TransMedics
Clinical Trial Manager
Andover, MA
Sponsorship not specified$112k-$140kDetected 7 days ago
GCPStatisticsBudgetingRecruitingClinical TrialsPatient CareFDA RegulatoryMedical DevicesCommunicationCollaborationOrganizational Skills
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33Unrated
Cap-exempt (no lottery)0
Sponsors this role0
Entry-level history0
PERM / green-card track0
Lottery odds (Level III)83
Fits your clock70
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About the role
- This Clinical Trial Manager role is responsible for leading the end-to-end execution of clinical trials, ensuring studies are delivered on time, within budget, and in compliance with regulatory and corporate standards.
Responsibilities
- Lead for the end-to-end clinical trial delivery
- Manage trial start-up, conduct, and close-out activities according to industry and corporate standards with Director support
- Manage clinical site interactions (including assistance with IRB/EC applications, contract negotiations, enrollment tracking, clinical trial material and clinical supply requests, issue resolution, etc.)
- Support applications and technical files as needed
- Collaborate with project specific committees (e.g., DSMB, CEC)
Requirements
- 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
- Familiarity with GCP, ICH, ISO and FDA regulatory requirements
- Experience in coordinating multi-center global clinical trials
- 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
Compensation
- 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.)
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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