Study Start Up Manager, Iqvia Biotech - Barcelona

In this role you lead global study start-up, site activation, and regulatory activities to ensure compliant, timely delivery of clinical trials. You will align cross-functional teams, manage timelines and budgets, and oversee regulatory submissions across regions. You’ll mentor teams, support business development, and optimize processes within CTMS and other systems. This is a high-impact, global position shaping how trials start up and scale to drive patient outcomes.

• Lead global and regional site activation and regulatory activities from start-up through maintenance
• Develop and execute start-up strategies and regulatory submission approaches to meet timelines
• Oversee regulatory submissions, ethics approvals, essential documents, contracts, and site activation deliverables
• Provide strategic guidance on regulatory requirements and country-specific risk mitigation
• Collaborate cross-functionally with project teams, sponsors, and regional stakeholders
• Monitor study progress, quality metrics, timelines, budgets, and resource utilization
• Maintain accurate project information within CTMS and other tracking systems
• Mentor and coach team members to promote operational excellence
• Support business development activities including bid defenses and client presentations
• Bachelor's degree in Life Sciences or a related field
• Minimum 7 years of experience in clinical research, study start-up, regulatory affairs, or related scientific environment (international experience)
• Strong knowledge of clinical trial regulations, GCP, ICH guidelines, and drug development process
• Proven experience managing complex, multi-country clinical trial start-up activities
• Excellent leadership, stakeholder management, negotiation, communication, and presentation skills
• Strong financial, project management, and organizational capabilities
• Ability to manage multiple priorities and deliver results via cross-functional teams
• Proficiency with CTMS and other clinical research systems and technologies
• leadership
• Regulatory affairs knowledge

#J-18808-Ljbffr