Clinical Trial Manager

Clinical Trial ManagerThis 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 supportManage 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-trackTrack internal metrics, timelines and budgetsCommunicate trial status to trial cross functional teamPrepare and present trial specific metrics and updates to Director, Program Managers and Senior ManagementParticipate 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 accurateIn conjunction with data management personnel, gain understanding of planning, monitoring, and executing data analysesSupport applications and technical files as neededCollaborate with project specific committees (e.g., DSMB, CEC)Assist with preparation for investigators' meetingsWork with vendors as neededTravel up to 25% of the timePerform other TransMedics tasks and duties as assigned/required.Management Responsibilities This position will not have management responsibilities.Minimum Qualifications7+ 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 experienceExperience interacting with sites, monitors, IRB's, sponsors, vendors, clinical centers, and FDAExperience screening and recruiting patients for studiesKnowledge of adverse event investigation, analysis and reporting procedures and standardsProficiency with electronic data management systemsFamiliarity with clinical budget planning and managementCoordinating external and internal documentation for clinical trialsUnderstanding of data collection methodologiesFamiliarity with GCP, ICH, ISO and FDA regulatory requirementsExperience in coordinating multi-center global clinical trialsAbility to build collaborative relationships both internally and externallyWilling to be held accountable for deliverablesMust be highly organized and detail orientedProven ability to handle multiple projects and changing prioritiesMust be results-driven and exhibit a sense of urgencyClear and concise in verbal and written communication, fosters smooth flow of timely and relevant informationStrong initiative and positive attitudeTransMedics is committed to equitable and transparent compensation. The expected base salary range for this role is $112,400.00 $140,200.00, which represents the company's current good-faith estimate of compensation for this position. Actual salary will depend on factors such as, but not limited to, candidate experience, qualifications, skills, and the specific work location. This role may also be eligible for bonuses, equity, and a comprehensive benefits package (medical, dental, vision, retirement savings, paid time off, and wellness resources). We comply with all U.S. pay transparency laws and do not request or consider salary history.Employee Benefit: Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MADentalVision Healthcare Flexible Spending AccountDependent Care Flexible Spending AccountShort Term DisabilityLong Term Disability401K PlanPet insurance Employee Stock Purchase PlanTransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.