About Us:Gore is a materials science company focused on improving lives through discovery, product innovation and rewarding careers for our Associates. About the Industry:Saving lives and improving the quality of life for patients is at the core of everything we do. This meaningful work gives purpose to our lives and inspires us to create solutions that make a difference in the lives of others. Learn more at gore/products/industries About the Role:We are looking for a Clinical Study Manager to join our Clinical Team in Beijing first preferred, then is shanghai, China who will be responsible for daily clinical activities. Responsibilities:Coordinate the activities of interdisciplinary Gore team members in the planning, executing, and closing of clinical studies; Develop and approve study:specific documents, tools, presentations, and processes. Deliver study:related training and select and coordinate DSMB / CEC / Steering Committees, when applicable Prepare and present at Investigator meetings. Participate in the site qualification, study initiation, and study closure process Assist with the managementof medical device distribution, receipt, use, and return Routinely review data / CRFs to ensure data integrity, accuracy, and protocol compliance. Track and report progress of studies to applicable internal stakeholders, including patient screening, enrollment, data collection, adverse event documentation, and reporting Develop Study Reports and provide clinical portions for Regulatory submissions. Assist in query writing and resolution process. Identify and gather missing or incomplete data from investigational sites Conduct site visits, as necessary Act as a company liaison to work with clinical sites, Contract Research Organizations CROs, and other vendors. Support budget forecasting and Approve payments Oversee activities of site monitors, including review and approval of visit reports. Manage non:compliance for resolution and prevention Maintain familiarity with all applicable regulatory requirements and relevant clinical literature. Maintain knowledge of industry and regulatory trends as required to meet business needs and perform the responsibilities of the position. Maintain compliance with training expectations as required for this position Participate in process improvement efforts. And additional responsibilities as required within the scope of position
