Clinical Research Associate II – CNS/Psychiatry
Worldwide Clinical Trials
Senior Clinical Trial Manager, Ophthalmology
Aura Biosciences
full-time
Posted on:
Origin: • 🇺🇸 United States • Massachusetts
Visit company websiteSalary
💰 $140,000 - $185,000 per year
Job Level
Senior
About the role
- Provide clinical trial management for ongoing and future clinical trials in ocular melanoma
- Function as the Clinical Trial Lead on at least one trial managed in-house or with a CRO
- Partner with cross-functional stakeholders (Clinical, Regulatory, Product Development)
- Manage, execute and drive various aspects of clinical trial conduct with cross-functional team and contracted vendors
- Manage and drive CRO activities and deliverables if a CRO is utilized
- 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 informed consent templates, study plans and manuals, newsletters and site communications
- Collaborate with Data Management Vendor to develop eCRF and completion guidelines and conduct user acceptance testing
- Oversee data entry timelines, query management, metric reporting, and periodic clinical review of eCRF data
- Provide oversight and management of regional CRAs including review of site visit reports and training records
- Oversee site and CRA adherence to SOPs, Good Clinical Practice and FDA regulations
- Manage the Trial Master File (TMF) and ensure audit readiness
- Manage study budget and finances within established tolerances
- Facilitate and manage productive team communication and collaboration, both internally and externally
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
- 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
- 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
- Domestic travel required (10%-20%)
