Job Description:Clinical Study Manager ( )Job:Clinical/RegulatoryPrimary LocationOther LocationsTravel:40Shift:DaySchedule:Full:timeClinical Study Manager: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/industriesAbout 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 management of 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 liaisonto 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 positionRequired Qualifications:Bachelors degree in science / health:related field or a minimum of five years clinical research experience:Experience working on cross:functional teams:Basic computer literacy (e.g., Windows, Word, Excel, PowerPoint):Organizational skills, flexibility, and ability to multi:task:Strong verbal and written communication skills:Ability to travel up to 40Desired Qualifications:Experience in clinical / scientific research, nursing, or medical devices / pharmaceutical industry preferredWhat We Offer:At Gore, we want our Associates to have fulfilling careers driven by curiosity and commitment. In return, we commit to our Associates by offering comprehensive, competitive rewards in the form of compensation, benefits, an Associate stock ownership:type plan, and opportunities for growth and development. Learn more at gore/careersWe believe in the strength of a diverse workforce and inclusive work environment. In support of our values and continued success we are proud of Associates around the world who support an inclusive work environment, strive to reflect the diversity of the communities where we operate, and ensure all Associates and external partners are treated with fairness, dignity and respect.
