Clinical Trial Manager 2 - Contractor

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RESPONSIBILITIES

This position is responsible for, but not limited to, the following:

• Manage clinical site interactions (including assistance with IRB/EC applications, contract negotiations, enrollment tracking, clinical trial material and clinical supply requests, issue resolution, etc.)

• Manage trial start-up, conduct, and close-out activities according to industry and corporate standards with Director support

• Prepare key clinical documents (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 Director, Program Managers and Senior Management

• Participate in monitoring activities at clinical trial sites to assure adherence to GCP and ICH guidelines, regulatory requirements, SOPs, protocols and ensure that data is complete and accurate

• In conjunction with data management personnel, gain understanding of planning, monitoring, and executing 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 will not have management responsibilities.

MINIMUM QUALIFICATIONS

• 5+ years experience as Research Associate, Clinical Trail Assistant, Clinical Trial Coordinator, CRA or equivalent combination of education and experience

• Experience coordinating external and internal documentation for clinical trials

• Experience interacting with sites, monitors, IRB's, sponsors, vendors, clinical centers, and FDA

• Experience screening and recruiting patients for studies

• Knowledge of adverse event investigation, analysis and reporting procedures and standards

• Proficiency with electronic data management systems

• Familiarity with clinical budget planning and management

• Understanding of data collection methodologies

• Familiarity with GCP, ICH, ISO and FDA regulatory requirements

• Experience in coordinating multi-center global clinical trials

• Ability to build collaborative relationships both internally and externally

• Willing to be held accountable for deliverables

• Must be highly organized and detail oriented

• 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

• BA/BS in Science, Life Sciences or relevant field; or equivalent combination of education and experience

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.