Clinical Study Manager (Medical Devices)

Are you an experienced Clinical Study Manager with EU medical device trial expertise Want to play a pivotal role in bringing innovative medical devices to market Apply now to make a difference!

Amber Therapeutics are looking for a Clinical Study Manager to make a real impact on patients lives as we develop a closed-loop neuromodulation therapy to treat mixed urinary incontinence. This is a full-time hybrid role (c. one day a week onsite in Harwell Oxfordshire) with regular travel to the Europe and occasional travel to the US.

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

Essential

• Bachelors 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.

Desirable

• Experience with active implantable devices and/or neuromodulation therapy.
• Experience in UI therapeutic area.
• Site management / field support experience.
• Premarket trial experience.
• An additional European language

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 fully implantable PicostimTMSystem targets the pudendal nerve with a device that can both stimulate and sense physiological responses. The therapy is configurable to the individuals 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 Companys 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 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.

Required Experience:

Manager