Global Study Start-Up Lead: Regulatory & Site Activation

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

Descripción de la vacante

IQVIA Biotech is seeking an experienced Study Start-Up Manager to lead site activation, regulatory submissions, and maintenance for global clinical studies. You will drive start-up strategies, manage timelines, budgets, and regulatory requirements while ensuring high-quality execution and compliance.

Responsibilities include overseeing submissions, ethics approvals, essential documents, contracts, and cross-functional collaboration with sponsors and regional teams.

Formación

• Bachelor's degree in Life Sciences or related field.
• 7+ years in clinical research, study start-up, regulatory affairs, or similar, with international exposure.
• Strong knowledge of clinical trial regulations, GCP/ICH, and drug development.
• Experience leading multi-country start-up activities and cross-functional teams.

Responsabilidades

• Lead global and regional site activation and regulatory activities from start-up through maintenance.
• Develop and execute start-up strategies, project plans, and regulatory submission approaches.
• Oversee regulatory submissions, ethics approvals, essential documents, contracts, and deliverables.
• Provide strategic guidance on regulatory requirements and risk mitigation.
• Collaborate with project teams, sponsors, and regional stakeholders to deliver studies.
• Monitor progress, quality metrics, timelines, budgets, and resources.
• Maintain project data in 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 skills

Financial management

Project management

Organizational capabilities

CTMS proficiency

Cross-functional collaboration

Educación

Bachelor's degree in Life Sciences or related field

Herramientas

CTMS

Descripción del empleo

IQVIA Biotech is seeking an experienced Study Start-Up Manager to lead site activation, regulatory submissions, and maintenance for global clinical studies. You will drive start-up strategies, manage timelines, budgets, and regulatory requirements while ensuring high-quality execution and compliance.

Responsibilities include overseeing submissions, ethics approvals, essential documents, contracts, and cross-functional collaboration with sponsors and regional teams.