Clinical Trial Manager

Job Description:

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, 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 preferred
• 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

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.

Every Organ Wasted is a Life Not Saved.

TransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. Our mission is to help save more patients' lives by increasing access to viable donor organs for those who are awaiting an organ transplant. To accomplish this mission, we partner closely with transplant stakeholders worldwide and help expand their access to healthy donor organs, while delivering the highest quality technology, service, clinical care and outcomes.


Driven by a passion for improving patient care, we make the impossible possible and keep our employees at the center of everything we do. Together, we strive to enhance the quality of life for transplant recipients and their families, fostering hope and healing in the journey toward better health.


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 - $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 MA

Dental

Vision


Healthcare Flexible Spending Account

Dependent Care Flexible Spending Account

Short Term Disability

Long Term Disability

401K Plan

Pet insurance


Employee Stock Purchase Plan

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.