We are seeking a Senior Clinical Affairs Expert to join a pioneering diagnostics company based in Barcelona. 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 across Europe 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 to EU IVDR requirements and U. S. FDA regulatory 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). An Advanced degree (MSc, Ph D, or equivalent) is highly preferred. Specific training in Clinical Trial Management or Regulatory Affairs is a strong asset.
Experience & Skills:
Ideally 5–8 years in Clinical Project Management. High-potential candidates with 5–6 years of solid experience are also encouraged to apply. Mandatory experience in Medical Devices, with a strong preference for IVD (In Vitro Diagnostics). Familiarity with molecular diagnostics, PCR-based assays, or nucleic acid technologies is a plus. Fluent English is essential for daily international coordination. High level of autonomy and excellent stakeholder management skills.