Senior Clinical Trial Manager

2 days ago

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Aura Biosciences

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research • development • biotechnology • nanotechnology • drug development

51 - 200

Description

• Provide clinical trial management support for ongoing and future clinical trials in ocular melanoma • Function as the Clinical Trial Lead on at least one trial managed in-house • Partner closely with cross-functional stakeholders to implement various aspects of clinical trials • Manage various aspects of clinical trial conduct with subject matter experts • Develop clinical trial documents including informed consent templates and source documents • Collaborate with Data Management Vendor to develop eCRF and conduct user acceptance testing • Develop and implement clinical processes and procedures including site budgets and protocol compliance reporting • Provide oversight and management of regional Clinical Research Associates (CRAs) • 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 are current • Facilitate and manage productive team communication and collaboration

Requirements

• Minimum of a bachelor's degree in the life sciences • 5-8 years of direct and progressive experience specific to biopharma clinical trial management • Experience in Ophthalmology and/or Oncology preferred • Global clinical trial management strongly preferred • Experience with Microsoft office programs and web-based data entry platforms • Passion for learning, creating, relating, communicating, and helping drive the success of cross functional teams

Benefits

• 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