Clinical Project Manager
Current-Develop and maintain a working knowledge of FDA and other regulatory requirements that impact global clinical studies including ISO 14155, ICH GCP, and JGCP;-Responsible for achieving study objectives by working with team members to set priorities and milestones, while resolving project conflicts;-Primarily focused on the EUMDR Regulations and supporting submission to necessary regulatory bodies in a timely manner to ensure device is not pulled from the market-Understand and accept customer requests with an "I can help you" attitude;Coordinate, develop and/or review all essential clinical study-related documents;-Establish and maintain close working relationships with clinical site personnel, electronic data capture (EDC) vendors and other clinical vendors, and client stakeholders through exceptional communication on a regular basis;-Responsible for database management and statistical analyses;-Track study metrics (progress) in order to lead investigative site and study team resources toward achievement of milestones;-Lead meetings with investigative sites, physicians, and vendors as needed to ensure the success of the clinical study;-Train the study team, including investigators, site research staff, and vendors on study requirements;-Lead study team meetings with both internal and external stakeholders;-Respond promptly and appropriately to study issues raised by investigative sites, monitors, and vendors;-Work closely with others to ensure that appropriate resources are available for the project's success and that they are appropriately informed in a timely manner to offer guidance in resolving issues;-Participate in the statistical analysis, summarization, and reporting of clinical data for regulatory or marketing purpose throughout the course of the study; -Travel as needed- (once restrictions are lifted)
