handle escalations for site management questions and issues for assigned projects
develop and deliver presentations & training to clients, colleagues and professionals, as required
conduct review of CRA visit reports within required timeframe, track CRA compliance and proactively escalate quality or non-compliance issues to Monitoring Management
Requirements
ophthalmic experience strongly preferred
prior team and/or site lead experience
understand how to properly assess an investigative site's capabilities for conducting clinical research
strong attention to detail in order to review CRA visit reports
extensive experience in the conduct of site evaluation, initiation, interim, and close-out visits
advanced Knowledge of the federal regulations governing research and the standards defining Good Clinical Practices
multilingual communication is a plus
bachelor's degree with 5 years' experience as a Clinical Research Associate or equivalent combination of education, training and experience. Years of experience may be considered in lieu of education
at Ora, we are building the future of ophthalmic clinical research
over the past forty years, our expert teams have helped earn more than fifty new product approvals
today, our team continues to expand across the globe, with over 350 employees across the US, Europe, Australia, and Asia
POSITION TITLE: Clinical Quality Assurance Manager, Ora Europe
DEPARTMENT: Clinical Quality Assurance
as the world's leading full-service ophthalmic drug and device development firm, we guide our clients across all phases of clinical research to efficiently bring new products and therapies to market
Requirements
bachelor's Degree
experience administrating within an electronic Quality Management System
proficient at organizing complex technical information, highly analytical and data-driven
proven data management skill, including routine use of tools , to organize information and perform metrics evaluation
knowledge and experience developing Policies, Standard Operating Procedures , Work Instructions and technical documents
demonstrated excellence in interpersonal communication, project management, and constructive problem-solving
attention to detail and excellent written communication skills