TransMedics
Principal Clinical Trial Manager
Andover, MA · Principal
Sponsorship not specified$137k-$194kDetected 7 days ago
GCPStatisticsBudgetingRecruitingClinical TrialsPatient CareFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationProblem SolvingPublic SpeakingOrganizational Skills
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Lottery odds (Level IV)94
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About the role
- The Principal Clinical Trial Manager provide leadership in the development of clinical trial activities and ensure that clinical trials are completed in time and with the highest quality with thoughtful delegation of study related tasks and assignments.
Responsibilities
- 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.)
- Support applications and technical files as needed
- Collaborate with project specific committees (e.g., DSMB, CEC)
- This position manages the following positions on a daily basis.
Requirements
- Perform other TransMedics tasks and duties as assigned/required.
Nice to have
- Masters in Science, Life Sciences or relevant field
- 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
Compensation
- Provide oversight of drafting all annual and bi-annual pre and post market reports to FDA in collaboration with the regulatory team
Company info
- Our mission is to help save more patients' lives by increasing access to viable donor organs for those who are awaiting an organ transplant.
- 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.
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This listing is sourced directly from TransMedics's careers page and normalized into a canonical job model.