Global Study Start-Up & Site Activation Lead

IQVIA Inc; Lisboa; Presencial; EUR 85.000 - 125.000; Jornada completa

Descripción de la vacante

IQVIA Biotech is seeking a Study Start Up Manager to lead global site activation and maintenance for complex, multi‑protocol clinical studies. You will shape regulatory strategies, partner with cross‑functional teams, and drive start‑up milestones across regions.

The ideal candidate has a life sciences degree, 7+ years in clinical research or regulatory affairs, and proven leadership. You will mentor colleagues, manage timelines and budgets, ensure GCP/ICH compliance, and thrive in a fast‑paced

Formación

• Bachelor's Degree in Life Sciences or related discipline.
• Minimum of 7 years of experience in scientific, clinical research, regulatory affairs, or site activation.
• Experience in global or international clinical research programs.
• Strong understanding of the clinical trial lifecycle, drug development process, and regulatory requirements.
• Expertise in GCP, ICH guidelines, and applicable regulatory frameworks.
• Proven leadership experience with the ability to motivate, mentor, and influence others.
• Excellent project management, organizational, and financial management skills.
• Strong negotiation, communication, presentation, and stakeholder management abilities.
• Ability to manage multiple priorities and deliver results within complex, fast-paced environments.
• Proficiency with clinical systems, databases, CTMS platforms, and project tracking tools.

Responsabilidades

• Lead and oversee global site activation and maintenance activities for assigned clinical studies and programs.
• Develop and execute regulatory and site activation strategies that ensure timely study start-up and ongoing compliance.
• Partner closely with cross-functional study teams, clients, and country/regional stakeholders to achieve project milestones.
• Provide expert regulatory guidance and intelligence to support business development, bid defense activities, and study execution.
• Manage project scope, timelines, budgets, resources, and quality standards throughout the study lifecycle.
• Identify regulatory risks and challenges, developing innovative and practical solutions to accelerate study delivery.
• Oversee maintenance of clinical study approvals, essential documents, contracts, and regulatory submissions.
• Mentor and coach colleagues, fostering development and promoting operational excellence across teams.
• Build and maintain strong relationships with sponsors and key stakeholders while serving as a trusted subject matter expert.

Conocimientos

Leadership

Regulatory affairs

GCP/ICH

Project management

Stakeholder management

Clinical research

Educación

Bachelor's degree in Life Sciences

Herramientas

CTMS

Descripción del empleo

IQVIA Biotech is seeking a Study Start Up Manager to lead global site activation and maintenance for complex, multi‑protocol clinical studies. You will shape regulatory strategies, partner with cross‑functional teams, and drive start‑up milestones across regions.

The ideal candidate has a life sciences degree, 7+ years in clinical research or regulatory affairs, and proven leadership. You will mentor colleagues, manage timelines and budgets, ensure GCP/ICH compliance, and thrive in a fast‑paced