14 oct
|
AstraZeneca
|
Barcelona
14 oct
AstraZeneca
Barcelona
Experteer Overview
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As Study Start-Up Associate Director, you will lead regulatory and Ethics Committee start-up activities for local trials within Site Management u0026amp; Monitoring. You will manage the SSU team, ensuring staffing, performance development, and timely site activation in line with AstraZeneca procedures and ICH-GCP. You will collaborate with stakeholders to optimize start-up processes, drive continuous improvement, and uphold high-quality standards across studies. This role offers the opportunity to shape start-up practices, influence regional initiatives, and contribute to a patient-focused mission in a general pharma environment.
Compensaciones / Beneficios
• Plan and optimize resource allocation for new projects during the start-up phase
• Oversee SSU team performance and development activities
• Coach LSADs and study teams to enhance start-up capability
• Align start-up practices with regional goals and broader organizational objectives
• Ensure compliance with local policies, regulations, and company ethics
• Provide project oversight up to site activation and smooth handover
• Guide LSADs and SSU members on best practices and issue resolution
• Act as a key escalation point for complex start-up issues
• Serve as local process owner for SSU, maintaining guidelines and templates
• Engage with external stakeholders to influence and optimize start-up processes
• Support feasibility activities and country selection where xghoner decided locally
Responsabilidades
• Bachelor's degree in related discipline
• Pharmaceutical industry experience, preferably in Clinical Operations (CRA/Sr.CRA/LSAD) or related fields
• Strong knowledge of drug development, GxP, ICH-GCP, and local regulations
• Ability to manage cross-functional teams and external stakeholders
• Willingness to travel nationally/internationally
• Proven p
📌 Study Start Up Associate Director (Barcelona)
🏢 AstraZeneca
📍 Barcelona