Senior Specialist, Country Study Start Up

📋 Description

• Ensure successful and on time and quality execution of start-up and maintenance activities for
• Advanced competency in establishing the country/site activation plans and priorities including risk
• Attend regional/area start up calls and provide input for assigned sites/studies.
• Collection of essential documents from sites and completing quality check (ALCOA).
• Compile and submit ethics and other required local document packages including customization of
• Coordinate with Regulatory and CTS on CA submission and approval status to assure alignment with

🎯 Requirements

• Bachelor's Degree (degree in health care or scientific field) highly preferred or equivalent years
• Senior experience of clinical research and study start up management experience for the designated
• Must have hands on experience in interpreting regional clinical research regulations and processes.
• Experience working with central and local IRB/EC sites, inclusive of reviewing site and/or IRB/EC
• Adept and experienced working with Vault SSU in the capacity of essential document processing, IP
• Experience working with remote/virtual teams.