Study Start Up Specialist

Job Summary

Assuming leadership during the study start-up process, the full-time Study Start Up Specialist will coordinate site activations, manage regulatory deliverables, and serve as the primary contact for sponsors and internal stakeholders in a remote work environment.

Key responsibilities

• Lead the development of start-up strategies and ensure compliance with regulatory requirements and project timelines
• Act as the main point of contact for all project-specific Study Start-Up activities and facilitate communication with selected sites
• Prepare and review regulatory submissions and essential documents to support efficient site initiation and activation

Required qualifications

• Bachelor's Degree in Chemistry, Life Sciences, Nursing, or equivalent experience
• Minimum of 5 years of experience in the pharmaceutical or CRO industry
• Proven ability to manage multi-country projects in start-up
• Outstanding knowledge of ICH-GCP across all areas
• Excellent organizational, planning, and problem-solving skills