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 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, regulations, and the company code of ethics.
Provide
📌 Study Start Up Associate Director (Barcelona)
🏢 AstraZeneca
📍 Barcelona
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