Principal Clinical Trial Manager

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
• Create study specific templates across all programs
• Manage 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)
• Aid in preparation for investigators’ meetings
• Work with vendors as needed
• Perform other TransMedics tasks and duties as assigned/required.

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