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?