Clinical Study Coordinator

hace 5 días

Cequelinos, España mAbxience A tiempo completo

In a nutshell Position: Clinical Study CoordinatorLocation: Madrid, HibridExperience: 4+ years in international clinical trial coordinationWant to know more? mAbxience is a global biopharmaceutical company committed to innovation and excellence in the development and manufacturing of biotechnological medicines. We operate with a strong focus on quality, regulatory compliance, and scientific rigor to improve patient outcomes worldwide.What are we looking for? Oversee and ensure the proper execution and follow-up of clinical trials, managing CROs and vendors to meet timelines, quality standards, and regulatory requirements.Design and manage clinical trial plans, identifying risks and implementing corrective actions.Coordinate site and investigator selection, budget management, and vendor contracts.Ensure compliance with GCP, FDA, EMA, ICH guidelines, and internal procedures.Manage regulatory documentation and submissions, maintaining audit readiness.Supervise clinical trial monitoring, investigational product handling, and patient recruitment strategies.Collaborate with pharmacovigilance teams to ensure timely reporting and management of safety events.Support quality management through monitoring reports, deviation handling, and protocol amendments.Maintain effective communication with internal teams, CROs, investigators, and regulatory authorities.What do you need?

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