Senior Clinical Trial Manager (Contract)

Job Description The Senior Clinical Trial Manager (Contract role) will be responsible for overseeing all operational phases of clinical research, from start‑up to database lock, ensuring studies are completed on time, within budget and in compliance with ICH‑GCP guidelines and regulations. Responsibilities Lead all clinical site interactions, including assistance with IRB/EC applications, contract negotiations, enrollment tracking, clinical trial material and supply requests, and issue resolution. Own and manage all trial start‑up, conduct, and close‑out activities according to industry and corporate standards. Lend expertise to the preparation of key clinical documents (protocols, informed consent, amendments, CRFs, training materials, project plans, monitoring plans, data plans, statistical analysis plans, summary reports, annual reports). Establish professional rapport and engage in frequent communication with investigational site personnel to keep the study on‑track. Track internal metrics, timelines and budgets. Communicate trial status to the trial team and prepare and present trial‑specific updates to management. Oversee and participate in monitoring activities at clinical trial sites to ensure adherence to GCP, ICH guidelines, regulatory requirements, SOPs, and protocols, and take ownership for data completion and accuracy. Interact with data management personnel to plan, monitor, and execute data analyses. Support applications and technical files as needed. Collaborate with project‑specific committees (e.g., DSMB, CEC) and 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 or required. Minimum Qualifications 8–10 years of experience in medical device (strongly preferred), pharmaceutical drug development, biotech or CRO industries monitoring and managing clinical trials (cardiovascular therapeutic indications preferred); or equivalent combination of education and experience. Proven expertise in executing IRB/EC submissions and approvals. Outstanding track record leading large, complex global clinical trials for medical device products in different phases of the product cycle. Broad and deep knowledge of device clinical trial documentation requirements, including monitoring requirements, FDA regulations, and operational aspects of clinical trials. Experience complying with GCP, ICH, ISO, and FDA regulatory requirements. Preferred Qualifications Master’s degree in Science, Life Sciences or relevant field; or equivalent combination of education and experience. Proven ability to identify operational issues and proactively recommend and implement strategies to resolve problems. In‑depth knowledge of adverse event investigation, analysis, and reporting procedures and standards. Willingness to be held accountable for deliverables. Highly organized, detail‑oriented and results‑driven. Strong initiative, positive attitude, and ability to build collaborative relationships both internally and externally. Demonstrated ability to make timely decisions using sound judgment. Experience interfacing with multiple vendors/contractors. Proven ability to handle multiple projects and changing priorities. Clear and concise verbal and written communication skills. Experience with electronic data capture (EDC). Experience in clinical budget planning and management. BA/BS in Science, Life Sciences or relevant field. Physical Attributes This is a standard office position. Equal Opportunity Employer TransMedics 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. #J-18808-Ljbffr