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Spectral AI · 2 weeks ago

Clinical Trial Manager

Dallas, TX

Full-time

Onsite

Senior Level

6+ years exp

Spectral AI is seeking a Clinical Trial Manager (CTM) who will oversee the day-to-day operations of multiple clinical trials. The role involves managing trials from initiation through close-out, ensuring regulatory compliance, and coordinating with internal and external stakeholders.

AnalyticsArtificial Intelligence (AI)BiotechnologyHealth CareMachine LearningMedical Device

Responsibilities

Manage the planning, execution, and oversight of clinical trials (both internally managed and CRO-managed) in alignment with company goals, timelines, and budgets

Manage CRAs, internal or externally, for the execution of clinical trials

Serve as primary contact for internal stakeholders, CROs, and investigational sites

Ensure regulatory compliance, GCP adherence, and proper documentation throughout the trial lifecycle

Coordinate closely with investigative physicians and site staff, supporting protocol compliance and patient safety

Ensure meticulous attention to data accuracy, study documentation, and trial conduct

Overseeing and managing the trial budget and ensuring efficient use of resources

Track trial progress and proactively identify and mitigate risks or delays, proactively resolve operational issues

Generate regular status updates and presentations for leadership, including timelines, enrollment metrics, and key performance indicators

Assist in the creation and review of protocols, CRFs, training materials, regulatory documents, site audits, and quality processes

Cross-team collaboration regarding data management, finances, engineering to ensure proper communication and deliverables are met

Travel up to 30% for site visits, investigator meetings, and industry conferences, as they arise

Travel (approximately) once a month for in-office collaboration

Help field and respond to clinical questions based on your practical experience

Qualification

Clinical trial managementGCP knowledgeMedical device trialsEDC systems familiarityRegulatory documentationCommunication skillsOrganizational skillsAttention to detail