Our client, headquartered pharmaceutical company in Spain which is working at a complete international level is looking for a Clinical Quality Assurance Coordinator to ensure clinical trials (phase I-IV) compliance.
|Our client, headquartered pharmaceutical company in Spain which is working at a complete international level is lookikng for a Clinical Quality Assurance Coordinator to ensure clinical trials (phase I-IV) compliance.
Plays a leadership role in maintaining the company's Clinical Quality Assurance (CQA) group focused on Good Clinical Practice (GCP) compliance
Minimum BS/BA degree in biological sciences, chemistry, or related field
3-4 years of progressive pharmaceutical experience in a clinical development area and related to QA activities
Minimum exposure of regulatory authority inspections and inspection readiness preferred
Excellent working knowledge and understanding of GCP-related requirements and proficiency of regulatory and ICH guidelines.
Excellent verbal and written communication skills,
Ability to work well in teams and independently
Ability to prioritize work, manage multiple projects while maintaining quality and advocate for compliance
Highly diplomatic and tactful individual with exceptional critical reasoning skills who is detail oriented
Previous monitoring experience CRA I-II is a must
Travelling availability (40-60%) worldwide is required our client is currently running phase I and phase III trials Europe and EUA.