Do you have experience in clinical operations within medical devices? Do you have a passion for improving patients’ lives with new medical technology? We want to hear from you Amber Therapeutics are looking for an EU Clinical Operations Manager to make a real impact on patients’ lives as we develop a fully adaptive neuromodulation therapy to treat mixed urinary incontinence. This is a hybrid full-time, permanent role to be based between your UK home address and one day a week at our brand-new facility in Oxfordshire, UK (due to open mid 2025) with regular travel within the UK & Europe to clinical trial sites. The Role An exciting opportunity to work in a new role managing Amber’s new EU clinical operations team, you will ensure clinical trials are being managed to objectives, timelines, budget and quality expectations. This role will involve travel throughout Europe to support the opening of new clinical trial sites, as well as support trial surgical cases and patient follow-up visits when required (possibly at short notice). Responsibilities include clinical evaluation reports, implementing new procedures within the clinical function, reporting to senior management as well as collaboration with the US Head of Clinical Operations on joint US/EU trials. Key Responsibilities: Management of Amber’s EU Clinical Operations Team. EU trial management, trial budgeting, resourcing and clinical quality. Delivery of on-time clinical yrial submission, trial start-up and clinical trial recruitment. Oversight of Amber’s academic clinical collaboration trials. Responsible for compiling the regulatory body document packs for clinical trial applications. Developing & maintaining Clinical Evaluation Reports (CER) and Clinical Evaluation Plans (CEP). Data analysis and reporting of clinical trials. Provide clinical trial updates, including trial status and metrics, budget, accomplishments and risks to senior management on a regular basis. Develop and maintain departmental procedures in line with regulatory requirements. Collaborate with the VP Clinical Quality Regulatory on Clinical Operations Department budgeting. Coordinating trial support and ensure team develops and delivers training as appropriate. Vendor Management: implementing clinical supplier selection processes, selection & management of CRO’s. Representing the company e.g. with key opinion leaders, principal investigator. Clinical trial onsite support: developing relationships with Principal Investigators and Key Opinion Leaders & EU travel to support site initiation, surgical cases and patient follow-up visits. Compliance and regulatory activities including compiling clinical trial submissions (in collaboration with cross-functional teams) for FDA, EU Competent Authorities and Ethics Committee/IRB, clinical trial adverse event reporting, clinical study reports. Quality activities including ensuring appropriate clinical quality assurance standards at participating trial sites and within Amber, contributing to the preparation and management of clinical audits & in the Amber Complaints and AE Review Board. Essential Skills & Experience Bachelor's degree in a scientific or health-related field. Extensive experience in clinical operations in medical devices, either with a medical device company or CRO. Experience of managing a Clinical Operations team. Experience of selecting and managing CROs. Expert knowledge of GCP's, FDA regulations, EU MDR and ISO14155. Demonstrable leadership and project management skills. Experience of working closely with Principle Investigators and building relationships with clinical trial site staff. Desirable Skills & Experience: Masters/PhD degree in a scientific or health-related field. Experience of set-up, management and closeout of EU CE mark trials. Experience of writing Clinical Evaluation Plans and Reports. With strong leadership skills to drive engagement and optimise team performance, you should have the ability to foster strong relationships with internal and external stakeholders. This role requires the ability to work on multiple projects in a fast-paced environment as well as excellent verbal and written communication skills. About Us Amber Therapeutics is developing a fully adaptive 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 Picostim TM System 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 and 27 days holiday (plus bank holidays). Amber Therapeutics is an equal opportunities employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We look forward to hearing from you.