New · posted Nov 1
TransMedics · Medical Devices
Principal Clinical Trial Manager
- Andover, MA
- On-site
- Full-time
- Manager
The role
The Principal Clinical Trial Manager provide leadership in the development of clinical trial activities and ensure that clinical trials are completed in time and with the highest quality with thoughtful delegation of study related tasks and assignments.
What you need
MINIMUM QUALIFICATIONS
- BA/BS in Science, Life Sciences or relevant field
- 8-10 years’ pharmaceutical drug development, biotech or CRO industries experience 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
PREFERRED QUALIFICATIONSnice to have
- Masters in Science, Life Sciences or relevant field; or equivalent combination of education and experience
- Experience in medical device (strongly preferred),
- 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
- 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
- Willing to be held accountable for deliverables
- Must be highly organized and detail oriented
- Experience interfacing with multiple vendors/contractors
- 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
- Ability to support and build collaborative relationships both internally and externally
- Demonstrated ability to make timely decisions using sound judgment
- Experience with electronic data capture (EDC)
- Experience in clinical budget planning and management
- Influential & assertive communication skills
- Excellent leadership skills
- Good record keeping skills
- Ability to motivate
- Self Confidence
- Ability to think Out-of-the-box
- Problem solving skills
- Conflict management skills
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.
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.
www.TransMedics.com
TransMedics is committed to equitable and transparent compensation. The expected base salary range for this role is $151,500.00– $215,700.00, 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.
What you'll do
This position is responsible for, but not limited to, the following:
- Leading the process of pre and post market clinical trials for FDA by employing effective organizational strategies and reviewing and presenting the results using rigorous clinical procedures
- Responsible for creating study specific templates across all programs
- Responsible for managing the planning, implementation, and tracking of the clinical monitoring process with CRAs
- Provide oversight of drafting all annual and bi-annual pre and post market reports to FDA in collaboration with the regulatory team
- Lead all clinical site interactions (including assistance with IRB/EC applications, contract negotiations, enrollment tracking, clinical trial material and clinical supply requests, issue resolution, etc.)
- 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 in conjunction with other team members (e.g. protocols, informed consent, amendments, CRF’s, training materials, project plans, monitoring plans, data plans, statistical analysis plans, summary 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 team
- Prepare and present trial specific updates to management
- Oversee and participate in monitoring activities at clinical trial sites to ensure adherence to GCP and ICH guidelines, regulatory requirements, SOPs, 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)
- Assist with preparation for investigators’ meetings
- Work with vendors as needed
- Perform other TransMedics tasks and duties as assigned/required.
MANAGEMENT RESPONSIBILITIES
This position manages the following positions on a daily basis.
- This position will not have management responsibilities.
PHYSICAL ATTRIBUTES
- None (Standard office environment).
- Travel up to 25% of the time
Pay
$151,500 – $215,700 a year
Employer providedMedical 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
Where you'll work
Andover, MAOn-siteOpen in Maps (opens in a new tab)
More jobs in Andover, MAEqual opportunity, accessibility and legal noticesTransMedics's statements, word for word
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.
Job intelligence
The context around this role
Live data · November 1, 2026
Salary intelligence
How the pay compares
This role's midpoint is 13% above the US median for Clinical Trial Management roles at this level.
This roleEmployer provided
Manager roles in Massachusetts9 roles publishing pay
Manager roles in the US44 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $151,500 | — | $215,700 |
| Massachusetts (middle half) | $149,000 | $175,000 | $177,000 |
| All US (middle half) | $150,125 | $163,000 | $175,000 |
This role: TransMedics's own published range. Comparisons: the base pay employers published on open Clinical Trial Management roles at the same level on Regulatory Jobs, November 1, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Trial Management
The general path across 69 open Clinical Trial Management roles on Regulatory Jobs, with the titles they carry most. Not TransMedics's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 57 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership14
- Clinical trial conduct11
- Documentation and SOPs8
- GMP and compliance3
- Investigations and CAPA3
- Regulatory submissions1
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
TransMedics on Regulatory Jobs
- 7
- Open roles
- 7
- Distinct roles
- 1
- Locations
By discipline
- Quality5 71%
- Regulatory1 14%
- Clinical1 14%
By level
- Associate & Specialist3 43%
- Manager2 29%
- Senior & Principal2 29%
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Principal Clinical Trial Manager at TransMedics
Open until filled. $152K–$216K a year, employer provided.