The Study Start-Up Associate Director (SSU AD) is responsible at country level for organizing, overseeing and control the start-up component of the clinical trials conducted internally by SMM according to agreed resources and schedules in compliance with the AZ procedures, documents, local and international guidelines such as ICH – GCP and relevant regulations.
The SSU AD will oversee and provide direction for submission to Regulatory authorities and/or Ethics Committee, and any other start-up related activities agreed locally including local vendor management.
Typical Accountabilities
Ensure adequate resource planning for new work across TAs allocated to local SMM to enable timely allocation of staff during start-up period.
Ensure performance development of the SSU team (SSU managers and CSAs), as appropriate
Ensure ongoing coaching and development of SSU team and suppor...