Study Start Up Manager, Iqvia Biotech - Barcelona

Iqvia; Barcelona; Presencial; EUR 90.000 - 120.000; Jornada completa

Descripción de la vacante

IQVIA is seeking a senior professional to lead global study start-up, site activation, and regulatory activities. You will coordinate cross-functional teams, align timelines and budgets, and oversee regulatory submissions across regions to ensure timely delivery of clinical trials.

You will mentor teams, support business development, and optimize processes within CTMS and related systems, influencing how trials scale and drive patient outcomes.

Formación

• Bachelor's degree in Life Sciences or related field.
• Minimum 7 years of experience in clinical research, study start-up, regulatory affairs, or related scientific environment.
• Experience across multi-country clinical trial start-up and regulatory submissions.
• Strong knowledge of GCP, ICH guidelines, and the drug development process.
• Excellent leadership and stakeholder management, negotiation, communication and presentation skills.

Responsabilidades

• 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.

Conocimientos

Leadership

Stakeholder management

Negotiation

Communication

Presentation

Project management

Financial acumen

CTMS proficiency

Regulatory affairs

International experience

GCP/ICH knowledge

Educación

Bachelor's degree in Life Sciences

Herramientas

CTMS

Regulatory filing systems

Descripción del empleo

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