Clinical Trial Manager

Spectral AI, Inc.Dallas, TX
51d

About The Position

We are seeking a Clinical Trial Manager (CTM) who will be responsible for overseeing the day-to-day operations of multiple clinical trials-from initiation through close-out-working across internal teams and with external CRO partners. This role offers a unique opportunity to contribute meaningfully to trial strategy, execution, and reporting, while operating in a collaborative and fast-paced environment.

Requirements

  • Bachelor's degree in life sciences, nursing, or relevant field
  • 6+ years of experience in clinical research, including 3+ years managing trials in a sponsor or CRO environment
  • Experience managing medical device trials
  • Demonstrated ability to oversee multiple trials or various study designs simultaneously
  • Strong communication and organizational skills with high attention to detail
  • Proven track record of preparing trial updates and presenting senior leadership on study progress
  • 6+ years of clinical research experience (medical device industry strongly preferred)
  • 3+ years as a Clinical Trial Manager or similar role as part of your research experience
  • Experience managing and supporting physician investigators
  • Exceptional attention to detail - you catch what others miss
  • Proven ability to manage multiple projects in a fast-paced, dynamic environment
  • Deep knowledge of GCP, ISO 14155, and medical device regulations

Nice To Haves

  • Prior hands-on clinical research experience or nursing experience in wound care
  • Experience in early-stage environments or small companies
  • Familiarity with EDC systems, QA, and regulatory documentation and requirements

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

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What This Job Offers

Job Type

Full-time

Career Level

Mid Level

Industry

Computer and Electronic Product Manufacturing

Number of Employees

51-100 employees

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