Global Study Start-Up Lead

Iqvia Biotech; Viseu; Presencial; EUR 70 000 - 110 000; Tempo integral

Resumo da oferta

A IQVIA Biotech está à procura de um Líder Global de Start-Up de Estudos para supervisionar iniciativas de site activation, regulação e manutenção em estudos clínicos internacionais. O papel exige experiência comprovada em start-up, regulamentação e coordenação entre equipas globais.

Responsável por estratégias de start-up, gestão de prazos, orçamentos e qualidade, bem como orientação de equipa e suporte a propostas de desenvolvimento de negócios.

Qualificações

• Bacharelado em Ciências da Vida ou área relacionada.
• 7+ anos em pesquisa clínica, start-up, assuntos regulatórios ou ambiente científico similar, com experiência internacional.
• Conhecimento sólido de regulamentação de ensaios clínicos, GCP, ICH e desenvolvimento de fármacos.
• Capacidade de liderança, gestão de stakeholders, negociação, comunicação e apresentações.
• Experiência em gestão de atividades de start-up multi-países e uso de CTMS.

Responsabilidades

• Conduzir ativação de sites global e atividades regulatórias desde início até manutenção.
• Desenvolver estratégias de start-up, planos de projeto e abordagens de submissão regulatória.
• Supervisionar submissões regulatórias, aprovações éticas, contratos e entregáveis de ativação.
• Colaborar com equipes de projeto, patrocinadores e parceiros regionais para entrega eficaz.
• Monitorizar progresso, métricas de qualidade, prazos, orçamentos e recursos.
• Mentorar e orientar membros da equipe, promovendo a excelência operacional.
• Dar apoio a atividades de business development, defesas de propostas e apresentações a clientes.

Conhecimentos

Liderança

Regulatory affairs

Clinical research

Project management

GCP/ICH knowledge

CTMS proficiency

Formação académica

Bacharelado em Ciências da Vida

Ferramentas

CTMS

Descrição da oferta de emprego

Global Study Start-Up Lead IQVIA Biotech•Piedade, Portuguese Republic, PT

Descrição do cargo

Bucuresti, Romania Belgrade, Serbia Lisbon, Portugal Barcelona, Spain Prague, Czech Republic Full time R1564053 Study Start-Up Manager IQVIA Biotech Job Overview IQVIA 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 global clinical trials. Key Responsibilities 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.

Qualifications & Experience Bachelor'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 organizational capabilities.

Demonstrated ability to manage multiple priorities and deliver results through cross-functional teams.

Proficiency with CTMS and other clinical research systems and technologies.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.Iqvia.Com IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud.

All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.

We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us. EEO Minorities/Females/Protected Veterans/Disabled