Clinical Study Manager (Medical Devices)Amber Therapeutics is seeking a Clinical Study Manager to lead and oversee clinical studies for our innovative medical devices. This role is pivotal in ensuring the successful execution of clinical trials, from planning through to completion, while maintaining the highest standards of quality and compliance.
Key Responsibilities- Develop and manage clinical study protocols, timelines, and budgets.
- Coordinate with clinical sites, investigators, and regulatory bodies.
- Oversee patient recruitment, data collection, and study monitoring.
- Ensure compliance with ISO 14155, GCP, and other applicable regulations.
- Lead cross-functional teams to achieve study milestones.
- Prepare and present study progress reports to stakeholders.
Qualifications- Bachelor's degree in life sciences, nursing, or related field; advanced degree preferred.
- Minimum of 5 years of clinical research experience, with at least 2 years in medical devices.
- Strong knowledge of clinical trial design, regulatory requirements, and data management.
- Excellent project management, communication, and leadership skills.
- Experience with EU MDR and FDA regulations is a plus.
Benefits- Competitive salary and benefits package.
- Opportunity to work on cutting-edge medical technologies.
- Collaborative and innovative work environment.
- Professional development and career growth opportunities.
Amber Therapeutics is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. 
