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Form of workAbout Aura:At Aura, our mission is to develop a new class of oncology targeted therapies that deliver meaningful therapeutic benefit to a range of cancer indications with high unmet need in which we believe we can establish a new standard of care. We are driven by our passion and commitment to science and the patients battling cancer who are relying on us to pioneer these new therapies.We are focusing the initial development of our VDC technology platform to treat tumors of high unmet need in ocular and urologic oncology. AU-011, our first VDC candidate, is being developed for the first line treatment of primary choroidal melanoma, a rare disease with no drugs approved.
Beyond primary choroidal melanoma, we are developing AU-011 in additional ocular oncology indications, including choroidal metastases. Leveraging our VDCs' broad tumor targeting capabilities, we also plan to initiate a clinical program in non-muscle invasive bladder cancer, or NMIBC, our first non-ophthalmic solid tumor indication.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.Essential functions:* 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.
