trial that is managed in-house by the Aura Clinical Team. Partnering closely with the cross-functional stakeholders (Clinical, Regulatory, Product Development), you will apply strong clinical and project management fundamentals for the implementation of various aspects of our clinical trials.
Reporting to the Sr. Director, Clinical Operations, the Clinical Trial Manager will be responsible for managing various aspects of clinical trial conduct with subject matter experts including clinical development, contract vendors, and regulatory to achieve clinical trial goals on time and within budget.
Develop clinical trial documents including informed consent templates, source documents, and Study Procedure Manual contents.
Collaborate with Data Management Vendor to develop eCRF and completion guidelines as well as conduct user acceptance testing prior to release.
Develop and implement clinical processes and procedures including site budgets, investigator payments, protocol compliance reporting, and investigational product management.
Provide oversight and management of regional Clinical Research Associates (CRAs) including review of site visit reports and training records.
Oversee data entry timelines and query management, including metric reporting.
Conduct periodic clinical review of data entered into eCRF.
Oversee investigative site and CRA adherence to SOPs, Good Clinical Practice and FDA regulations.
Manage the Trial Master File (TMF) and ensure contents current.
Facilitate and manage productive team communication and collaboration, both internally and externally.
The ideal candidate should have a minimum of a bachelor’s degree in the life sciences and 5-8 years of direct and progressive experience specific to biopharma clinical trial management with a track record of successful management of complex programs using multiple external vendors. Experience in ophthalmology and/or oncology preferred.
Candidates should have experience with Microsoft office programs and web-based data entry platforms.
Candidates should have a passion for learning, creating, relating, communicating, and helping drive the success of cross functional teams.
Based in the Company’s North Cambridge office, with travel as required to support Site Qualification and Site Initiation Visits. Remote-based candidates may be considered.
Email a cover letter and a copy of your CV to HR@aurabiosciences.com referencing the position description in the subject line.