Global Clinical Study Manager, Medical Devices

Amber Therapeutics; East Hagbourne; Hybrid; GBP 70,000 - 110,000; Full time

Benefits offered by this job

Private healthcare

Income protection

Life assurance

Company pension scheme

Equity scheme

27 days holiday

Job summary

Amber Therapeutics is seeking a Clinical Study Manager (Medical Devices) to lead international clinical studies from start to closeout. You will manage CROs, vendors and sites, ensure compliance with GCP and ISO 14155, and drive recruitment, data quality and risk mitigation across Europe and the US.

The role is hybrid, with frequent travel to Europe and occasional travel to the US, reporting into Clinical Affairs. A strong background in medical device trials and CE mark experience is essential.

Qualifications

• Bachelor’s degree or equivalent in a scientific/health-related field.
• Extensive experience in clinical trial management for medical devices.
• Experience with EU CE mark trial setup, management and closeout.
• Strong knowledge of GCP and ISO 14155 regulations.
• Vendor oversight and cross-functional leadership capabilities.
• Excellent written and oral communication skills.

Responsibilities

• Lead study start-up activities including site selection, qualification and activation.
• Manage CROs, vendors and third-party suppliers to ensure high-quality, timely delivery.
• Monitor site performance, patient recruitment and operational progress; implement solutions.
• Ensure compliance with study protocols, GCP, ISO 14155 and regulations; follow SOPs.
• Coordinate study communications and provide regular progress updates to senior leadership.
• Oversee data cleaning, analysis, results generation, device supply and trial logistics.
• Collaborate cross-functionally to support product improvements and investigations.
• Build relationships with investigators, key opinion leaders and clinical sites.
• Become subject matter expert in study protocols and investigational devices usage.
• Provide operational support for clinical sites, including site/patient visits.
• Support audit readiness, inspections, data integrity and queries resolution.
• Provide guidance to internal teams and site staff on protocol/device training.
• Travel across Europe regularly; occasional travel to the US.

Skills

Clinical trial management

Vendor oversight

Cross-functional leadership

GCP

ISO 14155

Communication skills

Site management

Study start-up

Risk management

International trials

Education

Bachelor’s degree in science/health

EU CE mark trials experience

Premarket trial experience

Job description

Amber Therapeutics is seeking a Clinical Study Manager (Medical Devices) to lead international clinical studies from start to closeout. You will manage CROs, vendors and sites, ensure compliance with GCP and ISO 14155, and drive recruitment, data quality and risk mitigation across Europe and the US.

The role is hybrid, with frequent travel to Europe and occasional travel to the US, reporting into Clinical Affairs. A strong background in medical device trials and CE mark experience is essential.