The Study Start-Up Manager (SSU Manager) is responsible at country level for managing and conducting start-up activities in compliance with the AZ procedures, documents, local and international guidelines such as ICH – GCP and relevant regulations.
The SSU Manager will prepare, review, track and manage site regulatory documentation at country and site level, and will maintain, review and report on site performance metrics.
The SSU manager works in close collaboration with the CRAs and the Local Study Team/Local Study Associate Director to ensure that study start-up activities and milestones are achieved in a timely and efficient manner.
Typical Accountabilities
Contribute to ensure that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
Accountable for study start-up and regulatory maintenance being in charge with collection, preparation, review and t...