Clinical Trial Manager II

TransMedics, Inc.•Andover, MA

1d•Remote

About The Position

This 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.

Requirements

7+ years of CRA, CTA or equivalent, with medical device experience
BA/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
Proficiency with electronic data management systems
Familiarity with clinical budget planning and management
Coordinating external and internal documentation for clinical trials
Understanding of data collection methodologies
Familiarity with GCP, ICH, ISO and FDA regulatory requirements
Experience in coordinating multi-center global clinical trials
Ability to build collaborative relationships both internally and externally
Willing to be held accountable for deliverables
Must be highly organized and detail oriented
Proven ability to handle multiple projects and changing priorities
Must be results-driven and exhibit a sense of urgency
Clear and concise in verbal and written communication, fosters smooth flow of timely and relevant information
Strong initiative and positive attitude

Nice To Haves

CTM experience preferred

Responsibilities

Lead for the end-to-end clinical trial delivery
Manage 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.