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

Clinical Study Manager (Medical Devices)

Hybrid

Clinical Affairs

Full time

Permanent

The Role

As Clinical Study Manager, you will take ownership of the operational delivery of international clinical studies, ensuring they are executed on time, within budget and in compliance with study protocols, Good Clinical Practice, ISO 14155 and internal quality standards. Working in a fast-paced, collaborative environment, you will lead cross-functional teams, manage external vendors and clinical sites, and act as the primary operational contact for stakeholders throughout the study lifecycle. You will drive site performance, patient recruitment, data quality and proactive risk management, ensuring issues are identified and resolved quickly to keep studies on track. This is an exciting opportunity to play a key role in bringing innovative medical technologies to patients, with regular travel across Europe to support clinical trial sites and our Belgium office, and occasional travel to the US to support clinical sites and patient visits.

Key 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, implementing solutions to overcome challenges.
• Ensure compliance with study protocols, Good Clinical Practice (GCP), ISO 14155, regulatory requirements and company SOPs.
• Coordinate study communications and provide regular progress updates to senior leadership.
• Oversee data cleaning, analysis, study results generation, device supply and trial logistics.
• Collaborate cross-functionally to support product improvements, technical investigations and issue resolution.
• Build and maintain strong relationships with investigators, key opinion leaders and clinical sites.
• Become a subject matter expert in study protocols and the use of investigational devices.
• Provide operational support for clinical sites, including site and patient visits where required.
• Support audit readiness, inspections, data integrity and timely resolution of data queries.
• Provide guidance to internal teams and site staff, supporting protocol and device training where appropriate.
• Travel regularly throughout Europe, with occasional travel to the US, to support clinical trial activities.

Skills & Experience

• Bachelor’s degree in a scientific or health-related field or equivalent.
• Extensive experience in clinical trial management in medical devices.
• Experience of set-up, management and closeout of EU CE mark trials.
• Strong knowledge of GCP and ISO14155.
• Proven experience in vendor oversight and cross-functional leadership.
• Excellent written and oral communication skills.
• Effective team-player, agile and thrives in versatile environment.
• Experience with active implantable devices and/or neuromodulation therapy.
• Experience in UI therapeutic area.
• Site management / field support experience.
• Premarket trial experience.

About Us

Amber Therapeutics is developing a closed-loop neuromodulation therapy able to treat mixed urinary incontinence for the first time and transform the clinical outcome of a very large untreated patient population.Amber’s fully implantable PicostimTMSystem targets the pudendal nerve with a device that can both stimulate and sense physiological responses. The therapy is configurable to the individual’s need and able to respond dynamically to different events, adapting as needed between modes of operation. This principle can be used in broader functional disorders of the nervous system that the Company’s academic partnerships are exploring.

What We Offer

This is a chance to be part of a ground-breaking team creating life-changing therapies for millions of people globally. You join us at an exciting phase of our development, as we expand the team and accelerate towards our first Pivotal Trial. In addition, we offer a competitive salary commensurate with experience, private healthcare, income protection, life assurance, company pension scheme, equity scheme and 27 days holiday (plus bank holidays).

Amber Therapeutics is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We look forward to hearing from you.

Competitive

Hours

40 hours per week

Private healthcare, pension, income protection, life assurance, 27 days holiday + bank holidays, equity scheme