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 integral 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, PhD, 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.
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