Global Study Start-Up Lead: Regulatory & Activation

IQVIA; Oeiras; Presencial; EUR 90 000 - 125 000; Tempo integral

Resumo da oferta

IQVIA Biotech is seeking an experienced Study Start-Up Manager to lead site activation, regulatory activities and maintenance across global programs. The role drives timelines, budgets and compliance while coordinating cross-functional teams.

The ideal candidate has 7+ years in clinical research or regulatory affairs, strong leadership, and CTMS proficiency. This position supports business development through bids, proposals and client presentations.

Qualificações

• Bachelor's degree in Life Sciences or related field.
• 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 drug development.
• Proven experience managing complex, multi-country start-up activities.
• Leadership, stakeholder management, negotiation, communication and presentation skills.
• Financial, project management and organizational capabilities.
• Ability to manage multiple priorities with cross-functional teams.
• Proficiency with CTMS and clinical research systems.

Responsabilidades

• Lead global and regional site activation and regulatory activities from start-up through maintenance phases.
• Develop and execute study start-up strategies, project plans, and submission approaches to achieve 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.
• Collaborate cross-functionally with project teams, sponsors, and regional stakeholders to drive 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

Regulatory knowledge

Project management

Cross-functional collaboration

Communication

Formação académica

Bachelor's degree in Life Sciences

Ferramentas

CTMS

Descrição da oferta de emprego

IQVIA Biotech is seeking an experienced Study Start-Up Manager to lead site activation, regulatory activities and maintenance across global programs. The role drives timelines, budgets and compliance while coordinating cross-functional teams.

The ideal candidate has 7+ years in clinical research or regulatory affairs, strong leadership, and CTMS proficiency. This position supports business development through bids, proposals and client presentations.