Principal Clinical Trial Manager

TransMedics•Andover, MA

27d•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 on time and with the highest quality through thoughtful delegation of study-related tasks and assignments. This role is crucial for the successful execution of clinical trials, particularly in the context of FDA submissions and regulatory compliance.

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.