Principal Clinical Trial Manager

TransMedics, Inc.•Andover, MA

1d•$137,100 - $193,700•Hybrid

About The Position

The Principal Clinical Trial Manager provides leadership in the development of clinical trial activities and ensures that clinical trials are completed in a timely manner and with the highest quality through thoughtful delegation of study-related tasks and assignments. This role is responsible for leading the process of pre and post-market clinical trials for the FDA, creating study-specific templates, managing the clinical monitoring process, and overseeing the drafting of annual and bi-annual reports to the FDA. The position also involves leading all clinical site interactions, owning trial start-up, conduct, and close-out activities, and contributing expertise to the preparation of key clinical documents. The Principal Clinical Trial Manager will establish professional rapport with investigational site personnel, track internal metrics, timelines, and budgets, and communicate trial status to the team and management. They will also oversee and participate in monitoring activities to ensure adherence to GCP and ICH guidelines, interact with data management, support applications, collaborate with committees, and assist with investigators’ meetings and vendor management.

Requirements

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

Nice To Haves

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

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.