Overview

Antes de solicitar este puesto, por favor, lea la siguiente información sobre esta posibilidad que encontrará a continuación.

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.

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

Requisitos principales

- 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 xugodme 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
- stakeholder management
- negotiation
- CTMS proficiency
- Regulatory affairs knowledge
- GCP / ICH familiarity

📌 Study Start Up Manager, IQVIA Biotech - barcelona
🏢 Jobrapido
📍 Barcelona