Principal Clinical Trial Manager

Job Description:

POSITION SUMMARY

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.

RESPONSIBILITIES

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

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 QUALIFICATIONS

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.

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.