Senior Specialist, Country Study Start Up

Key Responsibilities:

• Drive and execute all start-up and maintenance activities for assigned studies and sites within the country (or countries).
• Ensure on-time, on-budget, quality delivery of start-up and maintenance activities, particularly for single-country studies.
• Act as a site start-up expert; support, train, and mentor Specialists, Country Start Up in new technologies and processes.
• Establish country/site activation plans, risk assessment and mitigation in collaboration with cross-functional leads.
• Proactively identify, communicate, and address issues impacting study delivery.
• Attend regional/area start-up calls and provide study/site input.
• Collect and quality check essential documents from sites (using ALCOA standards).
• Prepare and submit ethics and local required submissions, customize ICFs and patient/safety materials.
• Coordinate with Regulatory and CTS fo...