QARA Senior Clinical Affairs en Barcelona.
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Carla Barreiro Marco
Contactarour client
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.
your functions
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.
position requisites
-
Formación
: Grado: Grado en Ciencias Biomédicas -
Conocimientos
: ivd, clinical trials management -
Experiencia
: 5 años
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.
your benefits
Compensation: Competitive salary package based on experience and seniority.
Project Scale: Lead a large-scale international study for a product already approved.
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