Note: The job is a remote job and is open to candidates in USA. Ambu is advancing the future of endoscopy through data-driven innovation. The Clinical Trial Manager will manage clinical studies from planning through closeout while ensuring compliance with regulatory requirements and quality standards, working collaboratively with various internal teams and external partners.
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
Skills
- 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
- 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
Company Overview