Global Study Start-Up Lead

IQVIA; Lisboa; Presencial; EUR 70 000 - 110 000; Tempo integral

Resumo da oferta

IQVIA Biotech is seeking an experienced Study Start-Up Manager to lead site activation, regulatory and maintenance activities for global clinical studies. You will deliver start-up strategies, manage timelines and budgets, and ensure regulatory compliance across programs.

The role requires strong leadership, cross-functional collaboration, and proficiency with CTMS. You will mentor teams and contribute to business development through bids and client interactions.

Qualificações

• Bachelor's degree in Life Sciences or related field.
• Minimum 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 start-up activities.
• Excellent leadership, stakeholder management, negotiation, communication, and presentation skills.
• Strong financial, project management, and organizational capabilities.
• Demonstrated ability to manage multiple priorities across cross-functional teams.
• 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.

Conhecimentos

Leadership

Stakeholder management

Negotiation

Communication

Formação académica

Bachelor's degree in Life Sciences

Ferramentas

CTMS proficiency

Descrição da oferta de emprego

IQVIA Biotech is seeking an experienced Study Start-Up Manager to lead site activation, regulatory and maintenance activities for global clinical studies. You will deliver start-up strategies, manage timelines and budgets, and ensure regulatory compliance across programs.

The role requires strong leadership, cross-functional collaboration, and proficiency with CTMS. You will mentor teams and contribute to business development through bids and client interactions.