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Clinical Research Manager | Medical Device and IVD

hace 22 horas

Bilbao

Clinical Research Manager | MedTech and IVD Location: Spain, Portugal or UK (Remote with occasional in‑person activities) Employment Type: Full‑time Role Summary We are seeking an experienced Clinical Research Manager to lead and coordinate clinical studies for medical devices and in vitro diagnostics. The role covers the full clinical lifecycle, from early study design and start‑up through execution and close‑out, in compliance with GCP, ISO standards, and applicable European and local regulations. You will act as a key interface between sponsors, study sites, and internal teams, ensuring high‑quality delivery, regulatory compliance, and effective project and people management. This role also includes mentoring and development responsibilities for junior team members and consultants. Key Responsibilities You will: • Lead and manage Clinical Investigations and Performance Studies for medical devices and IVDs from start‑up to close‑out, • Ensure studies are conducted in compliance with GCP, ISO 14155, ISO 20916, EU regulations, and local requirements, • Contribute to protocol, CRF, ICF, and study documentation design and review, • Coordinate submissions to Ethics Committees and Competent Authorities, • Oversee site initiation, monitoring activities, and ongoing site management, • Maintain close communication with investigators, study coordinators, sponsors, and internal stakeholders, • Monitor project progress against timelines, quality metrics, and budgets, • Identify project risks and implement mitigation strategies in collaboration with the project team, • Act as the primary daily point of contact for sponsors, • Develop, maintain, and oversee Trial Master Files and eTMFs, • Prepare and present project status updates to internal and external stakeholders, • Negotiate contracts with study sites, vendors, and service providers, • Manage project finances according to sponsor contracts and approved budgets, • Provide input into proposals, budgets, and bid defense activities, • Ensure adherence to QMS procedures and contribute to continuous improvement initiatives, • Participate in Management Review activities as required People Development and Team Responsibilities You will also: • Support onboarding of new team members by providing guidance, tools access, and structured induction, • Coordinate and follow initial training plans for assigned employees or consultants, • Conduct periodic performance evaluations and development discussions, • Review training effectiveness and contribute to continuous professional development planning, • Support definition and follow‑up of individual training and growth plans Requirements Must‑Have • 1–3 years of professional experience as a Clinical Project Manager or Clinical Research Manager in medical devices or IVDs, • Solid working knowledge of GCP and clinical research standards, • Bachelor’s degree in Life Sciences, • Advanced written and verbal English (C1–C2 level or equivalent), • Ability to manage multiple projects and stakeholders in an international environment, • Availability for remote work with occasional in‑person activities Nice to Have • Master’s degree in Life Sciences, • PhD or advanced scientific training in a medical or related discipline, • Experience with ISO 14155 and or ISO 20916, • Fluency in additional EU languages, • Experience supporting audits or inspections Why Join MDx CRO At MDx CRO, you will join a highly specialised and rapidly growing organisation recognised across the MedTech and IVD sector. We offer a professional, collaborative environment where expertise is valued and continuous development is encouraged. You will benefit from: • Exposure to complex and meaningful clinical projects, • A high level of autonomy and responsibility, • Close collaboration with senior regulatory and clinical experts, • Opportunities for professional and career growth About MDx CRO MDx CRO is a leading Contract Research Organisation specialising in in vitro diagnostics and medical devices. We support clients through regulatory strategy, clinical research, and quality assurance, enabling safe and effective technologies to reach patients worldwide. Our Principles • Make it POSSIBLE, • Make it WIN‑WIN, • Keep IMPROVING, • Keep GROWING, • Keep it DIVERSE Our Vision To democratise access to world‑class regulatory and clinical strategies, ensuring safer and more effective medical technologies for all. Our Mission We pioneer emerging technologies and navigate uncharted territories to redefine the future of the medical sector. Grow with Us If you are looking to take ownership of clinical projects and grow within a specialised and expert‑driven CRO, we would be pleased to hear from you.

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