Principal Clinical Trial Manager

Principal Clinical Trial Manager

The Principal Clinical Trial Manager provides leadership in the development of clinical trial activities and ensures that clinical trials are completed in time and with the highest quality with thoughtful delegation of study related tasks and assignments.

Responsibilities

• 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

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 $137,100.00 $193,700.00, 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.