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The role of the Clinical Study Manager (CSM) is focused on designing, planning, implementing, and managing the overall conduct, or particular elements, of clinical research projects. The goal of the CSM is to ensure compliance with the protocol and overall clinical objectives, as well as applicable SOPS and regulations.
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.
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 liaison to work with clinical sites, Contract Research Organizations (CROs), and other vendors.
Oversee activities of site monitors, including review and approval of visit reports.
Support budget forecasting.
Manage non-compliance for resolution and prevention.
Maintain familiarity with all applicable regulatory requirements and relevant clinical literature.
Participate in process improvement efforts.
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.
Additional responsibilities as required within the scope of position.
Bachelor’s degree in science / health-related field or a minimum of five years clinical research experience
Basic computer literacy (e.g., Windows, Word, Excel, PowerPoint)
Organizational skills, flexibility, and ability to multi-task