Main responsibilities
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* Support Roche clinical studies and play a role in the development of new diagnostic tests, helping to ensure the quality and safety of our products.
* Perform quality review of clinical study documents (study protocols, investigator brochures and reports) to ensure that clinical studies of IVDs are planned, conducted, and documented in compliance with regulations, internal procedures and product specification documents.
* Support GCP inspection readiness activities, including through study file reviews.
* Support team initiatives, including process improvement/harmonization.
* Support project teams with Good Clinical Practice expertise.
Additional responsibilities
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* Additional tasks as required.
Requirements
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* Preferred education: Recent graduates from a University degree or Master in a scientific or technological discipline, ideally in Biomedicine or Biotechnology.
* No previous experience needed.
* Fluent command of English.
* Interest in clinical studies, medical devices, quality management systems and software development processes. Knowledge of quality and regulatory standards is a plus but not mandatory: Good Clinical Practice (GCP), ISO 13485, ISO 20916, FDA QSR, IVDR, GDPR.
* This position is only available for candidates who have never worked in a company in Spain or used a "contrato de prácticas" before. xpzdshu
Roche is an Equal Opportunity Employer.
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