07 oct
|
AstraZeneca
|
Barcelona
07 oct
AstraZeneca
Barcelona
Location: Barcelona - Spain (3 days working from the office and 2 days working from home)
Introduction to the role
The Study Start-Up Associate Director (SSU AD) is responsible for organizing, overseeing, and controlling the regulatory and ethics committee (EC) start-up processes for clinical trials conducted by Site Management & Monitoring (SMM) at the country level. This role ensures all start-up activities are executed according to agreed resources and timelines, and in full compliance with AstraZeneca procedures, international guidelines such as ICH-GCP, and all relevant local regulations. The SSU AD leads and manages the Study Start-Up (SSU) team, setting clear objectives, and conducting ongoing performance management and follow-up, reporting to Director Country Head or /Director Site Management & Monitoring. The SSU AD provides leadership and direction for regulatory and Ethics Committee submissions and coordinates other start-up related activities as locally agreed.
The SSU AD is also accountable for driving continuous improvement in start-up processes and for establishing and maintaining high quality standards across all AstraZeneca internally managed studies.
Typical Accountabilities
Accountabilities for this role include:
• Ensure effective resource planning for new projects across assigned Therapeutic Areas within the local SMM team to allow timely staffing during the study start-up phase.
• Oversee the performance development of the Study Start-Up (SSU) team, providing guidance and regular development activities as needed.
• Deliver ongoing coaching and support to the SSU team and assist Local Study Associate Directors (LSADs) and Local Study Teams during study start-up, ensuring optimal team capability.
• Contribute to regional SMM initiatives and activities as appropriate, aligning start-up practices with broader organizational goals.
• Ensure that all activities performed by the SSU team at the country level are fully compliant with local policies
📌 Study Start Up Associate Director (Barcelona)
🏢 AstraZeneca
📍 Barcelona