Study Start-Up ManagerIQVIA BiotechJob OverviewIQVIA Biotech is seeking an experienced Study Start-Up Manager to lead and oversee all site activation, regulatory, and maintenance activities for assigned clinical studies and programs. This role is accountable for delivering study start-up strategies, managing timelines, resources, budgets, and regulatory requirements, while ensuring high-quality execution and compliance across general clinical trials. Key ResponsibilitiesLead 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.
Qualifications & ExperienceBachelor's degree in Life Sciences or a related field.
Minimum 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. Strong financial, project management, and org

📌 Study Start Up Manager, IQVIA Biotech (Barcelona)
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📍 Barcelona