Sr. CTM (Clinical Trial Manager)

A variety of soft skills and experience may be required for the following role Please ensure you check the overview below carefully.

About Aura :

Aura Biosciences is a clinical stage oncology company. We are developing a novel technology platform based on virus-like drug conjugates (VDCs) to target and destroy cancer cells selectively, while activating the immune system to create long lasting anti-tumor immunity.

We have a goal of developing this technology in multiple cancer indications, focusing initially on two therapeutic areas ocular oncology and bladder cancer with a goal to expand into other areas of solid tumor oncology.

Initially we have focused our clinical development in the medical field of ocular oncology, a group of rare diseases that have no drugs approved.

We are in Phase 3 with our lead VDC AU-011 in choroidal melanoma. We are also in development in non-muscle invasive and muscle invasive bladder cancer, currently in a Phase 1 trial.

We have commenced a global Phase 3 program investigating the delivery of AU-011 for the treatment of small choroidal melanoma and indeterminate lesions.

AU-011 has to date demonstrated an excellent efficacy and safety profile in Phase 2 for choroidal melanoma, and enrolment is ongoing in the pivotal Phase 3 trial.

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.

• Sr. 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.

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.

Salary & Benefit Information :

Salary Range : $140,000 / yr - $170,000 / 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.

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