Senior Clinical Trial Manager (Contract)

Job Description:

POSITION SUMMARY

The Senior Clinical Trial Manager (Contract role) will be responsible for overseeing all operational phases of clinical research, from start-up to database lock, ensuring studies are completed on time, within budget and in compliance with ICH-GCP guidelines and regulations.

RESPONSIBILITIES

This position is responsible for, but not limited to, the following: 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, 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 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 Travel up to 25% of the time 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

This is a standard office position

MINIMUM QUALIFICATIONS 8-10

years experience in medical device (strongly preferred), pharmaceutical drug development, biotech or CRO industries 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 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

PREFERRED QUALIFICATIONS

Masters in Science, Life Sciences or relevant field; or equivalent combination of education and experience Proven expertise in executing IRB/EC submissions and approvals 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 BA/BS in Science, Life Sciences or relevant field 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. www.

TransMedics.com

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. Welcome to TransMedics Careers! Our Vision is to help save more patients' lives by becoming the trusted partner to transplant stakeholders worldwide and delivering the highest quality technology, service and clinical care. TransMedics Group, Inc. (TMDX) is a commercial-stage medical technology company transforming organ transplant therapy for end-stage organ failure patients across multiple disease states. We developed the Organ Care System, or the OCS™, to replace a decades-old standard of care that we believe is significantly limiting access to life-saving transplant therapy for hundreds of thousands of patients worldwide. Our innovative OCS technology replicates many aspects of the organ's natural living and functioning environment outside of the human body. As such, the OCS represents a paradigm shift that transforms organ preservation for transplantation from a static state to a dynamic environment that enables new capabilities, including organ optimization and assessment. In concert with our OCS technology platform and OCS Connect™ app, which enables TransMedics and transplant clinicians to efficiently track, coordinate & communicate resource logistics for donor organs procured and maintained on OCS™, TMDX launched its National OCS™ Program (NOP) in 2022: 16 regional hubs across the U.S. staffed by a dispersed workforce of experienced, on-staff OCS Perfusion Specialists & Cardiothoracic and Abdominal Donor Procurement Surgeons. These resources are mobilized on-demand via our own dedicated ground & aviation transportation logistics network, to retrieve and deliver allocated donor organs from anywhere in the U.S. - aiding U.S. Transplant Centers in bidding farewell to the time & distance limitations of cold storage & expand the pool of viable donor organs for their transplant recipients.