Country Study Start-Up Specialist

📋 Description

• Ensure successful and on time and quality execution of start-up and maintenance activities for
• Competency in establishing the country/site activation plans and priorities including risk
• Proactively identify and communicate issues impacting delivery and providing proposed solutions.
• 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

🎯 Requirements

• Bachelor's Degree (degree in health care or scientific field) highly preferred or equivalent years
• A minimum of 1-2 years of clinical research experience and preferably 1+ years of study start up
• Experience working with remote/virtual teams.
• Strong interpersonal skills with the ability to build trust and communicate with clarity
• Working knowledge of ICH and GCP guidelines and operational understanding of the country's