POSITION SUMMARY
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.
RESPONSIBILITIES
This position is responsible for, but not limited to, the following:
- 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, CRF9s, 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 investigators9 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 preferred
- BA/BS in Science, Life Sciences or relevant field; or equivalent combination of education and experience
- Experience interacting with sites, monitors, IRB9s, 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
As part of our long-term growth plans, TransMedics is excited to announce our plan to relocate our headquarters (HQ) to Somerville, MA by 2028. We chose this location because we believe it is a place where innovation will thrive. Our new state-of-the-art headquarters is designed to support collaboration, creativity, and discovery. We believe this will be a place where we can continue to do things few thought possible in organ transplantation to help patients.Specific timing and role impact may vary.
Maximize your potential at TransMedics, Inc.
TransMedics is committed to equitable and transparent compensation. The expected base salary range for this role is$112,400.00 6 $140,200.00, which represents the company9s 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.
