Clinical Trial Manager

Position Summary

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.

Essential Duties and 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

Qualifications

Required:

• 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

Preferred:

• 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

Knowledge, Skills, and Abilities:

• 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

Physical Requirements:

The physical demands described below are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Very limited physical effort required to perform normal job duties
• Extensive use of telephone, virtual/video conference calls, and face-to-face communication requiring accurate perception of speech
• Extensive use of keyboard requiring repetitive motion of fingers
• Regular sitting for extended periods of time
• Some travel may be required

Equal Employment Opportunity:

Spectral AI, Inc. is an equal opportunity and affirmative action employer. All applicants will be considered for employment without regard to race, color, ancestry, national origin, sex, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws