We are seeking a Senior Clinical Affairs Expert to join a pioneering diagnostics company based in Barcelona. brThis is a pivotal role acting as the primary strategic and operational bridge between the company and a leading global CRO, overseeing an ambitious multi-center clinical study across Europe and the USA. brYou will be the lead interface for daily operations, ensuring the seamless execution of a large-scale clinical performance study for a novel, breakthrough device. brExternal Partner Management: Act as the primary point of contact for the selected CRO, overseeing site selection, qualification, and training across all sites. brCross-Functional Leadership: Coordinate internal stakeholders across R D, Marketing, Regulatory, and Quality departments to align clinical strategy. brGlobal Compliance: Ensure study phases strictly adhere to EU IVDR requirements and U. S. FDA regulatory standards. brStrategic Oversight: Monitor study progress, identify risks, and implement mitigation actions for a high-volume clinical project. brFuture Planning: Contribute to the design and planning of post-market clinical follow-up studies. Education Training: brBachelor's degree in Life Sciences (Biology, Biotechnology, Pharmacy, Medicine, or similar). brAn Advanced degree (MSc, Ph D, or equivalent) is highly preferred. brSpecific training in Clinical Trial Management or Regulatory Affairs is a strong asset. Experience Skills: brIdeally 5–8 years in Clinical Project Management. High-potential candidates with 5–6 years of solid experience are also encouraged to apply. brMandatory experience in Medical Devices, with a strong preference for IVD (In Vitro Diagnostics). brFamiliarity with molecular diagnostics, PCR-based assays, or nucleic acid technologies is a plus. brFluent English is essential for daily international coordination. brHigh level of autonomy and excellent stakeholder management skills.