We are seeking aSenior Clinical Affairs Expertto join a pioneering diagnostics company based inBarcelona. This 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 acrossEurope and the USA.You will be the lead interface for daily operations, ensuring the seamless execution of a large-scale clinical performance study for a novel, breakthrough device. External Partner Management:Act as the primary point of contact for the selected CRO, overseeing site selection, qualification, and training across all sites. Cross-Functional Leadership:Coordinate internal stakeholders across R&D, Marketing, Regulatory, and Quality departments to align clinical strategy. Global Compliance:Ensure study phases strictly adhere toEU IVDRrequirements andU.S. FDAregulatory standards. Strategic Oversight:Monitor study progress, identify risks, and implement mitigation actions for a high-volume clinical project. Future Planning:Contribute to the design and planning of post-market clinical follow-up studies.Education & Training: Bachelor's degree in Life Sciences(Biology, Biotechnology, Pharmacy, Medicine, or similar). AnAdvanced degree(MSc, PhD, or equivalent) is highly preferred. Specific training inClinical Trial ManagementorRegulatory Affairsis a strong asset.Experience & Skills: Ideally5–8 yearsin Clinical Project Management. High-potential candidates with5–6 yearsof solid experience are also encouraged to apply. Mandatory experience inMedical Devices, with a strong preference forIVD (In Vitro Diagnostics). Familiarity with molecular diagnostics, PCR-based assays, or nucleic acid technologies is a plus. Fluent Englishis essential for daily international coordination. High level of autonomy and excellent stakeholder management skills.