Clinical Trial Manager

Job Description:POSITION SUMMARYThis Clinical Trial Manager role is responsible for leading the end-to-end execution of clinical trials, ensuring studies are delivered on time, within budget, and in compliance with regulatory and corporate standards. The position oversees trial start-up, conduct, and close-out activities, while serving as a key point of coordination across investigational sites, cross-functional teams, and external partners. This individual drives study progress through proactive communication, meticulous planning, and effective management of timelines, documentation, and trial metrics, contributing to the successful delivery of high-quality clinical data.RESPONSIBILITIES This position is responsible for, but not limited to, the following: Lead for the end-to-end clinical trial deliveryManage trial start-up, conduct, and close-out activities according to industry and corporate standards with Director support  Manage clinical site interactions (including assistance with IRB/EC applications, contract negotiations, enrollment tracking, clinical trial material and clinical supply requests, issue resolution, etc.)  Prepare key clinical documents (e.g. protocols, informed consent, amendments, CRF’s, training materials, project plans, monitoring plans, data plans, statistical analysis plans, summary reports, annual reports, etc.)  Establish professional rapport and engage in frequent communication with investigational site personnel in order to keep study on-track  Track internal metrics, timelines and budgets  Communicate trial status to trial cross functional team Prepare and present trial specific metrics and updates to Director, Program Managers and Senior Management  Participate in monitoring activities at clinical trial sites to assure adherence to GCP and ICH guidelines, regulatory requirements, SOPs, protocols and ensure that data is complete and accurate  In conjunction with data management personnel, gain understanding of planning, monitoring, and executing data analyses  Support applications and technical files as needed  Collaborate with project specific committees (e.g., DSMB, CEC)  Assist with preparation for investigators’ meetings  Work with vendors as needed  Travel up to 25% of the time  Perform other TransMedics tasks and duties as assigned/required.   MANAGEMENT RESPONSIBILITIES This position will not have management responsibilities.  MINIMUM QUALIFICATIONS  7+ years of CRA, CTA or equivalent, with medical device experience CTM experience preferredBA/BS in Science, Life Sciences or relevant field; or equivalent combination of education and experience Experience interacting with sites, monitors, IRB’s, sponsors, vendors, clinical centers, and FDA  Experience screening and recruiting patients for studies  Knowledge of adverse event investigation, analysis and reporting procedures and standards &nb...