Sr. Clinical Trial Manager (Ophthalmology)

About Aura:

Aura Biosciences is a clinical-stage biotechnology company focused on developing precision therapies for solid tumors that aim to preserve organ function. Our lead candidate, bel-sar (AU-011), is currently in late-stage development for primary choroidal melanoma and in early-stage development in other ocular oncology indications and bladder cancer. Aura Biosciences is headquartered in Boston, MA. Our mission is to grow as an innovative global oncology company that positively transforms the lives of patients.

For more information, visit aurabiosciences.com. Follow us on X (formerly Twitter) @AuraBiosciences and visit us on LinkedIn.

Roles & Responsibilities:

This position will provide clinical trial management for ongoing and future clinical trials in our lead programs in ocular melanoma. Candidate will function as the Clinical Trial Lead on at least one trial that is managed either in-house by the Aura Clinical Team or in collaboration with a Contract Research Organization (CRO). 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.

Essential functions:

• Clinical Trial Manager will be responsible for managing, executing and driving various aspects of clinical trial conduct with a cross-functional team of subject matter experts including Clinical Development, Device, Clinical Supply, Data Management, Biometrics, contracted Vendors, and Regulatory to achieve clinical trial goals on time and within budget. If the study is utilizing a CRO, this will be inclusive of managing and driving their activities and deliverables.
• Develop and implement clinical processes and procedures including site budgets and contracts, investigator payments, protocol compliance reporting, risk assessments and investigational product and device management.
• Develop and maintain clinical trial documents including but not limited to informed consent templates, study plans and manuals, newsletters and site communications.
• Collaborate with Data Management Vendor to develop eCRF and completion guidelines as well as conduct user acceptance testing prior to release.
• Oversee data entry timelines and query management, including metric reporting.
• Oversee and conduct periodic clinical review of data entered into eCRF.
• Provide oversight and management of regional Clinical Research Associates (CRAs) including review of site visit reports and training records.
• Oversee investigative site and CRA adherence to SOPs, Good Clinical Practice and FDA regulations.
• Manage the Trial Master File (TMF) and ensure contents are current and audit ready.
• Manage study budget and finances within established tolerances.
• Facilitate and manage productive team communication and collaboration, both internally and externally.

Qualifications:

• 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.
• Global clinical trial management strongly 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.
• Domestic travel required (10%-20%)

Salary & Benefit Information:

Salary Range: $140,000/yr - $185,000/yr

(Placement within the listed range depends on many factors including, but not limited to: geographic location, degree, years of experience, and internal company equity)

Health insurance with FULL premium coverage

401K with company match

Employee Stock Purchase Program (ESPP)

Competitive paid time off (PTO)

Company-paid short & long-term disability insurance and life insurance