Global Study Start-Up Lead

IQVIA; Barcelona; Presencial; EUR 90.000 - 130.000; Jornada completa

Descripción de la vacante

IQVIA Biotech seeks an experienced Study Start-Up Manager to lead site activation, regulatory, and maintenance activities for global studies. You will drive start-up strategies, timelines, resources, and budgets while ensuring compliance and quality across trials.

Strong leadership and cross-functional collaboration are required. The role requires 7+ years in clinical research or regulatory affairs, with international experience, proficiency in CTMS, and the ability to manage multi-country

Formación

• Bachelor's degree in Life Sciences or related field.
• 7+ years of experience in clinical research, study start-up, regulatory affairs, or related scientific environment, including international experience.
• Strong knowledge of clinical trial regulations, GCP, ICH guidelines, and the drug development process.
• Proven experience managing complex, multi-country clinical trial start-up activities.
• Proficiency with CTMS and other clinical research systems and technologies.

Responsabilidades

• Lead global and regional site activation and regulatory activities from study start-up through maintenance phases.
• Develop and execute study start-up strategies, project plans, and regulatory submission approaches to achieve study timelines.
• Oversee regulatory submissions, ethics approvals, essential documents, contracts, and site activation deliverables.
• Provide strategic guidance on regulatory requirements, country-specific challenges, and risk mitigation solutions.
• Collaborate cross-functionally with project teams, sponsors, and regional stakeholders to drive successful study delivery.
• 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, promoting operational excellence and knowledge sharing.
• Support business development activities, including bid defenses, proposals, and client presentations.

Conocimientos

Leadership

Stakeholder management

Negotiation

Communication

Presentation

Project management

Financial acumen

Cross-functional collaboration

Educación

Bachelor's degree in Life Sciences

Herramientas

CTMS

Descripción del empleo

IQVIA Biotech seeks an experienced Study Start-Up Manager to lead site activation, regulatory, and maintenance activities for global studies. You will drive start-up strategies, timelines, resources, and budgets while ensuring compliance and quality across trials.

Strong leadership and cross-functional collaboration are required. The role requires 7+ years in clinical research or regulatory affairs, with international experience, proficiency in CTMS, and the ability to manage multi-country