Busqueda Urgente Clinical Study Coordinator

In a nutshell

Position : Clinical Study Coordinator

Location : Madrid, Hibrid

Experience : 4+ years in international clinical trial coordination

Want 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?