Clinical Trial Manager

City: Columbia, MD

Country/Region: United States

State:

Business Area: Clinical Research

Department: Clinical Affairs

Employment Type: Full-time

Req ID: 10220

Job Title: Clinical Trial Manager

Reports to: Director, Clinical Data Acquisition (TBD)

Location: Remote or Columbia, MD

POSITION SUMMARY

Ambu is advancing the future of endoscopy through data-driven innovation. As part of our growing Clinical Data Acquisition team, the Clinical Trial Manager will play a critical role in generating the high-quality clinical data needed to support the development of Ambu's next generation of AI-powered Endointelligence solutions.

Unlike traditional pharmaceutical clinical trial roles, this position focuses on the planning, execution, and oversight of medical device clinical studies designed to acquire clinical data that supports product innovation, algorithm development, and clinical validation. Working cross-functionally with Clinical Affairs, R&D, Software Engineering, Regulatory Affairs, Quality, and Commercial teams, the Clinical Trial Manager will manage clinical studies from planning through closeout while ensuring compliance with applicable regulatory requirements, quality standards, and study timelines. This is a highly collaborative, hands-on role with significant interaction across internal teams, clinical sites, and external partners. As part of a newly established function, this individual will also help build scalable processes and contribute to the continued growth of Ambu's clinical data capabilities.

ESSENTIAL FUNCTIONS & RESPONSIBILITIES

• Lead the planning, execution, monitoring, and close-out of clinical studies in accordance with ISO 14155, Good Clinical Practice (GCP), and applicable regulatory requirements.
• Partner with cross-functional stakeholders to support protocol development, study design, and operational planning.
• Identify, qualify, initiate, and manage clinical study sites across North America and Europe, as needed.
• Perform or oversee site monitoring activities, including coordination with Contract Research Organizations (CROs) when applicable.
• Serve as the primary operational liaison between clinical sites, investigators, internal stakeholders, and external vendors.
• Support study budgets, contracts, site agreements, and vendor management in collaboration with internal partners.
• Monitor enrollment, site performance, study milestones, and overall study progress while proactively identifying and resolving operational challenges.
• Maintain study documentation and ensure compliance with internal quality systems, regulatory standards, and applicable SOPs.
• Contribute to the development, implementation, and continuous improvement of Clinical Operations processes and Standard Operating Procedures (SOPs).
• Support internal and external audits and regulatory inspections as required.
• Provide regular study status updates, risk assessments, and recommendations to project stakeholders.
• Travel to investigator sites as needed to support study execution and monitoring activities.

QUALIFICATIONS

REQUIRED:

• Bachelor's degree in Life Sciences, Nursing, Biomedical Engineering, or another relevant scientific discipline.
• Several years of clinical operations or clinical trial management experience within the medical device, biotechnology, or healthcare industry.
• Strong working knowledge of ISO 14155 and Good Clinical Practice (GCP) requirements for medical device clinical investigations.
• Experience managing investigator sites, study monitoring, and overall clinical study execution.
• Demonstrated ability to manage multiple studies and priorities simultaneously.
• Strong organizational, project management, and stakeholder management skills.
• Excellent written and verbal communication skills.
• Ability to work effectively within a global, cross-functional organization.

PREFERRED:

• Experience supporting AI-enabled medical technologies, digital health, imaging, or software-based medical devices.
• Experience working with Contract Research Organizations (CROs) from either the sponsor or vendor perspective.
• Exposure to protocol development, regulatory submissions, or clinical study design.
• Experience supporting global or multi-center clinical studies.

WHO YOU ARE

• You are a proactive and collaborative clinical operations professional who enjoys building new capabilities and solving complex challenges.
• You balance strong attention to detail with the ability to see the bigger picture and thrive in dynamic, cross-functional environments.
• Take a practical, solution-oriented approach while maintaining regulatory compliance.
• Build trusted relationships with investigators, clinical sites, and internal stakeholders.
• Communicate effectively across technical and non-technical teams.
• Enjoy working in fast-paced environments where processes continue to evolve.
• Are motivated by improving patient care through innovation and high-quality clinical data.

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