Clinical Operations Manager

vor 4 Wochen


Town Of Cambridge, Österreich TOGL (Holdings) Limited Vollzeit

About The Origin Group Ltd (TOGL) The Origin Group Limited (TOGL) is the parent organisation and technical service provider to a focused portfolio of UK‑based medical technology, research, and innovation companies. Organisations within the group include Origin Sciences, Ellele Health and Biomii. Origin Sciences is a clinical‑stage diagnostics company developing and commercialising novel medical devices for gastrointestinal diseases. Our proprietary sample collection technology underpins innovative diagnostic solutions across multiple diagnostic areas with a focus on colorectal cancer. Ellele Health, is focused on advancing women’s health by developing a novel vaginal sample collection device for gynaecological diagnostics, including the early detection of endometrial cancer. As a group, we are committed to delivering cutting‑edge diagnostic tools that empower clinicians, improve patient outcomes, and transform standards of care. Role Overview We are seeking an experienced and motivated Clinical Operations Manager to manage and oversee clinical studies across The Origin Group. This role will support both Origin Sciences’ gastrointestinal programmes and Ellele Health’s women’s health initiatives, ensuring clinical trials are delivered to the highest standards of quality, ethics, and regulatory compliance. The Clinical Operations Manager will play a key role in bridging innovation with clinical execution, working cross‑functionally and with external partners to bring transformative device and diagnostic technologies closer to patients. Key Responsibilities Lead operational planning and execution of clinical studies across both GI and women’s health programmes, from start‑up through close‑out. Lead strategic objectives and manage Clinical Research Associates dedicated to studies Oversee study timelines, budgets, and deliverables to ensure milestones are met. Develop, review, and maintain study documentation (protocols, SOPs, study manuals, reports). Ensure compliance with GCP, ICH guidelines, ISO standards, regulatory requirements, and internal policies. Act as primary point of contact for clinical sites, investigators, and partners, building strong and productive collaborations. Monitor study progress, patient recruitment, and data quality; provide regular updates to project teams and leadership. Support regulatory submissions and interactions with health authorities as required. Partner with R&D, Quality, and Regulatory teams to align study execution with scientific and strategic objectives. Contribute to building scalable processes and infrastructure for the clinical operations function across the group. Qualifications & Experience Bachelor’s degree in life sciences, nursing, pharmacy, or related field (advanced degree preferred). 5+ years’ experience in clinical operations, ideally in medical devices or diagnostics. Demonstrated success in managing clinical trials (early feasibility, pivotal, or post‑market). Deep understanding of GCP, ICH, ISO 14155, and global regulatory frameworks (MHRA, EMA). Experience managing clinical sites, including contracts and budgets. Strong project management and organisational skills with attention to detail. Excellent communication and relationship‑building skills across diverse stakeholders. Ability to work effectively in a fast‑paced, entrepreneurial environment and manage multiple programmes simultaneously. Join Us Be part of a mission‑driven group innovating in both gastrointestinal and women’s health diagnostics. Unique opportunity to contribute across two pioneering clinical pipelines. Collaborative, forward‑thinking environment within a high‑growth company. Competitive salary, benefits, and opportunities for advancement. #J-18808-Ljbffr



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