Remote Global Study Start-Up Lead

IQVIA Argentina; Cataluña; Presencial; EUR 70.000 - 90.000; Jornada completa

Descripción de la vacante

IQVIA, a global leader in clinical research services, seeks an experienced Senior Clinical Project Manager to oversee start-up, regulatory strategy, and multi-country trial activations. You will drive timelines, ensure regulatory compliance, and coordinate cross-functional teams across regions, with home-based flexibility in Spain.

You will mentor teams, optimize CTMS usage, and contribute to business development through proposals and client engagements.

Formación

• Bachelor's degree in Life Sciences or a related field.
• 7+ years of experience in clinical research, study start-up, regulatory affairs, or a 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.
• Excellent leadership, stakeholder management, negotiation, communication, and presentation skills.

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

Regulatory affairs

GCP/ICH knowledge

Project management

Cross-country coordination

Stakeholder management

Communication

CTMS proficiency

Educación

Bachelor's degree in Life Sciences

Herramientas

CTMS

Descripción del empleo

IQVIA, a global leader in clinical research services, seeks an experienced Senior Clinical Project Manager to oversee start-up, regulatory strategy, and multi-country trial activations. You will drive timelines, ensure regulatory compliance, and coordinate cross-functional teams across regions, with home-based flexibility in Spain.

You will mentor teams, optimize CTMS usage, and contribute to business development through proposals and client engagements.